Quality Specialist Resume Samples

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J Osinski

Julian

Osinski

183 Jed Forks

San Francisco

+1 (555) 420 5856

183 Jed Forks

San Francisco

Phone

p +1 (555) 420 5856

Experience Experience

Detroit, MI

Quality Specialist

Detroit, MI

Fay-Spencer

Detroit, MI

Quality Specialist

Uses knowledge to improve Quality Systems, provide continuous improvement and execute tasks
Analyzes non-conformance and KPI data for trends, develops reports for management and initiates Continuous Improvement projects to improve processes
Collaborate with center management in the development and implementation of continuous improvement plans
Work with Failure Mode Analysis outcomes to provide process efficiency assistance
Provides Portfolio leadership with respect to integrating quality into the way it does business, to improve its performance
Initiates Continuous Improvement projects to both resolve Portfolio problem areas and to develop opportunities for improvement
Provide coaching tips and training suggestions to managers for targeted areas for improvement

present

Boston, MA

Quality Specialist

Boston, MA

Ortiz-Heller

present

Boston, MA

Quality Specialist

present

Proactively self-develop, by working with your site Quality Manager to identify Learning & Development initiatives for individual growth and site improvement
Report data on quality performance to CEO’s and senior management teams and make recommendations to improve internal workflow processes globally
Work closely with assigned business to ensure all improvements are driven correctly, provide feedback on on-going efforts & identify new areas of improvement
Develop and communicate monthly scorecards and performance improvement results to Central Audit Manager and Quality Director
Assist the Quality Manager with decisions through providing reports on quality of service as well as project updates and areas of process improvement
Assists in developing quality systems & make recommendations for improvements to existing Quality systems
Manages defects and works with development team to provide resolutions

Education Education

Bachelor’s Degree in Computer Science

The University of Alabama

Bachelor’s Degree in Computer Science

Skills Skills

Banking operations experience
Excellent at grasping the customer experience impact by level of knowledge of Customer Experience attributes and ability to think situationally based on each call and itÆs uniqueness
Ability to lead peers and supervisors in a call calibration setting
Proven high level of customer service delivery
Ability to identify trends in data and call patterns
Ability to work in a repetitive environment
Ability to coach agents on call handling and customer experience
Ability to identify specific behavior patterns
Superior verbal and written communications skills
Excellent follow-up skills

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Quality Specialist Resume Examples & Samples

High School Diploma or GED equivalent is required
2 years mortgage servicing/processing experience preferred
Thorough understanding of department/unit policies and procedures and basic understanding of related department policies and procedures for mortgage servicing required
Thorough knowledge of state, regulatory, & investor guidelines for mortgage servicing
Experience working in the mortgage industry and working with mortgage documents
Interaction with external/internal customers
Advanced data entry, typing and filing skills
Proficient problem solving and research skills
Ability and willingness to lift and maneuver 30-pound banker boxes and maneuver heavy mobile filing carts

Quality Specialist Resume Examples & Samples

2+ years direct operations experience
Quality and/or Audit experience preferred
Prior experience in multiple Operations functions
High school diploma or GED or equivalent experience

Quality Specialist Resume Examples & Samples

High School Diploma or GED is required
Thorough understanding of department/unit policies and procedures and basic understanding of related
Ability and willingness to lift and maneuver 30-pound banker boxes and maneuver heavy mobile filing

Quality Specialist Resume Examples & Samples

Performs call monitors for any new initiatives to the Quality Team, including Service to Solutions and Escalations
Performs assessment of Commercial Support Center representativeÆs performance via monitoring
Leads Commercial Calibration sessions with managers, agents and supervisors
Responsible for adhering to our internal standards of CARES quality while keeping the customer experience in mind
Acts as a change agent, driving our direction to customer excellence through coaching, feedback and CARES audits
Works to ensure the management team and quality team are aligned in our overall direction in addition to our scoring on our internal CARES form
Responsible for identifying and communicating trends within the agent population to the quality manager making recommendations for changes
Provides feedback to operations leadership on representative performance for coaching to the representatives
Identifies specific improvement opportunities
Partners with Contact Center management to create specific action plans that address improvement opportunities for individuals and across the call center
Creates and implement measurement tools to gauge the effectives of coaching improvement plans
Completes all necessary skill certifications
Provides feedback to Contact Center management on frequently heard customer comments. Based on customer feedback, make recommendations for new products or services or enhancements to existing ones as well as process or policy suggestions
Makes recommendations for customer service and productivity improvements based on observations and data
Compiles data from call center systems, and may assist in analysis of data and processes, as part of the Contact CenterÆs commitment to continuous improvement
Acts as a coaching resource for agents as directed by Quality Manager or Contact Center management
Participates in activities that ensure calibration of the quality monitoring program
This position has quality and productivity requirements tied to monthly performance
Participate in special projects as needed and perform other duties as assigned
Assist on phone calls as needed to assist with Service Level
High school education or equivalent required, college degree or experience preferred
3 years of internal contact center or customer service experience required
Banking operations experience
Leadership experience strongly preferred
Excellent at grasping the customer experience impact by level of knowledge of Customer Experience attributes and ability to think situationally based on each call and itÆs uniqueness
Ability to lead peers and supervisors in a call calibration setting
Excel and powerpoint skills preferred
Proven high level of customer service delivery
Ability to identify trends in data and call patterns
Ability to work in a repetitive environment
Ability to coach agents on call handling and customer experience
Ability to identify specific behavior patterns
Superior verbal and written communications skills
Excellent follow-up skills
Outstanding listening skills, and the ability to process auditory information very quickly

Quality Specialist Resume Examples & Samples

Attention to detail during transferring information to other,
Skills of preparation reports are preferred
Good skills of self-organization and self-control
Good command of Russian & English is preferable
Expert proficiency using Microsoft Office required

Quality Specialist Resume Examples & Samples

SME for assigned quality systems providing ongoing guidance and direction to Associates at all levels in the organization
Update and maintain the Approved Supplier List and Approved Materials List. Approve Suppliers and materials/services as required
Conduct/participate in supplier audits. Work with suppliers to ensure corrective action plans are developed and implemented for non-conformances identified
Assess requirement for and develop Quality Agreements/Commitments. Lead Supplier Review Board
Manage and drive continuous improvement activities focusing on Supplier Quality
Identify and leverage best practices in relation to Supplier Quality Management
Lisaise with Procurement function to develop and execute Supplier development Programmes such as: Supplier Sourcing; Supplier Approval; Supplier Management, etc. Manage Supplier Change Requests
Review and approval of First Articles and development of Incoming Inspection criteria
Support preparation, review, approval and execution (where applicable) of site related documentation (Procedures, Forms, Transfer Strategies / Plans etc.)
Support the development and implementation of quality reporting metrics
Track and trend key quality indicators and issue reports. Prepares presentations for Management Review Meetings
Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11
Minimum qualification B.Sc Degree in one of the following disciplines: Chemistry, Biochemistry,
Biotechnology Biochemical or Chemical Engineering, Chemistry, or equivalent discipline
6 Years or more post educational experience working in a regulated environment, preferably within a Pharma/Biotech facility
Knowledge of EU/US quality related Biological/pharmaceutical/Medical Device regulations

Quality Specialist Resume Examples & Samples

Conduct workplace quality assessments by collecting statistically significant samples to review and record ticket handling accuracy across a global organization encompassing several distinct and often complex processing flows
Work with LERT partners to update training materials that ensure team members are able to make consistent and accurate decisions related to request handling
Compile and evaluate quality assesment data to determine trends and assist with resource identification
Track corrective actions and work with teams to address quality results
Act as a trusted partner and advisor to LERT as they implement new law enforcement request handling solutions to ensure that they follow a structured systems development life cycle that include success measures and risk identifiers
Stay connected with how our support ecosystem is evolving and help head off quality issues before they begin
Collaborate with cross-functional partners in Operations & and on LERT to develop and implement system requirements to monitor the quality of our team's decisions
Drive accountability with your team lead peers and their teams to meet quality performance goals and ensure program standards are met on a week-over-week basis
Effectively partner with a team responsible for diverse workflows, quality channels, and global stakeholders
Find creative workarounds for quality issues where our tools are the root cause and a technical solution is not imminent
Implement processes and metrics to oversee and ensure LERT is able to measure and reach quality goals
Prepare technical reports containing compliance status analysis, identifying non-compliance/non-conformance conditions and recommending actions to correct and prevent recurrence
Quantify the impact of not changing and drive cross-functional partners to change our systems, processes and policies to achieve better outcomes

Quality Specialist Resume Examples & Samples

Maintain Quality Management System
Ensure compliance and accuracy is performed on aircraft logbooks, historical records, and maintenance
Monitor component TBO cycles
Continuous Improvement/ACE
Act as Quality primary on site contact for Stuart Training Center

Quality Specialist Resume Examples & Samples

Quality test numerous processes within Chase Auto Finance and/or Chase Student Loans to ensure procedures are followed
Ability to analyze the process from beginning to end and provide recommendations where controls are needed
Ability to adapt to changing requirements while ensuring quality adherence
Daily interaction with project team, including processors, project managers, and remediation execution managers
Must stay current on all policies and procedures to incorporate that knowledge into thorough reviews
3-5 years experience in Chase Auto Finance and/or Chase student Loans is preferred
3-5 years of control testing assurance experience is preferred
Must be capable of multi-tasking and prioritizing in a time sensitive environment
Must maintain a high level of accuracy with attention to detail
Highly motivated team player
Background in SCRA is a plus

Quality Specialist Resume Examples & Samples

Performs assessment of Consumer and/or Commercial Contact Center representativeÆs performance via monitoring
Responsible for adhering to our internal Quality standards while keeping the customer experience in mind
Works to ensure the management team and quality team are aligned in our overall direction in addition to our scoring on our internal Quality form
Responsible for identifying and communicating trends within the agent population to the quality manager
Partners with Contact Center management to create specific action plans that address improvement opportunities for individuals
Provides feedback to Contact Center management on frequently heard customer comments
Minimum of 3 years previous contact center or customer service experience required
Banking operations experience strongly preferred
Superior banking product knowledge

Quality Specialist Resume Examples & Samples

2 years' experience in healthcare setting
Excellent interpersonal, communication, organization and writing skills with the ability to effectively prioritize work
Commitment to enhancing member experience
Knowledge of HEDIS quality measures
Knowledge of utilizing electronic medical records systems
Experience with HEDIS
Experience with HCC
Experience with PCMH

Quality Specialist Resume Examples & Samples

HS Diploma or equivalent Thorough knowledge of the operational processes, procedures and systems
Strong problem solving skills. Solid / polished interpersonal and communication skills
Demonstrated analytical ability

Quality Specialist Resume Examples & Samples

Ensuring the effective implementation of a quality management system
Particular responsibilities include
Documentation: procedure writing and review, implementation of new procedures and policies
Bona Fides checks on both customers and suppliers
Management and inspection of returned product in a fast moving, GDP environment
Training: including GDP and procedural based training
Auditing: periodic internal auditing duties, auditing of external vendors
Temperature monitoring
Calibration and maintenance of equipment
Validation: temperature mapping and software validation
Participation in other projects/duties as defined by the Group Quality Manager
Relevant experience in pharmaceutical distribution environment
Third level qualification in scientific discipline
Proven problem solving ability in a busy, fast moving environment
Validation experience an advantage
Good working knowledge of Microsoft applications
Experience in an SAP environment preferred

Quality Specialist Resume Examples & Samples

Review batch record to support release of finished product
Maintenance of master batch record to support release
Transfer of results on SAP QM, review any out of specification results with relevant Manager, create and maintain SAP master data and searches
Reporting including Positive Release on time in full and Cost of Quality
Key reviewer and approver of finished product specification
Conduct Annual Product Review
Support investigations into final product deviations
Co-ordinate and manage Plant sensory panel and report on outcomes
Co-ordinate the despatch of samples to customers
Degree in Food Science or equivalent
Aptitude for technical administrative processes
Computer literate in Microsoft Office suite & a working knowledge of SAP or equivalent ERP process
Strong communications with multi-functional stakeholders, including customers
Knowledge of Dairy products, processes and recipes an advantage
Lean, continuous improvement
Dedicated to meeting the expectations and requirements of internal and external customers

Quality Specialist Resume Examples & Samples

Ensure quality records and documentation is of high standard
Lead the quality and production team to ensure the manufacturing facility and products meet all applicable quality system standards
Maintain compliance with regulatory agencies
Carry out weekly hygiene audits along with promoting food safety and hygiene throughout the company
Ensure all staff are trained appropriately for their role for quality and hygiene standards
Provide guidance & support for new and on-going improvement projects throughout the site
Degree/Diploma/Qualification in Food, Science or equivalent
Minimum of 2 years' experience in a similar role ideally in the food/pharma production industry
Extensive experience maintaining specifications, procedures and Quality Systems across HACCP and BRC is required
Ability to work on own initiative and also in a team manufacturing environment

Quality Specialist Resume Examples & Samples

Customer Relations Team / PC skills
Extensive knowledge of policies and procedures
Effective interpersonal and communication skills
Independent thought / objectivity
18 months experience in operations and demonstrated performance in job function

Quality Specialist Resume Examples & Samples

Thorough knowledge of the Recovery operational processes, procedures and systems with extensive experience utilizing the CitiSource application
Solid/polished interpersonal and communication skills
Experience in the Technical Writing field a plus, but not required

Quality Specialist Resume Examples & Samples

2+ years' experience in a healthcare setting
Commitment to enhancing member experiences
Proficient in Microsoft Word, Excel, and PowerPoint
2+ years of experience in quality-related activities

Quality Specialist Resume Examples & Samples

Monitor inbound and outbound phone calls
Review outgoing written correspondence to ensure thorough resolution and professional presentation
Review cases/letters for complete documentation and accurate coding
Enter quality observation details in a database and track specialist and group performance
Coach individual specialists on observed opportunities and best practices
Participate in ad-hoc projects and initiatives related to quality as needed
Minimum of five years customer service experience
Customer-centric Focus
In depth knowledge of Chase products and services
Strong organizational skills – must be able to multi-task
Ability to remain focused on a large volume of repetitive transactions
Flexible and able to adapt to changing environment and goals
Working knowledge of MS Office Applications (Word, Excel, Powerpoint, etc…)

Quality Specialist Resume Examples & Samples

Primarily performs the quality assessment on a monthly basis for all underwriters and post approval analysts within the small business lending group and inputs information into QC application
Works within daily, weekly, and monthly production goals and tracks progress of team to ensure completion of goals
Monitors daily, monthly, and yearly performance statistics of employees and provides/presents findings to management
Performs analysis of quality review process and recommends updates to management as required
Reviews and works through departmental reports as required
Compiles and delivers information for MCA Testing as required
Assists with system testing as needed
Other duties as assigned/delegated by management
Interacts with all levels of managers and internal departments to resolve complex problems
Works under little to no direct supervision to perform job functions
Two years of related experience at a senior representative level
Two or more years of experience with credit operations or quality control
Knowledge of quality control
Knowledge of banking regulations and policies
Analytic skills
Must exhibit understanding of banking policies and procedures
Must use Word and Excel programs effectively
Ability to multi-task required
Solid communicate skills
Must demonstrate sound judgment and communication skills, both oral and written
Must be able to work collaboratively with other departments to meet goals

Quality Specialist Resume Examples & Samples

Responsible for executing validation studies. This includes risk assessments, protocol generation, field execution, data analysis, and report generation. This responsibility also requires coordination of studies with Quality Control, Operations and Engineering
Analysing statistical data to determine process capability
Execution and documentation of process risk assessments and FMEAs
Execution of validation protocols and recording of data in compliance with GXP
Accountable for scheduling, tracking, reporting and achieving project deadlines
Participates in internal and external audits and inspections where required
Willingly accepts challenging assignments
Direct experience performing validation studies including computer system validation in a cGMP pharmaceutical environment is required

Quality Specialist Resume Examples & Samples

Executes on aligned operational and analytical activities by utilizing the appropriate analytical review procedures using industry frameworks and review standards to oversee basic to complex IT processes
Advanced working knowledge of the critical components aligned to IT processes
Advanced working knowledge of the Critical Success Factors (CSF) and KPIs aligned to a specific process to effectively analyze the process, review related procedures and standards in input/output of data and recommend change
Advanced analytical abilities to effectively compare data elements against these control metrics using frameworks / standards such as ITIL, ISO and other guidelines for multiple IT processes
Ability to drive and deliver on multiple and shifting assigned priorities to provide audit results and identify and prescribe solutions that are timely, accurate and effective
Advanced interpersonal skills to engage in or lead cross business/team discussions within a matrixed, geographically dispersed organization and to formulate or drive, as required, credible ideas or insightfully challenge proposed options
Advanced communication skills, both oral and written in the English language, to summarize key issues and findings, to formulate supportive ideas and materials as well as present complex findings and ideas clearly and concisely to a variety of levels of the organization including senior management
Certified in the advanced knowledge and use of Information Technology Infrastructure Library (ITIL) processes as well as International Organization for Standardization (ISO) guidelines that are applicable to IT processing (ISO 9000, 20000, 27001 etc.) with an eye to progressive levels of certification as required. Leverages industry standard process directives/guidelines in reviewing current process and directing change
Advanced understanding of IT processing standards and how they integrate, enhance and enable IT Service delivery
Intermediate to advanced skills in Microsoft Office products, predominantly Excel, Visio and PowerPoint

Quality Specialist Resume Examples & Samples

Provide reliable and timely assessment of the level of good manufacturing practices (gmp) compliance of quality systems, processes, tools and resources of third party manufacturers
Inform management of any critical audit finding or product out of specification in a timely and expert manner
Issue audit reports in a timely and expert manner
Collect and analyze key performance indicators (kpi) as reported in the quality assurance reports/scorecards and follow up with the TPM
Provide support in the field of technical expertise to other quality assurance and packaging functions to achieve the company objectives
Manage Coty retention samples inventory
Effectively work and communicate with suppliers
Perform chemistry tests such as pH, viscosity, RI & specific gravity on bulk & finished goods
Perform verification of sanitization & cleanliness of manufacturing equipment
Write/revise standard operating procedures
Maintain MTS Product dossiers under the direction of Technical Director
Troubleshoot batch chemistry issues
Release products in SAP once approved
Maintains a clear understanding and working knowledge of GMP requirements, Safety requirements, and SOP’s. Adheres to and enforces those policies within the team
Knowledge in Over-The-Counter (OTC) FDA requirements is a plus
Strong sense of individual accountability
Intermediate knowledge in SAP is a plus
Language skills as well as fluent written and spoken English skills required; knowledge of other languages such as French, German, Italian, Spanish is an asset
Is open to the creative ideas of others
Establishes recognized expertise
Makes decisions and takes actions that are right for the Company
Consistently meets or exceeds agreed upon results
Supports team decisions, even when they personally disagree
Willingly shares knowledge and experience with colleagues
Able to motivate & positively influence others
Constructive Networker

Quality Specialist Resume Examples & Samples

Provides customer service with regard to all facets of customer contact and operations analysis
Reviews work processes and recommends improvements
Analyzes key performance indicators and other operational metrics
Implements new methods and techniques for operational improvement
Collaborates with managers in the identification, prioritization, planning development, coordination, support, and execution of high-impact plans for effective and sustainable cost savings

Quality Specialist Resume Examples & Samples

Familiarity with Citi Source Knowledge HUB is preferred
Prior experience in quality review and technical writing is a plus
Prior work experience in a related job that would provide a good understanding of activities, policies, procedures, and concepts of the work area

Quality Specialist Resume Examples & Samples

Upgrading to and implementation of quality assurance standard i.e. ISO 9001:2015
Implementation of BRC Agents & Brokers accreditation as part of QM + HACCP systems
Vendor Approval Process Overhaul
Co-ordination and management of investigations, reports and responses to customers complaints with the required timelines
Liaising with suppliers to resolve supplier complaints
Completion of Quality Agreements and Technical Quality Agreements
Auditing; periodic internal audits, auditing of external vendors and service providers when required
Assisting in preparation for and participation in regulatory and customer audits
Management of questionnaire completion
SQAS Distributor (ESAD) maintenance and completion
Responsible Care Co-Ordinator
GTDP implementation, training and management
End User + Long Term Vendor Declarations
Implementation of SLA's with Third Party warehouse/hauliers
Customer RFI's
AEO Operator implementation
Degree in a Science related discipline
Minimum of 3 yrs QA experience
Comprehensive knowledge of ISO standard's (ISO 9001:2008 / 9001:2015)
Excellent written & verbal communication skills
Excellent organisation skills
Ability to be self-driven and capable of working on own initiative as well as part of a team

Quality Specialist Resume Examples & Samples

Conducts regularly scheduled quality reviews for agents (Benefit Analysts, Escalation Analysts, and Benefit Call Representatives (BCRs)
Conducting call monitors using Quality Scorecards, providing feedback to the agents and identifying coaching opportunities
Conducting claim file audits and escalation audits based upon client policy/procedures
Communicate with management team about areas of opportunity or any agents hat are not meeting standard
Identify performance trends and patterns and make appropriate training recommendations as well as recommendations for policy and procedure changes that may enhance service productivity
2 + years of quality assurance experience, preferably in a contact center environment
Ability to provide direct feedback and one-on-one coaching
Possesses good working knowledge of adult learning styles, theories, and methods
Excellent verbal and written communications skills
Must be comfortable with technology and able to fully utilize PC office products such as Word, Excel, Power Point, and Outlook
Ability to work independently and meet deadlines with strong organizational, analytical, and problem-solving skills while fostering an environment of open communication and teamwork
Bilingual (English and Spanish) strongly preferred

Quality Specialist Resume Examples & Samples

Requires sitting at a computer the majority of an 8-hour shift
Position requires ability to lift/maneuver 30 lb. banker’s boxes and push/pull fully loaded wooden carts
May assist with pulling files or re-filing files which required standing, stooping, bending, and stretching
Must have excellent attention to detail and accuracy
Must have proficient data entry, typing and filing skills

Quality Specialist Resume Examples & Samples

Active New Jersey State Registered Nurse license
Strong medical skills and knowledge
3+ years of previous experience in quality or Performance Improvement

Quality Specialist Resume Examples & Samples

High Attention to Detail and Quality within work
Proficient SharePoint and Excel knowledge as well as general PC Skills
Effective Interpersonal and written and verbal communication skills
Independent thought/objectivity; prior audit or quality control experience
Ability to learn multiple processes quickly

Quality Specialist Resume Examples & Samples

A key member of Division Quality Leadership Team tasked with the development, implementation and management of an International Organization for Standardization (ISO) 9001:2015 compliant Quality Management System (QMS)
Represent the Quality Engineering function in cross-functional, new product commercialization and product maintenance teams
Drive Product and Process Understanding (PPU), including a focus on Critical to Quality (CTQ) characteristics, application of Statistical Process Control (SPC) and Design of Experiments (DOE)
Lead migration of Document Control from Lotus Notes/MDI to 3M Global PLM/Enovia, including User education and Admin responsibility for the IMPD Enovia vault
Lead IMPD migration to SAP Quality Management, including pull forward implementation of Internal Auditing and Corrective Action Preventive Action (CAPA) modules; represent IMPD on SGBG SAP Quality Management (QM) Implementation Team
Manage division quality metrics, including Defective Parts per Million (DPPM), Customer Complaint Response Time (CCRT), Critical Quality Index (CQI), Right the First Time (RTFT), CAPA and Customer Feedback Resolution (CFR) summarization
Lead QMS internal auditing
Bachelor’s degree or higher in a Science, Technology, Engineering or Mathematics (STEM) discipline from an accredited institution
Minimum of seven (7) years of combined experience in a Process Engineering and/or Quality Engineering environment
Bachelor’s degree or higher in Engineering, Statistics or related discipline from an accredited institution
Working knowledge of 3M IT solutions (Lotus Notes MDI, CFR and Enovia—applies to internal applicants only)
Implementation of ISO compliant QMS
Implementation of 3M IT solutions
Lean Six Sigma (LSS) Black Belt
Results oriented and self-motivated with proven ability to manage multiple projects with business focused prioritization
Demonstrated competency in Process Product Understanding (PPU), Statistical Process Control (SPC), Design of Experiments (DOE), Measurement Systems Analysis (MSA), Gage Repeatability and Reproducibility (GR&R), Failure Modes & Effects Analysis (FMEA), Define – Measure – Analyze – Improve – Control (DMAIC) methodologies
Strong interpersonal and teamwork aptitude
Strong written and presentation communication skills, including ability to clearly articulate quality policy and work instructions
Experience leading a cross functional team

Quality Specialist Resume Examples & Samples

Ensure product is manufactured in accordance with the sites quality management system. Maintain and optimize implementation of Mondelez Quality Policies (QP’s). Provide coaching and training to production staff
Ensure food safety of all manufactured Candy products by ensuring understanding and compliance with regulatory and corporate requirements (e.g. HACCP) Participate and by continuous verification of the compliance and effectiveness of installed systems
Assure quality by ensuring all specification parameters are met and corrective action plans are in place to address non-conformances
Lead teams to identify root cause and deliver action plans for Key Drivers of first pass quality/waste deviations (i.e. faulty)
Manage and/or lead internal and external change projects assigned
Ensure quality requirements are met before accepting new/improved products, processes and equipment into Candy making by ensuring appropriate linkages and technology transfer with Research and Development and all plant lead changes (e.g. Capital projects, productivity projects and plant change requests)

Quality Specialist Resume Examples & Samples

Support the site Quality compliance plan to drive a culture of everyday Quality compliance
Develop and support the maintenance of all aspects of the Quality Management system
Facilitate the management of internal non-conformances driven by product failure, compliance gaps, internal audits or complaints
Facilitate others in the process of root cause and preventive action investigations including the evaluation of preventive action effectiveness
Provide training, coaching and support for problem solving techniques and tools
Support the direction of implementation of QC standards, rules and procedures
Determine and maintain Quality Control plans for current and new products in order to control product quality
Support HACCP management and compliance, supporting the creation and maintenance of HACCP documentation
Support and direct quality related training e.g. HACCP, GMP, and Problem Solving etc
Support the site to fully embed best sanitation practices and compliance to the Mondelez Sanitation QP
Complete and follow up internal Quality compliance audits
Support and participate fully in site accreditations for food safety and Quality compliance audits. Manage compliance to these accreditations through effective quality system management
Support new product introduction and site change activity, to provide quality input in to the change management process
Support the manufacturing teams to embed quality practices
Lead the setting of QC requirements within manufacturing
Present evidence that helps support capital investment from a compliance and operational improvement perspective
Support the process to remove risks that may lead to consumer harm or dissatisfaction, regulatory adverse comment and/or damage to the Mondelez brand(s)
Immediate communication of any quality high risks to the site Quality and Foods Safety Manager and agree activities
Know the legal and compliance responsibilities of the position; raise questions and concerns when faced with, or you learn of, an ethical or compliance issue; apply integrity in all aspects of professional conduct
Degree or equivalent e.g. Chemistry, Microbiology, Food Science, Nutrition, Food Technology or related field
Quality auditing skills. HACCP, Sanitation and hygienic design knowledge
Quality techniques/6 sigma knowledge preferred
Systematic and structured with the ability to drive high standards and expectations
Tenacity and resilience
Strong understanding and practical application of HACCP
Expert in root cause analysis and issues resolution
Strong practical experience of systems, implementation and control
Practical experience of developing and implementing Quality and Food Safety Management Systems

Quality Specialist Resume Examples & Samples

Conduct quality checks by proofreading/reviewing document sentence by sentence
Evaluate employee performances and ensure that any work produced meets client specifications
Manage recorded data for quality metrics reports and analyze trends
Report data on quality performance to CEO’s and senior management teams and make recommendations to improve internal workflow processes globally
Assist with various special projects including sales research and analysis, proposal composition, newsletter editing, etc
Contribute to the development of new quality assessment policies and procedures
Bachelors Degree or equivalent
Extremely detail oriented with independent problem solving skills
A high sense of urgency coupled with the strong ability to multi-task
Propensity to effectively communicate and interact with senior managers
Experience editing/proofreading documents

Quality Specialist Resume Examples & Samples

Able to come up with test strategy, test plan and test cases for a given test requirement
Able to Estimate, prioritize, plan, and coordinate different testing activities
Able to lead/guide test automation efforts in the team using latest test framework using BDD
Able to perform white box and black box testing
Familiarize with different test techniques and methodologies
Experience working in Agile work environment
Provide technical guidance to the junior engineers in the team
BE, MCA degree or equivalent education with 8+ years experience in testing highly distributed, complex eCommerce platforms
Experience in testing different web service methodologies like REST over XML and Jason
At least 3+ years experience in automation using languages – JAVA or similar
Experience in white box testing and building testing frameworks
Experience in validating and certifying web services using Soap UI / TestNG / Cucumber etc tools
Hands-on experience working with relational database (Oracle, MySQL)

Quality Specialist Resume Examples & Samples

Drive the complaint investigation process to ensure quick response and minimal repeat complaints by detailed root cause analysis and initiating and executing CAPA
Ensure all incoming raw materials, packaging materials and finished goods are tested and released as per standards detailed in EPIC
Working with procurement to ensure all downstream suppliers can meet the required specifications
Drive the site quality improvement programme to meet customer service expectations, reducing complaints and build the TPM Quality pillar
Ensure the chemical safety and quality of new and transferred products into the site
Proven track record of working within a quality department, preferably within a sterile manufacturing environment
Degree in chemical engineering, chemistry or other sciences
Relevant healthcare experience in quality or process engineering where you have demonstrated the above skills

Quality Specialist Resume Examples & Samples

The Quality Specialist position requires a multi-skilled individual. This team member
Plans, organizes and directs Portfolio-wide quality initiatives
Performs internal audits
Organizes and manages customer audits and registrar audits
Provides training to Portfolio staff on all Quality System areas
Develops new process instructions and revises existing ones to improve the quality system
Manages the non-conformance process
Maintains required quality records and develops quality statistics
Gathers and reports KPI data for the Portfolio
Analyzes non-conformance and KPI data for trends, develops reports for management and initiates Continuous Improvement projects to improve processes
Ensures that the various Portfolio functions conform to the terms and conditions of the contract
Manages the interface between the Portfolio functions and the external customer's Quality Advisors
Provides Portfolio leadership with respect to integrating quality into the way it does business, to improve its performance
Initiates Continuous Improvement projects to both resolve Portfolio problem areas and to develop opportunities for improvement

Quality Specialist Resume Examples & Samples

Bachelor degree (B.A./B.S.), or equivalent experience, is required
Experience with Quality Management Systems (Change control, deviations, complaint management, CAPA, documentation management, among others), people management, Six Sigma, Lean, Practical Process Improvement (PPI), etc
Must have a sound understanding of cGMP’s and SOP’s
Must have understanding of validation, calibration, preventive maintenance, cleaning process, electronic records, among others
Must be familiar with EU and US GMP regulations

Quality Specialist Resume Examples & Samples

Five years experience in Quality Assurance/Regulatory Affairs
Knowledge of regulatory requirements including ISO 13485, FDA GMP and the IVD Directive
Associates Degree in a Biological Science w/ five years of relevant experience, Bachelors preferred
Excel skills
Positive leadership skills focusing on success and continuous improvement
Promotes and ensures safe working environment
Ability to manage multiple tasks and functions
Ability to communicate effectively across multiple department disciplines
Excellent communication and computer skills
Ability to read and understand governmental and advisory regulations

Quality Specialist Resume Examples & Samples

Drive data analysis of quality results from production and undertake trend analysis and root cause analysis
Drive implementation of corrective and preventive actions and monitor trends during implementation for effectiveness review
Support development/enhancement of quality and related management initiatives for enhancing global production performance
Drive root cause identifications and prepare analysis on the facts and drive systematic actions to reduce the Non- Conformities and/or continual improvements
Support the ICE (Issue Correction and Escalation) problem resolution process for production
Support/Lead/Drive/Mentor implementation of production/Quality management processes across teams and across departments

Quality Specialist Resume Examples & Samples

Post-secondary degree in Science, Engineering, Quality Assurance or other relevant discipline preferred or relevant experience
2+ years’ experience with Document Control. Experience in writing and controlling documents required
2+ years’ experience in Quality Systems, Quality Assurance or Regulatory Affairs. Experience in a Pharmaceutical or Device GMP /ISO Environment preferred (e.g. ISO 13485, ISO 9000)
Experience with medical device complaint handling and/or mandatory problem reporting an asset
Excellent organizational skills and ability to set priorities
Excellent written/verbal communication skills in English (French would be an asset) – particular emphasis on procedural writing skills
Strong analytical skills; ability to analyze spreadsheets and charts
Superior computer skills using MS Office and use of the Internet
Strong problem solving skills, ability to think creatively within established regulatory guidelines
Ability to interpret difficult situations and determine optimal solution(s) to ensure customer satisfaction
Experience in general office administration

Quality Specialist Resume Examples & Samples

Implement production, quality, and customer-service standards
Align and maintain the advanced material QMS with the corporate QMS
Lead the audit program
Support supplier management including, maintaining the contract manufacturing evaluation program
Provide direct customer support responding to customer requests and complaints
Oversee validation of quality processes through establishment of product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures
Developing quality assurance plans by identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and inventories
Provide valuable problem solving, project and change management abilities to lead or participate in continuous improvements in quality
A minimum of 3-5 years of experience within the Quality/technical/regulatory function in a medical device or pharmaceutical manufacturing facility
Manufacturing operations and laboratory experience preferred
Ideally, experience with cGMP internal and external quality auditing
Authorized to work in the US

Quality Specialist Resume Examples & Samples

Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Act as team member in supporting quality disciplines, decisions, and practices
Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues
Understands, interprets, and applies Documentation Control principles and processes to ensure compliance with Corporate, FDA, MDD, PAL, CMDCAS, ISO regulations and standards with unyielding integrity
Ensures awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Boston Scientific
Quaterly presentation to Country Leadership Team
Facilitation of Induction Training

Quality Specialist Resume Examples & Samples

Coordinates investigation, analysis, and responds to quality/patient safety issues, events, significant care issues or trends. Leads and/or facilitate root cause analysis, failure modes and effects analysis, and process improvement, working with multidisciplinary teams
Develops and analyzes data for administrative and clinical decision making, as well as regulatory requirements. Coordinates implementation of data collection processes: provide analysis, summary, research and benchmarking. Prepares and present reports for appropriate facility, system, and other external agencies. Provides oversight to projects including data abstracting and data entry as appropriate
Serves as a resource and leads and/or facilities task forces to plan, implement and coordinate facility activities to maximize service quality, effectiveness and efficiency. Collaborates with key stakeholders to evaluate, plan and implement process improvements and patient safety programs across the facility and/or system
Supports implementation of facility quality and patient safety goals, policies, procedures, and activities designed to meet the requirements of regulatory and accrediting agencies such as JCAHO, CMS, DHS, and the peer review organizations
Acts as consultant and educator in program development and special projects as determined by their supervisor
Participates in implementation of evidence-based practices at the facility or system level
May coordinate peer review activities for physicians and other healthcare providers and provide information for departmental improvement activities, credentialing, and reappointment
In some roles, this position may supervise professional staff

Quality Specialist Resume Examples & Samples

Validates and performs quality review of scanned records as well as monitors and maintains the integrity of the legal medical record
Determines readiness of batch for quality control process
Reviews the quality of all images in batch and verifies accuracy of the indices assigned
Identifies trends in scanning errors and processes and communicates to management
Relocates electronic images that are incorrectly filed in another document or encounter
Verifies readiness of batch for validation process
Assists with quality review of medical records as appropriate and determined by manager

Quality Specialist Resume Examples & Samples

University Degree with B. Sc
Pharmacy, Microbiology
3 to 5 years of relevant work experience in a GMP related industry/Quality Operations/Pharmaceutical applications
Strong understanding of Health Canada GMP, ISO 14644, Cleanroom practices, Narcotic Control Regulations (NCR), Food and Drug Regulations Part G (FDR), Benzodiazepines and Other Targeted Substances Regulations (BOTSR), Medical Device Regulations
3 to 5 years of relevant work experience in a GMP related industry/Quality operations/Pharmaceutical applications
Strong problem solving, critical thinking and analytical skills
Knowledge and application of computer systems for word processing, reporting, data analysis and complaints management
Ability to proactively initiate and implement continuous quality improvement
Excellent written/oral communication and organizational skills
Ability to work autonomously

Quality Specialist Resume Examples & Samples

Manage distribution of GMP documents (e.g. methods, procedures, logbooks…)
Generate monthly Key Quality Indicators (KQIs) related to documentation and training
Maintain the Microsoft SharePoints owned by the department
File and archive documents owned by QA (e.g. training records, GMP certificates, etc.)
Provide administrative support
Clarify simple deficiencies in GMP documents with the line unit experts in own responsibility
Collaborate with other associates to support the service function of QA
Participate in knowledge exchange in QA and associated line function
Quality standards are understood, designed into work activity, and achieved
In accordance with departmental objectives such as support of projects with agreed quality and delivery date, passing of internal and external inspections
Communication skills to sufficiently address GMP and logistic related questions with the line unit experts, in order to maintain GMP records in a compliant status
Knowledge and flexibility to work with relevant IT systems
Ability to analyze and evaluate GMP compliance
Technical and regulatory knowledge in a specific area
Basic knowledge of drug development

Quality Specialist Resume Examples & Samples

Conducts quality inspections of raw materials, and intermediate inspections as delegated
Conducts reviews of batch documentation for compliance for product release as delegated
Supports activities associated with aspects of the Quality Management System including
Advanced knowledge of QC, Manufacturing & Inventory processes
Working knowledge of QMS, QSR & ISO standards and requirements
Advanced knowledge of Microsoft Word, Excel and related functions including the formulation of graphs
Experience working with Electronic Quality Management Systems
Strong verbal and written communication skills are required
Degree level, preferably in a scientific discipline; or equivalent combination of education and experience
Previous experience in Quality Assurance in the Medical or Diagnostics Device industry
ERP experience strongly preferred

Quality Specialist Resume Examples & Samples

2+ years of administrative, quality, data analysis, or manufacturing experience
Experience supporting engineers or working with quality records
Experience working with electronic records databases (e.g. QADoc, D2, Agile)
Experience with analytics software (e.g. Spotfire, Business Objects)
Experience in a highly regulated industry, preferably implantable medical devices
Proficient in Microsoft Word, Excel, and Powerpoint including the use common editing practices such as tracking changes within documents

Quality Specialist Resume Examples & Samples

Solid PC skills (Microsoft Office – Excel, PowerPoint, Word, Outlook, etc.)
Strong communication (verbal and written) and interpersonal skills
3+ months related experience working in Tech Support preferred
6+ months project experience preferred
Outstanding analytical and problem-solving skills
Proactive, ability to use own initiative to take the lead to devise creative solutions
Works effectively in the face of ambiguity, shifting priorities and ensuring credibility is maintained through solid delivery against commitments
Fosters a culture to create a winning scenario for both the client and the business
Superb listening skills, leads and drives work and coaching in a partnership
Drives problem resolution using experience, in-depth related product and process knowledge and analytical skills
Uses sound judgment when making decisions on more complex issues
Effective planning, organizational and follow-up skills
Builds engagement and trust while helping to lead change
High energy, self-starter, strong performer, excellent team player
Exceptional leadership to work in a fast pace environment, own tasks and drive to timely completion
Clear sense of urgency and constructively deals with troubleshooting
Expertise in building rapport with diverse cross-functional teams and maintaining networking relationships
Ability to remain calm and objective in a high-pressure environment
Client centric, should demonstrate a commitment to quality and attention to detail

Quality Specialist Resume Examples & Samples

Quality review and release of Manufacturing DHRs for Reagents and Consumables
Ensure lots meet QC functional test requirements and acceptance criteria; review data provided by QC or R&D, as applicable, prior to product release
Release approved lots to inventory via materials resource tool (SAP)
Facilitate initiation, review and closure of nonconformance records (NCRs) associated with production lots, including evaluation and disposition activities as needed
Verify Process Deviations referenced in manufacturing batch records
Coordinate with Planning to ensure timely release, consistent with Packaging/Shipping schedules
Provide Good Documentation and Batch Record Review training and guidance to Manufacturing personnel and new hires, consistent with the approved work instructions
Ensure standard Manufacturing and Quality practices and procedures are followed
Update and revise procedures / work instructions as required
May include other duties as defined by the department Manager

Quality Specialist Resume Examples & Samples

Manage TPM’s as assigned from a Quality perspective
Prepare Quality/Technical Agreements to align with the legal contracts
Support a program/project management process to support quality and compliance initiatives at TPMs
Co-ordinate the check of regulatory filings by creating RIA and approving change requests generated for external manufacturing of drug products and API’s
Travel to off-site locations to ensure and aid the quality infrastructure and appropriate quality systems for alignment to QA Third Party Manufacturing Quality or Technical Agreements
Support the management of critical exception documents and CAPA and review with Quality manager prior to decisions for relevant TPM exception documents for impact on product quality, safety, efficacy and impact to the regulatory filing
Coordinate and support follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints
Prepare Annual Product Quality Reports to ensure accuracy, completeness, timeliness, and that trends are identified and addressed in an appropriate manner. Complete management reviews with assigned TPM’s that identify and address quality, operational, and organizational issues
Support TPM Quality Heads in providing quality and compliance support/advice for finished dosage form product manufacturing, packaging, and labelling to the TPM’s. Provide support for quality audits, initial site approvals
Provide technical expertise and hands-on service, utilization of systems and additional Mylan resources to support quality and compliance related activities that are deficient at the TPM
Comprehensive understanding of pharmaceutical manufacturing for finished dosage forms with proven experience in QA, Operations, or Technical Support in a pharmaceutical setting
Manufacturing related experience in some of the following areas: sterile, liquid, solids or API’s
Audit experience of suppliers in pharmaceutical industry
Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives
Capable of analysing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues

Quality Specialist Resume Examples & Samples

Records cataloging and retention, preparation of acceptance data packages, preparation of program related metrics and reports
Supports reviews of proposals, contracts, regulatory, program and customer requirements in the development of quality assurance plans
Collects data to support analysis of process data, metrics, models and flows to identify root cause of routine problems
Collects data to support research and analysis of performance reports to improve process capability
Collects data to support Quality source selection activity
Supports preparation for hardware, software and system level audits
Compiles data for material review disposition
Works under close supervision

Quality Specialist Resume Examples & Samples

Supervising the returned products Procedure at Rhenus 3PL and deciding final release and providing training to the Rhenus’ operators
Responsible Quarantine Area at Rhenus
Covering weekly on site audits and Process Qualification at Rhenus 3PL on THV and HVT kitting lines
Handling NCRs ,SCARs and documenting procedure steps
Assisting the reconciliation of the returned products to Rhenus for the EMEA FCAs
Operators’ training - 10%
Review on returns relevant docs, fixing missing points after communication with Customer Service , releasing returned products – 60%
Move stop shipments to Quarantine, creates order on Quarantine - 10%
Prepares relevant Quality docs like Quality inspections , NCRs , SCARs - 15%
Prepare sample orders - 5%
Techical school education or equivalent studies
2-3 years experience on a Quality regulated industry like Medical Device, Pharma on relevant position
Trainings on Good Distribution Practices
Fluent English Writen-Oral

Quality Specialist Resume Examples & Samples

Providing first level assessment of Auditor output in compliance with internal and external (clients) policies as required
Reviewing reports from all Global Audit queues within the appropriate SLA
Documenting the findings per report, recording specific errors and noting any recommendations for remedial actions required to improve Auditor accuracy
Investigating and documenting the validity of client concerns following the Audit escalation process and reporting findings to Audit Team Leads/Managers
Recommending improvements to Audit policies, processes and technology and configuration questions where applicable
Participating in client meetings and calibration sessions as required
Carrying out ad-hoc tasks such as collating own and QS team’s data and reporting details to QS Team Lead
Be aware of, and comply with, all corporate policies
Must have relevant CTE Audit experience to be in a position to carry out Reviews on assigned queues
Must not be under any performance or disciplinary proceedings
Must possess the following
Quality Specialist must agree to work scheduled rotations, including working on holidays, evening / night shifts as necessary
Quality Specialists must be able to work overtime in order to meet critical business objectives on service level, productivity, and quality

Quality Specialist Resume Examples & Samples

High interest in big data scenarios and modern data warehouse and data management technologies
Work in an agile development environment which requires the individual to be self-driven, take decisions independently and be flexible in order to cater to demand
Experience with databases and SQL (preferable with SAP HANA)
Experience in setting up/maintain/working with Hadoop
Experience in administrative activities for Git/Github
2+ years

Quality Specialist Resume Examples & Samples

� Daily monitoring the incident tracking system to coordinate with relevant people (developer, customer, partner .etc.. to analyze and resolve incident ticket
� Making meaningful and comprehensive reports as requested
� Responsible for analyzing test result and taking appropriate follow-up actions
� Proactively participate into quality controlling activity such as analyzing, define, implements and execute test suite/case/plan according to the quality and test strategy
� Able to coach teams (Senior) in terms of quality assurance and test related processes, methods and tools
� Contribute to the full development cycle
� University degree in Computer science or related field
� Years of experience in software quality: Controlling (QC) and Assurance (QA)
� Strong in analytical skill
� Good skill in Database (SQL, Transaction, distributed system .etc.)
� Good skill in Linux OS
� Experience in source control system and code review process tool like Git, Gerit
� Familiar with bug tracking system and automation tool like Bugzilla, Jenskin .etc…
� Skill in scripting language such as Python, Linux shell script, profiler is a big advantage
� A knack for debugging and analyzing complex problems
� Good in English is required (Daily working in cross-team environment)
� SAP HANA
� Using code profilers
� Distribution strategies for data
� Distributed systems
� Experience dealing with customers and handling customer issues

Quality Specialist Resume Examples & Samples

Able to define quality and test strategies for cloud and machine learning based products respecting defined process- and product standards
Analyzes, defines, implements and executes quality and test related activities according to quality and test strategy
Creates a detailed test design incl. test system landscape definition and product standards, prepares tests (customizing & master data), authors and executes manual and/or automated tests
Analyzes test results (issues) and takes appropriate follow-up actions
Is subject matter expert for teams in terms of quality assurance and test related processes, methods and tools
Initiates process or tool improvements
Has advanced knowledge about relevant product and process standards, important legal requirements as well as quality assurance and test related tools
Has proficient knowledge and technical competencies of relevant programming languages and related development tools and processes
Has good knowledge of software development life cycle and Quality Assurance methodologies
Ability to analyze complex integration issues
Ability to work in global teams with different time zones
Degree in Computer Science, Mathematics, Statistics, Operations Research or related field
Track record of driving quality assurance initiatives for cloud-based and machine-learning-based software products
Proficiency in testing large scale enterprise applications processing multi-terabyte datasets in distributed Linux/Unix environments
Experience with one or more of scripting and build automation tools (Ant, Perl, Shell, Python, Maven)
Experience with unit testing frameworks such as JUnit, nUnit, Xunit, Jasmine, etc
Experience with testing tools and technologies such as Cucumber, Selenium, Robot Framework, etc
Hands–on experience in API automation framework
Knowledge of XML, web services testing (REST or SOAP) is a big plus
Strong desire to overcome obstacles and make your work benefit SAP's customers
Excellent written and communication skills in English language

Quality Specialist Resume Examples & Samples

Hands –on experience in automation esp
Selenium webdriver,
API automation framework
Experience of one or more of scripting and build automation tools (Ant, Perl, Shell, Python, Maven) is a plus
Good knowledge of software development life cycle and Quality Assurance methodologies
Proven ability to develop, execute and maintain test plans and test cases
Experience in Non Functional Requirement testing like Security testing and performance testing is a plus
Must have been involved in software testing cycles with enterprise products
Good Team player, handle multi-tasking, work independently and integrate well with the teams
Agile experience and ability work in global scrum teams
4-7 years of software engineering or related experience
Quality and Software Engineering expertise according skill level
Business English: fluent
Bachelor or Master degree or equivalent education

Quality Specialist Resume Examples & Samples

Write and maintain tests utilizing basic scripting techniques
Fluent in Excel pivot table, charting, and basic macro writing
Demonstrates understanding of the different browser idiosyncrasies and how they can affect application behavior
Writes functional requirement documents to support new/changed functionality and works with stakeholders to obtain signoff
Develops test plans and test strategies
Collaborates with offshore testing teams in India
Complies with various process controls throughout the SDLC
Supports business and call center teams in understanding system functionality
Supports the production release process, which includes the ability to work late nights and extended hours approximately once a month
Plays an integral role in the entire software development lifecycle including participation in design sessions, defining functional requirements, working with development teams, testing, and preparing code for production deployment

Quality Specialist Resume Examples & Samples

Provides System Admin support of the legacy Patheon Quality Management System (QMS)
Provides SME support on new Quality Management System (QMS) projects
Leads global changes to existing legacy Patheon Quality Management System (QMS) (i.e. data fields, etc)
Coordinates with appropriate staff to assess the impact of changes / data field selection options in QMS on Metrics reporting
Authors corporate standards / policies / Guidelines / Templates / Work Instructions related to QMS
Develops and provides coaching / training / support for new Site rollouts of QMS
Provides QMS SME involvement when issues are escalated from the global community
Provides QMS assistance to Site Compliance prior to and during Regulatory and/or Client inspection and post inspection
2-4 years of Quality Assurance experience

Quality Specialist Resume Examples & Samples

Supervises the daily quality activities, ensuring timely and accurate data collection, follow up of issues and quality of work
Develops, implements and monitors quality departments policies and procedures; ensures they are in compliance with The Joint Commission, NCQA, CME, federal, state and local requirements
Assists in developing and revising QA monitors to meet accreditation/regulatory standards
Provides reports based on timely and accurate data collection, identifies trends and monitors issues
Monitors the budgets, researches variances, and identifies opportunities to reduce costs
Coordinates and facilities staff support to various committees (e.g., quality, accreditation) which includes agenda preparation and monitoring of outstanding issues. Coaches staff and ensures their competency
Develops, implements, coordinates, and evaluates the CME programs, credentialing and privileges for permanent or temporary physicians and allied health providers
Coordinates and prepares for CME, accreditation, licensing, and quality surveys/audits
Maintains and monitors the various quality databases which may include quality reviews, CME, credentials and privileges and provider profiles
Assists in preparation of educational materials and course objectives. Maintains link between medical staff affairs and quality improvement, risk management, continuing medical staff education
Minimum two (2) years of experience in quality improvement or accreditation required
Previous supervisory experience recommended

Quality Specialist Resume Examples & Samples

Promote the company’s quality policy statement
Provide quality interface and expertise between the company and its customers to proactively identify and anticipate their needs and expectations to ensure that they are understood and satisfied
Monitor, maintain and improve the current quality management system and ensure continuous improvement in all areas
Ensure compliance with the quality procedures company-wide
Develop and implement a Quality organisational structure capable of supporting the strategic initiatives of local plant and regional quality and lead the efforts to integrate the quality needs in to the development of short and long term improvement plans
Develop a thorough understanding of quality to all relevant colleagues as part of their personal development
Develop, analyse and publish statistical data and process/product specification to determine standards and proposed quality and reliability requirements for the finished product
Provide expertise in Quality Assurance and process improvement tools/methods
Support the management of performance and provide development opportunities to all within the team
Represent the company on all quality related issues
Responsible for the effectiveness and efficient running of the Quality Department
Ensuring the Quality Management System conforms to the latest ISO9001 standard – including acting as the company’s representative
Produce test certificates as required
Works with local management team to set coherent and aligned priorities and targets across the entire value chain, monitor progress, analyse Key Performance Indicators (KPI’s) and act on deviations from targets
Deploys the standard quality improvement approach (i.e. 4Q) within all areas of the local organization to continuously improve business practices and performance
Drives application and development of group-wide best practice frameworks across the entire value chain to embed a culture of excellence in operational performance
Ensures (with HR Manager support) that the area of responsibility is properly organized, staffed, skilled and directed. Guides, motivates and develops direct and indirect subordinates
Other duties may have to be undertaken which will be determined by the Company, taking in to account the current level of responsibilities, experience and capabilities

Quality Specialist Resume Examples & Samples

To execute all the activities related to data quality by performing sample check analysis
To prepare manual SLAs according to the defined deadlines
To prepare periodic internal/external reports/dashboards on quality of services provided

Quality Specialist Resume Examples & Samples

Responsible for the metrics and reporting associated with Complaint Management processes as assigned by region: complaint intake, investigation, trending and reporting, escalation, timeliness, and closure. Responsible to support complaint handling systems: identify and improve systems and processes
Identify unique or unusual issues or trends, report and escalate to QAS management
Investigate complaints, trends, and target/threshold breaches for periodic reporting and ad hoc requests
Create reports and present information in appropriate forums
Identify opportunities for improvement to drive timeliness / accuracy metrics in the complaint management process and linked processes

Quality Specialist Resume Examples & Samples

Responsible for Quality Management System
Bachelor engineering degree (a plus if in any biomedical field) or equivalent
Knowledge of GMPs, FDA – QSR and ISO regulations and standards, in particular ISO13485 and QSR
Knowledge of good warehousing practices, including ability to interface and manage an offsite warehouse provider
Knowledge of inventory control and cycle counting functions
Knowledge of surface, air, and international logistics procedures, suppliers, and transportation options
Up to 3 years related experience
Knowledge of informatics tools, as Microsoft Office and Outlook
Ability to write reports to meet department objectives
Ability to manage in a constantly changing environment

Quality Specialist Resume Examples & Samples

Requires sitting at a computer and the ability to perform repetitive tasks the majority of an 8-hour shift
Must have proficient data entry, and typing skills
Must have average filing skills

Quality Specialist Resume Examples & Samples

Responsible for conducting audits on defects received for metrics and provide consistent feedback to investigators. Reduce defects by driving process improvement efforts through audit findings
Provide training need analysis to Training team for individuals/team/site for improving knowledge gaps
Conduct regular knowledge checks on floor through process tests, huddles, etc. Conduct reviews for other reviewer and drive Calibrations efforts across sites
Drive Compliance Process: Conduct compliance audit for investigators and report to Management for corrective action
Projects & Kaizen: Drive initiatives through SOP/process/Tool changes along with GPO team. Drive projects on automation to reduce QA manual efforts and improve QA yields
Results & Accountability: Ensures that effective controls are developed and maintained across the organization. Strong commitment towards goals and outcomes and to ensure the completion within established time frames
Produce analyses and reports, write systems queries to gather data, perform data-mining and analysis to support programs as well as identify new metrics and opportunities for quality improvements
A bachelor’s degree or higher in a relevant field
Prior experience in QA function or as a QA role
Experience in working with databases, and SQL in a business environment
Analytical Mindset and ability to see the big picture
Prior experience working on Excel and MS Access (preferred)
Experience in e-commerce / on-line companies in fraud / risk control functions is preferred
Understanding of basis lean and six sigma methodology would be preferred

Quality Specialist Resume Examples & Samples

Provide quality representation, guidance, leadership, and direction to product development teams for both API and Drug Product
Provide technical expertise for product quality decisions and project team decisions
Interface with contract manufacturing organizations, oversight responsibilities include review of batch documentation, deviations, investigations, etc. up to and including product release
Work closely with QA Associates, to mentor, guide and support daily product activities
Provide back-up support to on-going QA operations as needed, e.g., review and approval of analytical methods validation and transfer activities
Review of regulatory documentation and submissions
Maintenance, management, and enhancement of quality systems to ensure they conform to Alkermes quality practices and international regulatory compliance requirements
Assure product disposition procedures and policies provide safe, pure and efficacious products
Lead and/or support investigations into variances and quality issues and are able to assure that proper changes are made to guarantee continued and consistent product quality
Identify and evaluate fundamental quality, technical and product development issues and provide leadership, strategic input, guidance and direction for functional areas of the business and partnerships
Participate in or lead QA Supplier Quality audit
Provide QA support for Quality System cross-functional team development activities such as TrackWise enhancements for Change Control, Deviations, Investigations, Product Complaints and Supplier Quality Management. Support implementation of new software systems for continuous improvement of current paper based systems
Participate in Quality Systems continuous improvement projects, for example creating and tools and best practices for the data integrity program on line, for example Global Labeling Artwork Management
Ten to fifteen years of experience in the quality function
Thorough knowledge of cGMP’s and pharmaceutical manufacturing requirements
Working knowledge of FDA and EU requirements and guidance documents
Broad quality experience, including manufacturing operations, API and drug product release, method development, method validation and transfer, QP release, process validation
Ability to work well on a team and as an individual contributor

Quality Specialist Resume Examples & Samples

Oversight and maintenance of Supplier Quality Management
Develop Standard Operating Procedures and other quality related documents
Lead regulatory and 3rd party inspections
Interact with site personnel to drive cGMP compliant culture
Develop metrics and other tools to measure Quality systems
SME level Participant in continuous improvement projects SQM and other global harmonization projects as required
Represent the group on all aspects of SQM to all levels within the organization
BS in scientific discipline or equivalent
12 years’ experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms
Certified Quality Auditor an advantage
Experience in development of quality systems
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve complex compliance issues
Ability to be influential across levels of the organization, to negotiate effectively across the ECQA group to ensure harmonized processes are robust

Quality Specialist Resume Examples & Samples

Manage or support the document control program as well as suggest and implement improvements to existing process
Support the training program as well as suggest and implement improvements to existing process
Perform trending analysis (Quality Metrics) on an as needed basis, including using statistical process control methods
May assist in the investigation and resolution of nonconforming events and CAPA projects
May assist in internal and external audits
Write and/or review documents
B.S. Degree in Molecular Biology or related field plus 4 years of industry experience; in vitro diagnostic or molecular reagent quality assurance preferred or
A.S./High School Diploma plus 8 years of industry experience; in vitro diagnostic or molecular reagent quality assurance preferred
3-5 years of direct work experience in QA, including all aspects of device/diagnostic quality systems
Experience with ISO 13485 and 21 CFR 820
An understanding of GDP, FDA Quality System Regulations, CLIA and/or ISO Standards (ISO 13485 and ISO 14971) is a plus
Quality engineering experience is a plus

Quality Specialist Resume Examples & Samples

Supporting the timely transfer of Safety, Health, Environmental and Regulatory Affairs data (needed for creating e.g., Safety Data Sheets, labels, Transport documents) in different software packages by
Assuring standard phrases used for creating SDS have correctly been assigned to finished products
Verifying whether regulatory data assigned to finished products are consistent, up-to-date and conform to the EU directives and regulations related to the classification, labelling and packaging of chemicals
Provide regulatory support to the European Regional Product Regulatory Compliance managers, Business Unit management and production services managers/specialists as required
Ensure EHS/product regulatory data in databases and bolt-on software packages are properly maintained, for all the hazard communication documents and focusing on the proper functioning of the labelling system
Monitor developments in European legislation related to the classification, labelling and packaging of dangerous substances and preparations to the transportation of hazardous materials and to packaging and packaging waste
Provide support on the “routine” product approval/registration processes, and work with the EHS Product Regulatory Compliance Manager EMEA on approval/registration related projects
Being a gate keeper in the REACH supply chain activities
Participate in preparing the to register REACH substances dossiers
Participate actively in the Site EHS program and the required EHS responsibilities
Master in chemistry (or equivalent experience)
Be fluent in English in writing and speaking
Have good computer skills on all Microsoft programs with the focus on Access database, excel and SAP
Knowledge in EU EHS regulations, including REACH and GHS/CLP
Knowledge of the bolt-on software used to create SDS ‘s, labels and transport documents
Six Sigma Discipline
Be curious to understand and to improve knowledge
Motivated, energetic and executed focus
Communicates messages clearly and concisely
View change positively and embrace it
We are looking for a temporary contract of 1 year, starting

Quality Specialist Resume Examples & Samples

Coordinate Quality Program implementation for HEE-I with particular emphasis on laboratory and survey project activities
Perform general quality and data verification reviews for technical reports and other deliverables
Provide recommendations for updates to the Quality Program Manual to address new or revised operations, changes in industry standard requirements, and ORAU/ORISE requirements. Coordinate controlled manual updates for the Quality Program, Survey Projects, and Laboratory Manuals and ensure required documentation is maintained. Review new and revised procedures for the HEE-I Survey & Lab manuals and ensure the Quality Program Manual supports ongoing, new, or revised operations
Take part in HEE-I audits and track status of external findings and observations. Ensure status is up to date in the HEE-I Quality Action Tracking System as well as the ORAU audit tracking system. Support HEE-I key performance indicator development and maintenance
Perform internal assessments of HEE-I operations
Perform updates to the Process Control Database trend chart limits
Maintain the HEE-I Quality Action Tracking System including entering items and monitoring status. Provide status reports to the Quality Manager
Work with ORAU record management staff, as needed, to meet all HEE-I and ORAU/ORISE requirements

Quality Specialist Resume Examples & Samples

Provide expert level quality management support services to enable effective decision making and delivery of sound quality business outcomes
Add value to the management system effectiveness through continual improvement of tools, techniques, deployment, etc
Provide direct support and assistance to project managers/ engineers in the preparation of project (quality) management plans/ work procedure/ ITPs/ forms, etc

Quality Specialist Resume Examples & Samples

A Bachelor’s Degree in science or related degree is preferred
Experience working in a pharmaceutical, analytical and packaging manufacturing facility is preferred
Pharmaceutical GMP regulatory knowledge base in US, European, and other countries is preferred
At least one year of Internal/External Audit Experience under GMP regulatory requirements is preferred
Clinical and Commercial experience is preferred
Experience with TrackWise, SharePoint and other software systems are preferred
Microsoft Computer skills are required including experience with Microsoft Word, Excel, Access, and PowerPoint
Strong Communication skills are required since this position includes frequent interaction with both internal and external contacts. The candidate must work well with others, and must consistently present a positive and professional demeanor during their daily interactions. Skill in working as part of a team and collaborating with colleagues is required
Strong Written Communication skills are required since this position requires the preparation and issuance of reports in support of the internal and external audit program. The candidate must be skilled in writing concise, logical, grammatically correct audit reports for distribution at both a site and global level
Strong Organizational Skills are required since the employee must be organized and detail-oriented for success in this multifunctional role
GMP compliance will.be required and the employee is required to be trained on all related GMP SOPs and must abide by the rules and regulations associated with the maintenance of these documents
Some travel, sometimes as much as one time per month, and on average ten of twelve months per year, will be required

Quality Specialist Resume Examples & Samples

Manage workflow of property preservation process
Conduct Quality reviews as required
Manage / understand default actions and their impact on Property Services functions
Ability to problem solve independently
Identify and propose solutions for trending and challenging issues
Facilitate escalated requests to vendor and/or investor
Ability to manage multiple assigned projects/tasks simultaneously
Ability to manage conflicting priorities and communicate what is at risk to management
Updating of Process/Procedures/Letters and departmental training documents
Coordinate resolution of concerns between cross functional areas within organization
Validate vendor took appropriate actions and in accordance with Investor, Insurer and Internal work standards
Effectively communicate with Management, Vendors, Legal, Compliance and team both verbally and in writing. Written and verbal communication should be clear, concise and professional
Perform other job duties as required

Quality Specialist Resume Examples & Samples

Review internal batch records and release product for sale in SAP
Act as a primary contact for internal manufacturing and packaging to assist in troubleshooting, and problem solving quality issues
Represent Quality & Compliance on task forces/committees/process improvement projects
Provide training/share expertise with colleagues to ensure quality processes are followed
Perform quality audits of production activities, including but not limited to Line Clearance checks and GEMBA walks
Provide approval of offline rework/inspection activity
Provide training on quality topics to Plant Operations personnel

Quality Specialist Resume Examples & Samples

Leads stakeholders in analysis of process data, metrics, models and flows to identify root cause of complex problems and development and implementation of preventive or corrective actions
Develops scope, schedule, plans and leads hardware, software and system level audits to determine compliance with quality management system standards, configuration assurance, related business, regulatory and customer requirements, and reports results to management
Works under minimal direction and makes tactical decisions
Reviews and buys-off on material shipped or transferred from the site
Understands and applies job practices, techniques, standards, principles, and concepts to both production flight hardware and in maintenance operations
MRB (Materials Review Board) and/or corrective action experience
Minimum of 1 year Work Order and Non Conformance tracking systems experience (e.g. Manufacturing Enterprise Systems (MES), System Application Processes (SAP), etc.)
Experience with gathering data and performing Root Cause Corrective Actions (RCCA)
Experience in problem solving and improvement projects
Minimum of 3 years Quality experience

Quality Specialist Resume Examples & Samples

Assists Quality Assurance manager with special projects
Organizes and conducts current good manufacturing practice training for plant personnel
Approves cGMP product on a daily basis
Works directly with QC Supervisor to approve re-classes/repacks, and segregated cGMP product
Monitors and audits activities of all departments with respect to cGMP and ISO 9001:2008
Maintains the product stability testing program
Administers the LIMS system and provides LIMS support to all departments
Acts as SAP expert for the Quality Assurance lab
Supports the Quality Assurance Supervisor in handling vendor audit concerns, chemical complaints and stability testing
Maintains off-standard product summary
Document and assists with complaint and failure investigation
Maintains the QA/QC intranet web page
Assists the Quality Assurance Supervisor in audit preparations
Notifies management of quality/compliance issues
Facilitates changes to SOPs, policies, training materials, and other documents
Provides training and instruction in safety procedures, ISO 9001:2008 standards, and current good manufacturing practices and LIMS
Provide support on selected, large-scope projects involving data collection and/or research small scope individual topics drafting recommendations to QA management
Interfaces with other groups in problem resolution, and continual improvement
Participates in Safety and Environmental initiatives that will contribute to compliance of State/Federal regulations and improve existing Company programs
Maintains off-standard product summary and conducts periodic review with production management
Supports in handling vendor audit concerns, chemical complaints and stability testing
Document and assists with complaint and failure investigation, maintains databases and charts results
This position is located in Texas City, TX
This job is based on a ladder structure and the job level (salary) will be determined by the quantity and quality of your experience

Quality Specialist Resume Examples & Samples

Function as Quality Technical Lead with special responsibility for projects relating to computerised system and process automation control systems
Function as Quality Technical Lead on projects relating to facility, utility and equipment changes/upgrades in line with strategic objectives
Serve as Quality Technical lead for qualification/validation based activities to support the above in line with current guidance and site/global procedures
Participate in and support risk management activities in line with relevant guidance and best industry practice
Provide input and guidance to deviation management activities resulting in appropriate root cause analysis and relevant CAPA actions
Provide leadership, guidance and support to data integrity initiatives and systems
Evaluate new and prospective Regulatory guidance and industry best practice and determine impact on current Quality systems, identifying and implementing appropriate updates where required
Build collaborative relationships within and across the business to ensure critical path deliverables are achieved
Challenge practices and procedures in current area of expertise, offering new ideas and/or solutions to enhance performance within the function/site
Participate and/or lead internal and external audits in order to maintain existing Quality standards and facilitate continuous improvements
Ensure adherence with best health and safety practices

Quality Specialist Resume Examples & Samples

Autonomy, Responsibility and Authority Works to agreed objectives. Has full responsibility for quality of work performed by the Operations Team
Complexity of Work Performs work which requires the application of a significant range of fundamental principles in a wide and often unpredictable variety of contexts
Essential Skills Demonstrates Problem analysis skills. Demonstrates effective communication, both orally and in writing, with subordinates, colleagues, clients and customers at all levels, both formally and informally. Should be able to liaise with the Service Desk operations on critical Quality Assurance requirements and functions
Knowledge and Scope of Expertise Demonstrates a good understanding of the relationship of own specialization or area of responsibility to the employing organization as a whole and takes customer requirements fully into account when making proposals and/or carrying out work
Learning and Development Takes initiative to ensure technical or specialized skills and specializations are kept up to date in line with industry developments

Quality Specialist Resume Examples & Samples

Establish lean practices for
Complaint Handling
Training Administration
Practices include the necessary tools: QMS software, processes, competency and process performance
Initiate, evaluate and ensure complaints are resolved, initiate CAPAs, analyze complaint data, gather additional data as needed, and provide feedback to the development teams on potential product improvements, product defects, and safety evaluations
Evaluate customer feedback, service records, and other sources of customer and internal data for possible complaints
Control & maintain the document management system for issuance recording / filing, tracking, retrieval of documents like procedures, plans, QA records, specifications and related documents
Establish Document Control support to authors and (local) process owners in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records
Ensure all mandatory training requirements are set and controlled and training is executed as required
In close cooperation with mangers ensure the assignment of the correct training profiles to all individual employees based on job requirement profiles
Administer both profiles and training records in line with requirements and support users on using the Training Management System
Establish, monitor and respond to metrics on the efficacy and efficiency of the document management, complaint handling, and training management systems and their ability to support the business
Collect relevant QMS data from various sources for Quality Monitoring
Actively promote a quality and regulatory compliance culture throughout the organization
BA/BS degree required
3 to 5 years related experience working in the quality function for a Medical Device or regulated company
Experience working with QMS Software tools
Experience running effective process improvement projects
Knowledge of ISO standards for Quality Management Systems
Preferred Qualifications
6 Sigma/ LEAN certification preferred
Procedural or Technical writing experience

Quality Specialist Resume Examples & Samples

Ensuring all accommodations are compliant with CTE allowable costs and policies
Interacting with travel vendors to book and/or re-route trips as necessary
Calculating and comparing costs for travel
Provide travel cost analysis
Obtaining appropriate approvals
Ensuring proper documentation for expenses is received
Supporting travelers during normal business hours

Quality Specialist Resume Examples & Samples

Provide a fundamental leadership role and act as a SME & coach as needed for the following responsibilities
Leadership Roles
Experience with active roles during Audits or Regulatory Inspections
Ability to prepare high quality presentations and speak, present data, and defend approaches in front of audiences, including BioMarin Management or inspectors
Organizational skills to contribute to cross-functional projects
Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications including TrackWise, CMMS, LIMS, SCADA etc

Quality Specialist Resume Examples & Samples

Provide in-process inspections and monitoring, analyzing the quality of manufacturing processes and products
Perform product reviews and analysis to determine cause and/or disposition
Provide audit support in designated areas
Use measuring tools and equipment to verify dimensional and functional requirements
Participate in problem solving events as needed
Assist with data collection and analysis
Provide special project support to quality engineering team
Facilitates problem solving / process improvement efforts within unit
Lead and/or assist in the calibration of inspection, test, and measurement equipment
Assist with training personnel to adhere to quality standards
Participate in lean activities as required
Observe all applicable safety rules and reporting any unsafe conditions or potential safety hazards
Knowledge of Pentair product design and manufacturing processes preferred
Knowledge in technical aspects of products as well as of product specifications and offerings
Skills to quickly learn and operate a wide variety of test and measurement equipment
Knowledge of brazing, tig welding, machining, and/or testing an asset
Experience in MS Office applications (Word, Excel, etc.)
Skill in identifying root causes of routine problems/issues and the ability to develop recommendations for resolution
Ability to use precision measuring equipment (e.g., micrometer, paint mil gauges, etc.), and computer terminal
Ability to operate hand tools (precision measurements tools)
Ability be able to interpret drawings and draw conclusions
Ability to stand and walk frequently
Ability to utilize good written and verbal communication skills, with the ability to interface with people across multiple functional areas within the company
Ability to effectively organize, plan workload and work in a self-directed manner
Ability to build and maintain effective work relationships across functional areas
Ability to adapt to a rapidly changing business circumstances and have the ability to thrive in a constantly changing business environment
Ability to work primarily indoors where there is frequently noise of 85 dBa and occasional exposure to chemical hazards (solvents)
Bachelor's degree or two-year technical college diploma preferred. Equivalent experience may also be considered
Ideally at least six months quality process experience
Ideally at least one year experience using metal fabrication measurement tools/techniques

Quality Specialist Resume Examples & Samples

Automate manual test cases, from both UI level and API level, investigate failed automation test cases
Seek for better automation tools, or even develop our own framework to achieve automation test for different kind of applications
Work well in close teamwork over different projects
3+ years’ experience in software testing, including designing and implementing complex test plans. Web-based testing a plus
2+ years’ development or test automation experience

Quality Specialist Resume Examples & Samples

Creation and execution of manual and automated test cases for functional, regression and end to end testing, including API, database and front-end testing of the entire system, subsystems and interfaces to other systems
Maintain test data, test cases and support Jira bug tracking
Participate in functional and technical requirements discussions with Product Managers, Product Owners and User Experience teams

Quality Specialist Resume Examples & Samples

Creates manual test cases (conducts them from specifications, design, etc.) besides other parties
Prepares the test environment (MIT, AT, SIT)
Carries out manual and automated tests
Automates manual tests
Regularly carries out automated tests
Delivers documented test packages in test workbench (with indication of status); internal incidents to point out mistakes; Manual and automated test cases; Test report
Learn quickly
Good knowledge onCloud and OnPremise solutions
Good communication skills in English are essential, as you will work in an international team
Self-reliant and teamwork-oriented individual
Minimum one year of experience in quality assurance position

Quality Specialist Resume Examples & Samples

Provide support for Quality Systems and maintain the appropriate level of customer service. Has the ability to write clear, coherent internal business communications / reports. Formally presents results of work
Non Conformance Reports and monitoring reporting performance and trends
Problem solve, identification of root cause and implementation / follow up of corrective procedures and preventive actions to ensure timely resolution of such problems
Ability to perform internal audits as required according to site and global plans
Use auditing as a proactive tool for improvement as well as compliance and challenge existing practice where appropriate
Measuring and monitoring of performance against agreed KPIs
Actively participate and/or drives EU/Global QMS improvements as required
Quality Assurance / Auditing experience in a chemical, pharma or manufacturing industry
Experience in the one of the following - training, validation, problem solving tools. Understanding of statistics based management & procedure is preferred
Excellent MS Office skills in particular Excel (Trackwise and Statistical Software or comparable experience)
Ability to perform routine duties with minimum supervision

Quality Specialist Resume Examples & Samples

Create quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product quality
Create and implement projects for quality improvement
Collect, analyze, and present Quality data
Actively partner with Manufacturing departments to provide Quality Assurance support
Investigate, analyze and correct process non-conformances (internal, external and systemic issues)
Lead root cause analysis, implement/provide corrective actions and ensure their effectiveness
Create, maintain and evaluate product/process trends, designing and/or participating in process and product improvement plans
Participate as internal auditor, and participate in external audits
Participate actively in Continuous Improvement programs
Other duties may be assigned, as required
Travel requirement: 0-10%
BS in Chemistry, Biology, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or BS with other demonstrated equivalent work experience in the Quality Systems area pertaining to a scientific industry
Strong computer skills (MS Word, MS Excel, MS PowerPoint)
Knowledge of Operations and manufacturing processes
Familiarity with enterprise software systems including Agile, TrackWise®, SAP-LMS
Able to motivate and positively influence peers
Ability to resolve rapidly common inquiries or complaints from internal and/or external customers and regulatory agencies
Ability to effectively present information to groups of employees, site leadership, and customers
Ability to read, analyze, and interpret common scientific data and QMS standards

Quality Specialist Resume Examples & Samples

Applies current Good Manufacturing Principles (cGMP) in all areas of responsibility
Responsible for maintaining the Supplier Quality Management program
Responsible for Change Control system (TrackWise)
Responsible for coordinating and executing the Internal Audit program
Assists with and follows-up on non-conformances, investigations, complaints, etc
Assures that issues are resolved in a timely manner and corrective actions/preventive actions (CAPA) are implemented and monitors effectiveness to prevent reoccurrence
Evaluates and develops techniques designed to maintain awareness of SOP’s, cGMP’s and clinical requirements
Extensively interacts with direct functional teams (Operations, Client Services, etc.) to resolve quality issues
Supports and assists on regulatory and client audits
Demonstrates and promotes the company vision
Bachelor degree (B.A./B.S.) is strongly preferred
2-5 years Quality Assurance/ Quality Control experience in a cGMP environment
Previous experience in the Pharmaceutical, Medical Device, and/or Biotechnology industries
Experience with Quality Management Systems (Change control, deviations, complaint management, CAPA, documentation management, supplier quality, internal audits)
Understanding of Six Sigma, Lean, Practical Process Improvement (PPI), etc
Possess strong written, verbal and interpersonal communication skills and work independently as well as in close collaboration with others
Demonstrated attention to detail and ability to solve problems and communicate issues
Ability to work on multiple projects with competing deadlines
Willingness to travel 10-20%

Quality Specialist Resume Examples & Samples

Bachelor’s degree or Engineering Diploma (3 years college/polytechnic education)
Relevant work experience of 2 to 5 years (or equivalent combination of advanced education and relevant work experience)
Demonstrable training/certification/usage of quality systems, relevant methodologies, and/or project management processes

Quality Specialist Resume Examples & Samples

Work with internal and external customers to obtain and in depth understanding of roles, processes and documentation specifications and requirements
Review documentation on a regular basis to ensure all changes are made and all documentation are current and valuable
Meet with Lane Business Owners to gather Audit Points and create valuable and beneficial Process Audits, along with reviewing the Audits regularly to ensure they are still valuable
Assist in gathering pertinent data and analyzing this data to support project or quality initiatives
Explain in overarching documentation, or detailed job aides, Technical and Pharmacy Practice processes, policies and guidelines
Produce high quality documentation that contributes to the overall success throughout the Pharmacies
Study and understand work flows to be able to update, and create, documentation
Support Project initiatives by executing on Quality Plans which include Documentation, Process Audits, Change Management and Training for changes
Develop and drive best defined practices within each team around the foundational blocks of quality, including but not limited to, documentation and process audits
Revision of any documentation as new issues and/or changes arise, as well as utilize screen shots, drawings, diagrams, animation and charts to increase and simplify users understanding
Being able to conduct comprehensive presentations to all levels of management

Quality Specialist Resume Examples & Samples

Function in a liaison capacity, combining business planning expertise, to analyze and translate business requirements into system deployments and/or business process changes
Consults with business owners to identify, define and gather business needs and objectives, current procedures, issues, input/output requirements and levels of access
Works with departmental end users, technical analysts, informational technology analysts, consultants, as well as other parties in the analysis, design, configuration, testing and maintenance of systems/processes to ensure optimal performance
Analyze the feasibility of, and develops requirements for, new systems/processes and enhancements to existing systems/processes, to ensure the needs of the users are met
Act as a change agent, to help facilitate effective deployments/modifications, to current practices
Identifies opportunities for improving business processes through information systems and/or non system driver changes
Assists in the preparation of proposals to develop new systems and or process changes
Researches and prepares statistical reports utilizing data to consolidate information into cohesive and understandable information for use in management decision making
Conduct Change Impact Analysis to assess the potential implications of change and documents business rules, functions, and requirements
Participates in user acceptance testing and testing of new process or systems functionality
Understanding of process engineer concepts (Six Sigma Yellow/White Belt)
The ability to conduct cost/benefit analysis and business case development
Deliver effective solutions to complex business challenges
CBAP Certification
Strong Knowledge of Microsoft Office Suite (Excel, Word, PowerPoint, Visio, Access) and Pharmacy Practice
BA Degree or (2) years of Pharmacy experience

Quality Specialist Resume Examples & Samples

Support and coordinate MRB activities
Support Production operations Quality
Perform investigations for NCR’s and CAPA’s
Perform investigations
Make Quality system changes/improvements
Assist with calibrations
Track and trend Quality data
BS degree in Science or Engineering preferred
1-2 years of Quality experience, preferably in a Class II or III medical device environment
Proficient in standard office tools, including Excel, Access, Word and Power Point. Good oral, written communication and teamwork skills

Quality Specialist Resume Examples & Samples

Participate in Product Problem Meetings relating to complaints and product problems to identify if issues need to be reviewed for Safety Board action
Review RMD Potentially Reportable Incidents (PRI), in conjunction with applicable RD functional areas, for Adverse Event Reporting. Prepare and submit Adverse Event Reports, including Biological Product Deviation Reports, for RMD PRIs that require reporting
Prepare Safety Board Situational Analysis and Health Hazard Evaluations, in anticipation of Safety Board meetings. Subsequent to meetings, prepare or coordinate official Safety Board notices and field correction and product removal documentation as per regulatory requirements
Respond to Affiliate and/or Regulatory agency request for information pertaining to Adverse Event Reports, Field actions, product removals, and any other product compliance/safety risk
Review Quality Notifications and evaluate whether the issues presented require a Health Hazard Evaluation or additional escalation to Quality Management
Support audits and inspections
Maintain post market surveillance activities associated with the OEM and Private Label Manufacturer relationship between RMD and CPS

Quality Specialist Resume Examples & Samples

Perform Quality Audits & Report on QA results
Conduct process adherence based audits identifying process deviations and best practices
Share Audit feedback with Investigators/Team managers. highlighting low, mid and focus areas where applicable
Provide coaching tips and training suggestions to managers for targeted areas for improvement
Produce daily, weekly and monthly analyses and reports on process adherence trends and deviation root causes at investigator, team and site levels
Excellent written and spoken German and English skills with an ability to compose grammatically correct, concise and accurate written responses
Familiar with sampling methodologies to ensure the correct number of investigation audits are performed
A firm understanding of processes at either a local or cross – functional level and associated
Have basic knowledge of MS SharePoint/SQL to fetch the data needed for analysing and avoid dependency
Have deep knowledge of Excel and experience in working with databases
Prior experience working in a regulated environment with a proven track record of strong performance and leadership
Have a proven track record of exceeding decision quality goals in a fraud/risk investigations role
Language proficient applicable to function requirements
A basic knowledge of Quality Audit methodologies and tools
Prior experience in quality auditing/coaching and development
Understanding of specific function process, Tools / SOPs
Experience of participating in Kaizen / Process Improvements events

Quality Specialist Resume Examples & Samples

Implement and monitor quality assurance policies and procedures
Plan and conduct and document internal office quality audits
Investigate non-conformance issues

Quality Specialist Resume Examples & Samples

Identify the functional areas which are not covered in testing & build test cases around those areas
Translate detailed functional requirements and technical documentation into test plans and test cases
Write and develop test cases based on real time business scenarios for SAP Integration
Participate in requirement and design reviews & provide vital inputs
Debug issues encountered & provide quick but appropriate solutions
Propose for enhancements in the existing features & functionalities
Provide regular reports on test status, and risk assessments on product quality and features
4-6 years strong functional experience in SAP FI Modules
Working knowledge of the SAP programming language ABAP is highly preferred
Should be well versed with Procure to Pay Cycle process & should have strong procurement domain experience
Good working knowledge of middleware like SAP PI is definite plus
Self-driven, independent & should be able to work with minimal supervision

100

Quality Specialist Resume Examples & Samples

Strong focus on quality and generating results
Exceptional time management and organization
Must have strong automation skills
Must have experience in QA testing/methodology
Experience with automating tests (api, library, backend and UI) and frameworks for web, mobile or services platforms
Knowledge of CRM is a plus
Proven technical achievement as an individual contributor
Excellent automation skills with SAHI
Experience in testing SaaS (Software as a service) On-Demand enterprise solutions
Excellent troubleshooting skills and ability to communicate detailed technical analysis

101

Quality Specialist Resume Examples & Samples

Performing quality control checks by reviewing mortgage documents (note, mortgage, title policy, assignment, modification, etc.) for specific data and document elements,
Validating data in the custodial system. They will utilize a database tracking system to perform data entry and quality reviews to minimize the impact of rework through early detection of errors
They will assist with monitoring workflow activities to help identify best practices and assist with suggestions related to process improvements
Work under direct supervision while performing job duties
Apply policies, procedures and guidelines to help identify process improvements. Work with limited supervision while performing job duties
May support an expansive array of mortgage products and services

102

Quality Specialist Resume Examples & Samples

Responsible for the creation, execution and validation of test scripts to insure all VRU enhancements go into production error free and on time
Testing includes both the UAT and production validation phases of a project
Supports trouble ticket resolution and the training of new and borrowed testers
Review and understand VRU project requirements, ensuring the expected result matches the project requirements with the goal to meet the published timelines and delivering a positive customer experience
Proof read and edit test plan and test scripts for various projects
Report defects to the proper group
Collect and condition test accounts to send to the Vendor on various projects
Make test calls for specific projects assigned (Small – Extra Large project sizes)
Attend project calls with the testing team, analyst, IT and Business
Provide production testing support for Sunday Major and Minor Host Release’s (8 a year)
Provide production testing support for monthly Project/TCR Installs
Provide call examples for production Tickets/Fixes/Issue
Upload test and production call logs to SharePoint site securely
Previous or current VRU testing experience, preferred
Knowledge of the host systems: IBS, FDR, Citilink or CitiSmart, preferred
Knowledge of the various applications and platforms, including Bankcard, Business Card, Collections, Sears, Oil, Home Depot, Retail, Mortgage, Second Mortgage or ReRecovery
Ability to review and understand VRU project requirements
Ability to work independently, manage multiple projects at one time and have a strong sense of attention to detail
Working knowledge of Citi policies and procedures
Experience with direct customer contact in one or more of the Sales, Servicing or Collections business units
Experience with MS Office Products: Outlook, Word, Excel and SharePoint

103

Quality Specialist Resume Examples & Samples

Ensure that a local FAC process is in place
Coordinate local activities in case of necessary FCAs (e.g. Blocking of stock, Perform batch tracking)
Assist responsible person in the assessment of retuned products
Review of documentation from customer and external warehouse
Assessment of avaiable temperature date
Experience in QA of a Marketing & Sales organization
Experience interfacing with regulatory bodies directly
Solves problems whilst maintaining Quality Standards and considering Shire Policy
Understands total potential impact and contributes to the solution of issues arising
Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently
Offers constructive comments and proposes improvements and rationalizations to systems, policies and procedures

104

Quality Specialist Resume Examples & Samples

SupportQuality Control Manager to develop and implement local quality control process
Developing yearly quality control process within CSU
Risk identification and assessment through data review and quality control processes (in-house documents review, on-site quality visit)
Providing support in risk mitigation and planning corrective/preventive actions/guidance for improvement
Contributeto the development and implementation of Study Risk Management Plan, monitor the implementation and delivery
Workclosely with monitoring teams to manage non-compliance and quality issues; assist in planning corrective/preventive actions, as applicable
Leadthe Pre-approval Inspection activities and act as the main contact person with quality team

105

Quality Specialist Resume Examples & Samples

Proficient Sharepoint and Excel knowledge as well as general PC Skills
Independent thought/objectivity
Prior audit or quality control experience

106

Quality Specialist Resume Examples & Samples

Ensure accurate documentation of evaluation and investigation results with the assigned complaint records
Collaborate with Engineering, Customer Support, Field personnel, Market Service Order reviewers and other appropriate groups for adequate initial evaluation of complaints
Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings
Coordinate with the reportable complaint investigators in providing any missing information for root cause activities
Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data gets pushed to the appropriate departments for actions
Support reviews and audits assigned
Work with the Post Market Surveillance Manager for any other projects assigned

107

Quality Specialist Resume Examples & Samples

Learns cGMPs, the manufacturing process, and Merck quality systems
Performs review of process documents/log books to ensure completeness and accuracy for assigned IPT. Maintains any tracking databases and logs associated with this review
Completes training to be a qualified auditor and completes monthly internal quality audits of the manufacturing areas in the IPT
Performs Quality review of new and updated Master Batch Records (MBRs)
Provides coaching and mentoring of manufacturing managers and operators completing documentation
Assists with training of incoming personnel
Cross trains to support other functional quality areas including but not limited to deviation management, environmental monitoring investigations, and inspection support
Completes training and is qualified to review qualification documents and change requests
Education Minimum Requirement

108

Quality Specialist Resume Examples & Samples

Complete supplier quality audits to a high standard and accurately report the results
Works closely with the Purchasing Quality Assurance (QA) teams and any other internal customers to maintain quality systems and industry standards
Working with suppliers on understanding customer quality plans and QRD’s
Execute internal and external corrective action and preventive actions (CAPA) processes within the structured continuous process improvement
Generate and interpret analytical data
Will supervise the creation and implementation of supplier development projects
Participate in monthly MCAB meetings
High School Diploma or GED with 4+ years of experience developing and executing customer quality plans
Strong SAP experience
Previous experience interfacing directly with customers/clients
Able to effectively collaborate with others
Understanding of business processes, industry standards and BHI technologies
Familiar with MS Office
Quality Engineering background
Previous internal/external audit experience
Associates degree or Bachelor’s degree
Lean Six Sigma, or other Root Cause Analysis training/experience
Develop, set-up and maintain calibration systems, quality control systems and tests
Previous experience in presenting detailed, technical information
Skills in quality control and calibration, business process modeling and SAP

109

Quality Specialist Resume Examples & Samples

Acts as a resource and advisor to team through various forms of monitoring to help ensure agents are adhering to policies and procedures, help insure correction and prevent quality slippage, to identify trends, gaps, opportunity for process improvement and additional needs
Works independently and within a team on special non-reoccurring and ongoing projects
Acts as Project Coordinator for special projects, at the request of the HR Service Center Manager, which may include: planning and coordinating multiple presentations, disseminating information, coordinating direct mailings, creating brochures
Acts as a liaison with other departments and outside agencies, handles confidential and non-routine information
Performs diversified and specialized administrative work for site leadership or functional unit staff
Coordinates or prepares HR Shared Services yearly operational budget
Coordinates travel, including air, hotel and car rentals as well as processing expense reports
Arranges meetings, luncheons and seminars
Provides Supervisors and Managers with regular agent performance feedback and trends, including preparing and analyzing monthly agent quality reports for Management review
Assists the Senior HRSC Optimization Analyst with troubleshooting, reporting, tracking, and ensuring resolution of technology issues
Responsible for ordering office supplies and other miscellaneous purchases, keeping supply room stocked and organized
Prepares agendas, transcribes and distributes minutes of meetings, electronically files and maintains those
Sets up and maintains complex electronic and paper filing systems
Five (5) years of Administrative/Secretarial experience
Strong knowledge of Service Center processes and techniques
Knowledge of office management/administrative support practices and procedures
Proficient in Word, Excel, and PowerPoint for presentations and reports required
Knowledge of basic accounting, budgeting or business practices and methods
Professional demeanor, dependable and able to maintain confidential information
Strong written communication skills (excellent grammar, spelling and sentence construction); strong multi-tasking skills
Must exhibit excellent leadership and interpersonal skills
Must be able to effectively communicate with agents, internal departments, management and customers/vendors of diverse populations
Demonstrated ability to rapidly gain process/procedural knowledge and effectively communicate it to agents
Flexible, detailed and able to successfully adapt to change
Excellent attention to detail and collaboration skills
Skilled in preparing and maintaining accurate records, reports and files
Ability to handle and prioritize multiple projects
Excellent organizational skills and ability to prioritize tasks and workload
Demonstrated ability to successfully complete delegated projects of some complexity with minimal supervision
Sound judgment and decision making skills
Must be able to work in a potentially stressful environment
Position is in busy, non-smoking office located in downtown Phoenix, AZ
Location requires mobility in an office environment; each floor is accessible by elevator
Occasionally work will be performed in a mine, outdoor or manufacturing plant setting
Ability to develop and maintain awareness of occupational hazards and safety precautions
Skilled in following safety practices and recognizing hazards
Must be able to frequently sit and stand; occasionally walk, bend, squat, climb, reach and kneel
Must be able to frequently lift and carry up to ten (10) pounds and occasionally lift and carry up to twenty-five (25) pounds
Must be able to operate and pull or push dollies, basket carts to retrieve, review and/or transport documents, files, boxes and other items
Ability to work with general office equipment such as a personal computer and keyboard, calculator, facsimile machines and photocopier
Personal protective equipment is required when performing work in a mine, outdoor, manufacturing or plant environment, including hard hat, hearing protection, safety glasses, safety footwear, and as needed, respirator, rubber steel-toe boots, protective clothing, gloves and any other protective equipment as required
Freeport-McMoRan promotes a drug/alcohol-free work environment through the use of mandatory pre-employment drug testing and on-going random drug testing as allowed by applicable State laws
Site-based positions, or positions which require unescorted access to site-based operational areas, which are held by employees who are required to receive MSHA, OSHA, DOT, HAZWOPER and/or Hazard Recognition Training; or
Positions which Freeport-McMoRan has designated as safety sensitive positions in the applicable job or position description and which upon further review continue to be designated as safety-sensitive based on an individualized assessment of the actual duties performed by a specifically identified employee

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Quality Specialist Resume Examples & Samples

Must be 12 months in tenure
Must have at least 3 rating for the last APR Cycle or must have at least an average of 3.6 for the last (4) quarters with no rating below 3.0
Must not have incurred NDA/Remedial Action Plan (RAP) for the last 6 months

111

Quality Specialist Resume Examples & Samples

Associate’s or Bachelor’s Degree in Business Administration or related filed
Prior experience working Medicare Grievances and Appeals
Proficiency with Microsoft Word and Excel
Knowledge in CMS Managed Care Manuals (Medicare Regulations)
Excellent written and communication skills both in English and Spanish
Ability to meet deadlines and on multiple tasks
Ability to work under pressure with minimum supervision
Strong collaboration and relationship building skills
Bilingual - English/Spanish -
Comprehensive knowledge of claims processes and customer service standards
Experience with the Claims Administration System (CAS)
Quality Experience

112

Quality Specialist Resume Examples & Samples

Provide quality representation, guidance, leadership, and direction to product development teams for Biological and Chemical API and Drug Product
Provide back-up support to on-going QA operations as needed, e.g. review and approval of analytical methods validation and transfer activities
Provide QA support for Quality System cross-functional team development activities such as TrackWise enhancements for Change Control, Deviations, Investigations, and Supplier Quality Management. Support implementation of new software systems for continuous improvement of current paper based systems
Participate in Quality Systems continuous improvement projects,
Broad quality experience, including biologic and chemical drug manufacturing operations, API, and drug product release, method development, method validation and transfer, QP release, and process validation

113

Quality Specialist Resume Examples & Samples

Conduct Quality Control support Clinical Assistant Team tracking
Assists the Quality and Accreditation Advisor with reporting metrics
Performs periodic audits of processes and data sets
Business support for IT Issue resolution
Actively participate in IT release user acceptance testing for the clinical documentation system
Acquire and maintain expert knowledge of MTM Program and clinical database system
Assist in quality control analysis to ensure client satisfaction and performance guarantees are met and/or exceeded

114

Quality Specialist Resume Examples & Samples

Reporting compliance status data to operational quality management
Collaborate with center management in the development and implementation of continuous improvement plans
Collaborate with Assistant Quality Manager (AQM), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns
Responsible for coordinating and managing training activities, policies and processes at the center level
1 In compliance with SOPs, performs all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect
2 In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process
3 Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor
4 May educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally
5 Maintains alertness to any reaction by donors and assists with reactions or notifies appropriate staff
6 Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events
7 Required to perform calibrations and verify that maintenance has been performed as outlined in the SOPs. Required to respond to and resolve complex equipment alarms or donor issues
8 Troubleshoots equipment failures. Creates incident documentation, removes and/or replaces equipment from service
9 Monitors donor flow on the donor floor to assure continuous turnover. Alerts Group Leader of Supervisor of donor flow issues
10 Collects arm samples or whole blood samples from donors for testing
11 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs)
12 Understands the policies and procedures associated with hyper immune programs at the center if applicable
13 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions
14 Maintains confidentiality of all personnel, donor and center information
15 May be cross-trained in other areas to meet the needs of the business
16 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business
17 Perform other job-related duties as assigned
Minimum twelve (12) months experience in a medical or health care environment preferred or equivalent combination of education and experience

115

Quality Specialist Resume Examples & Samples

1 Ensure center is “inspection ready” at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center
10 Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance
12 Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA’s and effectiveness checks to ensure issues are resolved

116

Quality Specialist Resume Examples & Samples

1 Perform final QA review and release for all shipments and associated documents, to ensure shipment meets customer specifications
2 Ensure center is “inspection ready” at all times by conducting daily, weekly, monthly, bi-annual and annual compliance checklist for the systematic monitoring of center quality compliance status. Document findings, develop and implement corrective actions
5 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management
6 Assist the AQM with the quality team in identifying and communicating non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meetings to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation at the center
7 Assist the AQM with review of Safety, Health and Environment Polices & Procedures. Ensure safety training and safety practices are implemented and followed within the center
8 Assist in conducting internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OSHA, FDA and other regulations, as applicable and develop center response for deficiencies
9 In the absence of the AQM, host external audits conducted by regulatory agencies and customers
11 Assist Plasma center staff in completing other special projects or assignments, as requested
12 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedures and documentation audits, as applicable. Promote safety in all actions
13 Follow all Standard Operating Procedures (SOPs), company policies and procedures
14 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA
Attention to detail and ability to follow written and verbal directions in exact detail required
Frequently required to make and accept modifications to working processes & procedures per SOP
Lead teams without the benefit of a direct reporting relationship
Exercise independent and good judgment to refer decisions when decisions fall out of the realm of established guidelines

117

Quality Specialist Resume Examples & Samples

3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action
4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements
5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used
7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues
8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management
9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation
10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center
11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers
12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective
13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable
14 Follow all Standard Operating Procedures (SOPs), company policies and procedures
15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA
16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable
17 Assist Plasma center staff in completing other special projects or assignments, as requested. 19 Perform other job-related duties, as assigned
80% of the time standing and walking and 20% of the time sitting 

118

Quality Specialist Resume Examples & Samples

Ensuring sustainability and continuous improvement of the Quality Management Systems by coordinating and conducting trainings, documentation, risk analysis, auditing and corrective-preventive activities
Reporting quality related information, analysis of data and metrics to initiate corrective-preventive actions and continuous improvement measures
Supporting continuous improvement activities in terms of process and system improvement, lessons learned and non conformance cost management
Planning and performing internal audits and assessments to ensure compliance to the requirements of the Quality Management System,
Introduction and application of quality methods and tools (QFD, FMEA, APQP, 8D, 6 Sigma, benchmarking) and ensure planning of quality related trainings
Coordination of product certification processes (TSE, CSA, UL, CCC, VDE…)
Sustainability of product safety by regular training, auditing and reporting
Planning and conducting product audits to ensure product safety and quality

119

Quality Specialist Resume Examples & Samples

QA-review of NCRs and Deviations
QA-review of Changes (ECRs, ECOs and LCOs)
QA-review of CAPAs
Supporting root cause analysis for complex problems/issues, if required
Managing the establishment of processes at Glostrup site
Supporting the overall KPI’s for QA Operations
Performing training for Agilent employees
Approval of validation and qualification documents related to finished products processes
Minimum 4 – 5 years of experience of handling NCR and Deviations
Strong knowledge of good documentation practice

120

Quality Specialist Resume Examples & Samples

Analyze product documentation, written and through database tools to determine compliance to customer specifications via multiple support tools
Generate product releases to Manufacturing which utilize Production Control schedules via multiple support tools
Track and detail product history through accurate recording keeping and charting techniques
Perform statistical process evaluations based upon departmental requests
The individual will need to pass a written exam and demonstrate the ability to interpret and present data
Should be fluent with Microsoft products (Word, Excel, PPT, Access) as well as having a high proficiency with computer use and manipulating databases
Be a “Team Player” but also a self-starter with the capability of working independently to find solutions to problems
Possess the mathematical skills required to work with conversion factors, formulas and other related functions. A written test will be administered
Possess verbal and written skills which allow for accurate explanations of all situations you are responsible to manage
Have the ability to use Microsoft Office Suite (Word, Excel, Access and Powerpoint). DocsOpen
Have a proven positive attendance record and at times required to support departmental needs through overtime and/or shift assignment

121

Quality Specialist Resume Examples & Samples

Build innovative automation systems to facilitate both functional and performance testing
Build tools to generate customer like data in test systems
BE in Computer Science or similar field
9+ years of relevant work experience, including development and/or test automation experience
Experience using Bug Tracking, Test case repository and Version Control Systems
Excellent coding skill in Java
Proven experience in building and enhancing automation tools
Must have hands on experience with at least one scripting language ex. Java Script
Experience with at least one UI Automation tool ex. Selenium
Good Database concepts and hands on experience with PL/SQL

122

Quality Specialist Resume Examples & Samples

Execute QC checks of Medicinal Products and other quality critical Clinical Trial Supplies during receipt, production and distribution
Support premise and equipment (P&E) maintenance and cleaning
GMP focus preferred
Experience in quality control activities preferred
Advanced level of English (writing and oral)
Experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Logistics Quality Management Oversight (LQMO) support preferred

123

Quality Specialist Resume Examples & Samples

Research, reporting, and data analysis focusing on NCQA and URAC accreditation activities (e.g. Demographic Analysis of Service Utilization Patterns, Trend Reports as assigned.)
Support and evaluation of clinical, service, and quality programs and activities (e.g., ADHD, Antidepressant Medication Management, Case Management, Aftercare, Post-Partum Depression)
Support plan-specific analysis and reporting related to HEDIS measures and participation on HEDIS committees and activities as assigned
Serve as key point of contact for all NH client quality initiatives
Assist in the annual member satisfaction surveys, including working with selected vendor, analyzing data, and writing reports
Regular review and update of Core Performance Indicator data for the oversight of clinical and quality performance and reporting results to the QIC
Assist with the Outpatient and Inpatient treatment record review processes; support Clinical teams on analysis, reporting and follow up of treatment record review performance data
Represent Quality Department at internal client-specific operations meetings
Responsible for assigned NCQA standards. This includes ensuring that Beacon remains in compliance with these standards
Other Duties as assigned
Strong business writing skills
Ability to conduct clinical literature reviews
Quantitative and Qualitative analysis capabilities

124

Quality Specialist Resume Examples & Samples

Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications
Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action
Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action
Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements
Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards
Initiate and, Schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure using the most current version of training materials at the center
Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues
Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development or corrective action plans, as necessary in partnership with management
Collaborate with the AQM with the quality team in identifying and communicating non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation
Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center
Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers
Responsible for Initiating, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective
Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. Promote safety in all actions
Follow all Standard Operating Procedures (SOPs), company policies and procedures
Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA
Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable
Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business
Assist Plasma center staff in completing other special projects or assignments, as requested
Perform other job-related duties, as assigned

125

Quality Specialist Resume Examples & Samples

Performs critical site reviews for per process environmental monitoring
Collaborates with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates
Performs GMP walk through inspections of assigned departments within the IPT to ensure compliance with cGMPs and regulatory requirements
Actively participates in the Tier process and uses this forum to escalate concerns and best practices
At least two years of relevant post-degree work experience in a laboratory, manufacturing, or quality position
Familiarity with GMP documentation review is a key skill necessary for success in this position

126

Quality Specialist Resume Examples & Samples

Must have knowledge on Excel, reporting and analysis (preferable)
Must have at least 3.0 rating for the last 4 quarters
Must not have incurred NDA for the past 6 months

127

Quality Specialist Resume Examples & Samples

Develops and maintains automation test framework for both frontend and backend
Cooperate the testing work across teams and locations
8+ years software testing experience including at least 3+ years automation experience
Bachelor’s degree in Computer Science, Engineering (any type) or a related field
Solid experience in designing and running functionality, security, scalability and performance tests on web applications and backend systems
Solid Experience with QA processes and tools, test management systems, QA automation, analyzing bug trends, Unix/Linux, SQL and related topics
Experience with Selenium is strong preferred
Knowledge of Java, HTTP, SSL, HTML, XML, CSS, or Javascript a plus
Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from leads/managers
Strong written and oral communications in English

128

Quality Specialist Resume Examples & Samples

Constructive Quality Assurance (Quality Risk Assessment, Test Strategy & Design, Test Process, Test Methodology)
Analytical Quality Assurance (Test Coordination & Execution, Test Management Systems, Test Design Techniques, Test Automation Techniques, Product Standard Tests)
Author test case descriptions and execute manual tests
Coordinate and support external testers, Coordinate with team members across locations
B.E/B.Tech/M.Tech/MS/MCA fulltime with 70% and above across
Experience working in a development team in the role as quality engineer
Analytical skills to drive root cause analysis for complex problems
Team player with excellent interpersonal skills
Very good English spoken and written skills
Ability to work effectively in a fast paced and changing business environment. Flexibility and adaptability are must haves to be successful in this role
Knowledge of ABAP development workbench and SAP Fiori
Experience in being part of a large-scale software development projects distributed across geographical locations
ISTQB certification

129

Quality Specialist Resume Examples & Samples

Support site Q&R lead to implement the Business’ long-range quality, regulatory and compliance policy
Create Q&R awareness level as determined within the organization
Enforces (a simplified) quality systems and harmonizes them across the Business
Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction
Manage compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations
Manages the review and approval of finished products developed for and by the company in accordance with their approved specifications
Ensures training- & competence management in line with PQMS requirements
Manage and monitor CAPA process

130

Quality Specialist Resume Examples & Samples

Must interface with and coordinate activity with all levels of management and staff
Must be proficient in the use of computers and software, including but not limited to Microsoft Word and Excel
Possess or be able to obtain PIV Operator Certification
Experience in maintenance or sterilization
CRC (Career Readiness Certification) Silver level

131

Quality Specialist Resume Examples & Samples

Identify and develop standards and related tools to establish the Quality System for mass spectrometry-based laboratory and obtain ISO certification
Follow and apply standards and guidelines to maintain Quality System across all development phases to maintain certification and prepare for sustainable deployment
Organize and supervise audits for the Nutrition Analytics Laboratory
Define and update the laboratory procedures, instructions and tools in the defined area
Promote quality standards and requirements towards internal and external collaborators of the laboratory
MSc or PhD degree in analytical chemistry with a strong working knowledge of mass spectrometry and liquid chromatography techniques
At least 3-4 years’ experience in Quality Management in an analytical laboratory
Proven hands-on experience in implementing and using ISO 17025 and/or 15189 norms
Fluency in English and French

132

Quality Specialist Resume Examples & Samples

Ensure the quality of products produced at Playtex Business Unit is consistent with EPC / Playtex Mfg. Inc. Quality standards
Support Sun Care quality related projects: internal and external
Creates reports for management, and other internal groups. Reports include validation related protocols and reports, trip, audit, and status
Ability to work with the validation cross functional team relative to generating, executing and closing validation protocols and reports
Support the Sun Care and Shave Prep Consumer Complaints Program by evaluating and testing complaint related samples when required
Support the Annual Product Review (APR) program when required
Plan, schedule and conduct process and product quality audits to appropriate regulations and Playtex requirements
Support closure of open Corrective Action Preventative Action (CAPA) incidents
Ability to work with vendors, contract manufacturers and cross functional teams relative to problem resolution
Support closing of non-conformances and deviations, if needed
Support the Quality Engineering team to ensure adherence to procedures and regulatory compliance
Support the Quality Engineering team on line trials, equipment qualifications, formula validations and process/packaging validation exercises
Submit reports to Quality Engineers and QA Management
Ability to write, review, revise and approve Quality SOP’s and forms
Ability to review and approve New Product Specifications, Bill Of Materials, Packaging Assembly Specs, Non Conformance Reports and Deviations when required
Ability to close communication loops effectively with internal and external customers
Ability to facilitate a cross functional team in relationship to quality issues
Associate Degree in related field
Qualification/Validation experience desired
Five years minimum experience working in a manufacturing environment in a quality related field
Five years minimum experience in an FDA regulated business or ISO:9000 Quality System
ASQ certification preferred
QC laboratory knowledge preferred
Knowledge of CFR 210/211 and/or CFR 820
Strong problem solving skills, including root cause analysis tools
Strong statistics and sampling plans background
Ability and willingness to travel, as in the execution of the duties of this position the employee may travel up to approximately 10%, or slightly more, of their work time

133

Quality Specialist Resume Examples & Samples

Creates and maintains quality records (as built, supplier, and production records)
Assists in review of proposals, contracts, regulatory, program and customer requirements to prepare quality assurance plans and tests for hardware and software products, processes and services
Maintains Quality directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed using established procedures
Collects and verifies data to support the identification of root cause routine problems
Provides ideas and concepts for corrective action development
Supports quality source selection and process reviews of suppliers' ability to meet program quality requirements
Compiles data and provides recommendations for material review disposition
More than 1 year of experience in Quality Management Systems (QMS)
Experience in Supplier Quality processes
More than 1 year of years of experience in the inspection of parts, components, assemblies or units
More than 1 year of experience with Root Cause Corrective Action (RCCA) tools
More than 1 year of Quality Inspection experience, including FAI (First Article Inspection)

134

Quality Specialist Resume Examples & Samples

Less than 1 year of Quality experience
Less than 1 year of experience in MRB (Materials Review Board) and/or corrective action experience
Less than 1 year of Quality Inspection experience, including FAI (First Article Inspection)
Less than 1 year of experience in Quality Management Systems (QMS)

135

Quality Specialist Resume Examples & Samples

Review Quality parameters and make changes whenever necessary in consultation with Operations
Defining the quality parameters to the call agents and QA’s and defining the scope of improvisation
Willing to work in a diverse environment

136

Quality Specialist Resume Examples & Samples

Lead the weekly cross functional quality reviews, preparation and presentation of the information for management review and decision making
Tracking of the status and follow up of product improvements to support the efficient implementation and timeliness of dedicated quality programs and initiatives
Management of the Corrective and Preventive Action (CAPA) process as the single point of contact for LPSD owned activities. This includes management of the records in the CAPA system and follow up with the dedicated teams
Coordination and execution of engineering change requests (ECR)and engineering change orders (ECO) as the representative of the design team
Provide guidance, expertise and consulting services to support the NPI teams to effectively follow the product lifecycle
Review of all relevant product livecycle deliverables to assure compliance with internal and external requirements
Follow-up on phase exit topics to assure timely execution
Coordination of risk management and lead of according activities
Preparation of document packages for regulatory reviews for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. This includes also the representation of LPSD in audits
Oversee the efficient implementation of dedicated quality programs and processes in order to promote and establish a customer-centric culture
University Degree (Bachelor, Master, or Diploma) in engineering or science or equivalent (complemented by a post-graduate and/or certification/license)
Typically 6-8 years professional experience in Regulatory/Quality, R&D, Manufacturing or Support of scientific, test or measurement instruments
Solid understanding of quality philosophy and quality management systems
Excellent written and verbal communication skills in German and English
Ability to work well in a collaborative, interdisciplinary and cross functional team
Self-organized and independent work style with strong customer focus
Ability to manage several issues in parallel while keeping focus on priority and due dates
Strong influencing skills paired with project management/leadership skills
Optimistic, eager, forward-looking and open attitude that supplements our team

137

Quality Specialist Resume Examples & Samples

2 or more years of work experience in a quality function
Experience performing independently
At least 3 years of experience with Quality Metrics / Analytical Statistical Analysis
Minimum 3 years experience with AS9100 application
Demonstrated ability to lead process improvements using structured problem solving methods
This position requires an active (or the ability to obtain) U.S. Security Clearance, for which the U.S. Government requires U.S. Citizenship
Quality audit experience
3 years experience leading systematic problem solving
Experience with Boeing lab products desirable
Experience working with DoD customers (i.e. DCMA and DCAA)
A DoD Secret clearance post start

138

Quality Specialist Resume Examples & Samples

Perform Batch record reviews
Reviews methods and specifications to ensure alignment with Good Manufacturing Practices (GMPs) and other applicable worldwide regulations
Review and approve production and analytical documentation accompanying the release of Packaged Pharmaceuticals to ensure conformance to appropriate regulatory requirements
Scientist communicates and resolves comments with client areas
B.S. in Chemistry/Biology or related field
Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations
Effective communications (oral/written) and interpersonal skills are necessary

139

Quality Specialist Resume Examples & Samples

High school diploma or GED equivalent required
5+ years experience in quality laboratory inspection environment
Basic computer skills with knowledge of MS Office
Strong knowledge of Geometric Dimensioning & Tolerancing
Experience with inspection equipment including CMM and Form Tester
Good interpersonal skills; works independently/productively with little supervision
Maintains a high energy level
Consistently shows good attention to detail and follow-up skills to complete assignments
Team oriented and willingness to perform a wide range of departmental tasks

140

Quality Specialist Resume Examples & Samples

Drive the Philips Healthcare Quality System deployment to meet ISO13485 Quality Management System requirements, Philips Quality Policies/Procedures, and Korea medical device regulations (KGIP/KGSP)
Set up essential quality processes, and support process deployment (and development when necessary) of local procedures and training programs to meet the needs for field employees to include areas such as quality & regulatory requirements, customer complaints and safety incident reports
Take key initiatives to Quality compliance strategy to Philips standards & policies and Korea regulations
Execute local / cross-country quality audits
Ensure CAPA monitoring and facilitating
Experience in Quality & Regulatory in a technical oriented environment preferably with experience of dealing with Notified Bodies, Korea MFDS and gov’t agencies responsible for medical device regulations
Preferred ISO lead/internal auditors. Working knowledge of relevant international/local/device Regulations (ISO13485, IEC60601-1, software lifecycle management, KGIP/KGMP/KGSP regulations)
Demonstrated ability to: take initiative, communicate with others, get results by convincing and perform thorough investigations
Computer skills including database management, word processing and spreadsheets are also necessary
Rigorous and precise work is compulsory
Fluent in English and Korean, verbal and written communications

141

Quality Specialist Resume Examples & Samples

Associate degree or equivalent in Biology, Chemistry, or related field
2+ years, experience in a regulated manufacturing industry or equivalent combination of education and experience
Understanding of standards as they apply to products manufactured by Bio-Rad
Basic understanding of GMP and quality systems
Working knowledge of device/drug/biotech manufacturing processes
SAP application, Microsoft Office, Detail-oriented and ability to multitask. Problem solving, decision making, time management, organization, communication, leadership, and computer skills

142

Quality Specialist Resume Examples & Samples

Strong communication skills with both internal customers, including verbal and written
Must demonstrate the ability to produce high quality results
Basic Microsoft Office sills are required including solid Excel experience preferred
Previous Mortgage Experience preferred but not required

143

Quality Specialist Resume Examples & Samples

Becomes fully trained in Merck Quality SOPs, production SOPs as needed, and SAP functions as required by Quality Specialists
Responsible for the review and release of filled container batches destined for both domestic and international markets
Prepares and submits release protocols to CBER. Prepares CoAs to support regulatory filings
Works cross-functionally to resolve outstanding issues from the manufacture or testing of the batch (e.g., batch record review, investigations, testing, CRs, etc.) to ensure the timely submission/release of the material
Ensures compliance with departmental procedures
Ensure proper identification of release status and control of materials through maintenance of batch and stock status in SAP and through physical tagging of material as required
At least one year of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations
Evidence of leadership skills coupled with good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
Effectiveness and creativity in approaching and solving technical problems
Attention to detail, flexibility and an awareness of production and quality control problems
Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, Outlook, and/or MS Access)
Familiarity with batch dispositioning (release) activities is a strongly preferred skill necessary for success in this position; prior batch disposition experience is a plus

144

Quality Specialist Resume Examples & Samples

Perform Quality Audits
Participate of cross-site Calibration sessions, engaging with regional stakeholders and peers
Report on QA results: Produce daily, weekly and monthly analyses and reports on process adherence trends and deviation root causes at investigator, team and site levels
Perform data-mining and analysis to support programs as well as identifying opportunities for quality improvements
Provide coaching tips and training suggestions to managers for targeted areas for improvement Build quality tips and content based on QA data mining observations
Actively participate of the Knowledge/Content lifecycle: detect and communicate SOP improvements, provide TCKR Champion or QA Content Approver support
Identify training gaps and communicate them to management and training
Projects & Kaizen: Provide inputs to GPO, BPR for SOP/Process/Tool improvements or changes
Contribute with the development of reporting systems and quality tools automation to reduce QA manual efforts and improve QA yields
Floor support and all-hands-on-deck when required
A minimum of 6 month recent TRMS production experience and proven track record of exceeding quality goals
Deep understanding of TRMS processes, Tools and SOPs
Knowledge in SQL to fetch data requirements and experience working with databases
Intermediate proficiency in MS Excel and SharePoint
Knowledge of Project Management fundamentals
Proven experience in Kaizen / Process Improvements events
Strong communication skills, both written and orally, including the ability to communicate and positively influence multiple audiences and various cultural backgrounds
Excellent organizational and time management skills. Schedule flexibility
Good analytical, logic and reasoning skills. Ability to draw conclusions and recommend improvement initiatives
This position is unable to sponsor work visas
Prior experience of quality auditing, data analysis, coaching and development
Advanced knowledge of MS Excel and SharePoint
Strong knowledge of QA methodologies and tools
Lean-Six Sigma knowledge or experience

145

Quality Specialist Resume Examples & Samples

Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally
Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint
Determine regulatory reportability of complaints received
Communicate with customers, call center reps and FSEs to gather more data on complaints as needed
Confirm complaint condition and determine corrective action (including CAPA as needed)
Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed
Assess if the Risk assessment is covering the hazard in the complaint
Complete all needed records in a timely and accurate manner

146

Quality Specialist Resume Examples & Samples

Manages CAPA, NCMR, and Deviation systems. Prepares CAPA, NCMR, and Deviation metrics for Management Review
Assists in external and internal auditing of suppliers and QMS
Supports activities regarding supplier qualification and performance. Assists in review of supplier files for compliance to appropriate GMP standards
Reviews and approves validation protocol and reports
Performs some trainings for GMP, GDP, ISO 13485, etc
Cooperates and respectfully communicates with external and internal customers
Bachelor’s degree and 2+ years experience in medical device quality departments
Experience in writing QMS documentation
Primary activities will take place in an office setting at a desk and on a computer in a temperature controlled environment
Occasional safe lifting of up to 30 pounds
Ability to consistently meet critical deadlines
Ability to follow Standardized Operating Procedures (SOPs), as well as written and verbal instructions
Excellent written and verbal communication skills with the ability to train employees
Ability to manage multiple projects and changing priorities

147

Quality Specialist Resume Examples & Samples

Willing to obtain Level II certification in magnetic particle testing and penetrant testing with a minimum of 2 years applicable experience utilizing this level of certification
Experience in UT level II ultrasonic shear wave per ASNT-TC-1A. Should be willing to obtain documentation of certification
Possess ability to learn QualTrax (Quality Management System), Laserfiche (Document retention system) and Quick software
Possess working knowledge of inspection tools and standard equipment applicable to the site operations
Previous experience in a manufacturing assembly environment, with additional preference to a valve manufacturing history
Ability to read and interpret documents such as department work instructions, blue prints, process code documents, computer software manuals, safety rules, employee handbook and procedure manuals
Display ability to write routine reports and correspondence
Requires establishing relationships and developed communication skills with internal and/or external contacts and organizations
Ability to meet deadlines and complete tasks with minimal supervision or direction
Ability to support production needs and identify improvements in production operations and effectively communicate both opportunities and solutions
Ability to work with others to accomplish common goals and make the business successful
Displays flexibility in approach to work scope and daily activities to ensure the site and company meets its production and financial goals
Ability to calculate figures and amounts such as proportions, percentages, area, circumference and volume
Ability to deal with problems through creative solutions
Minimum of 4 year of related production or mechanical assembly experience and/or training
Have minimum 2 year experience with defect analysis with the following four types of valves: ball valves, pressure relief, level controllers, weld bodies
Knowledge of First Article, NDE, In-Process and Final inspections

148

Quality Specialist Resume Examples & Samples

Ability to work with others to accomplish common goals
Minimum of 2 year of related production or mechanical assembly experience and/or training
Have minimum 1 year experience with defect analysis with at least two of the following types of valves: ball valves, pressure relief, level controllers, weld bodies

149

Quality Specialist Resume Examples & Samples

Management of the site HACCP program and sanitation program in production
Ensure production is in accordance with the sites quality management system (ISO) and in accordance with the site’s systems to manage product quality in a way, which ascertains continuous improvement of quality KPI's (e.g. GMP, consumer/Trade and BU complaints)
Ensure Food Safety of all manufactured products by ensuring understanding and compliance with relevant legal and corporate requirements (e.g. HACCP, QCMS) and by continuous verification of the compliance and effectiveness of installed systems
Continuously drive improvements in the area whilst balancing against other site KPI’s
Assure Quality by ensuring all specification parameters are met and corrective action plans are in place to address non conformances
Establish and maintain on line / at line testing through the provision of appropriate methodology, training support and test verification/validation
Ensure all audit criteria regarding production are met
Support internal and external change projects as assigned
Support any trials driven by NPD/Change
Assist in ensuring all plant operating procedures and work instructions are in place in accordance with quality system requirements before manufacturing/accepting products for commercial production
Manage the investigation, reporting and corrective actions (if any) against customer and consumer complaints received in the Vegemite department
Support crisis situations and major quality issues with technically accurate and timely root cause investigation and corrective actions on specific issues

150

Quality Specialist Resume Examples & Samples

BPO experience operations preferred
Applicants must be willing to work in Quezon City
Background in handling a technical account

151

Quality Specialist Resume Examples & Samples

Material certification requires gathering information from a variety of sources, including
SAP (business information system)
Chemistry reports
Inspection reports
Mechanical reports
Sales orders
Production routers
Specifications
Data from tests are evaluated against required specifications and prepared for certification of Materion Elmore products including beryllium metal, beryllium oxide, and copper alloys
Responsible for maintaining Quality Assurance databases and the implementation of new databases when necessary. Creates, maintains and oversees document control and department reports to assure proper security
After adequate training the Quality Specialist is responsible for providing assistance and training to all business units in regards to QSI databases
Serves as the administrator for the IQS calibration system
Conducts and participates in internal, third party and customer audits as needed
Instrumental in maintaining compliance to AS9100 quality system and other certifications
Purchases departmental supplies and schedules necessary service to keep office equipment in operation
Provides support for all areas of the quality department, including inspection, laboratories and quality engineering
Performs other related duties as assigned
Must have 2 years of manufacturing and/or quality control experience and strong math skills
The successful candidate must have excellent interpersonal skills and basic understanding of chemistry, statistics and math
The position requires the ability to organize work, recognize problems and prioritize work
We are seeking a candidate with above average computer skills including Microsoft Office
Experience in SAP is a plus

152

Quality Specialist Resume Examples & Samples

Interact with internal and external clients via phone and email to ensure that files are cleared and insured timely and accurately
Review and communicate any recurring trends that may cause delay in the closing of loans
Verify the presence of loan documents and effectively assess if a loan file is adequately documented
Validate loan data to ensure consistency of documents and adherence to guidelines
Proactively resolve loan level issues identified through exception reporting
Ensure loans are processed in accordance with GSE and PennyMac policies
Interface and coordinate with other departments to expeditiously resolve issues
Complete special assignments necessary to support the overall business strategy
Perform other related duties as required and assigned
Demonstrate behaviors which are aligned with the organization’s desired culture and values
4 Year college degree (Bachelor) or equivalent work experience
1+ years

153

Quality Specialist Resume Examples & Samples

Responsible for implementing and monitoring systems in support of FDA Regulations and ISO Standards; applying designs, developing/implementing methods and procedures for inspecting and testing, and evaluating the quality and performance requirements of products and processes
The Quality Specialist will work on complex problems in which analysis of situations and data requires evaluation of various factors relating to supplier Quality System measurements and overall product performance concerns. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining and measuring results
Validation and qualification methods - Identify and describe how validation and qualification methods are used for process, product, and service designs. (Application)
Interpretation of technical drawings and specifications - Interpret basic technical drawings and specification requirements in relation to product and process characteristics. (Application)
Determining product and process control methods - Identify and apply methods such as job instructions, process control points, etc. (Application)
Prevention - Identify and apply methods to maintain and improve process and product reliability. (Application)
Maintenance scheduling - Identify, classify, and describe methods of predictive and preventive maintenance. (Application)
Reliability Failure Analysis and Reporting - Analyze reliability failure information and evaluate possible actions to improve or correct performance. (Evaluation)
Process capability evaluation - Identify and interpret elements of capability from various sources of data. (Comprehension)
Purchasing concepts - Identify sources of purchasing information, requirements, etc. and support common elements of purchasing controls. (Application)
Inspection, measuring, and test equipment - Identify and apply knowledge of control, performance, reliability and calibration requirements relating to standard equipment/tools utilized in the recording of processes, temperature, and product measurements. (Comprehension)
Reliability/Safety/Hazard Assessment Tools
Failure Mode and Effects Analysis (FMEA). Define, construct, and interpret FMEAs. (Application)
Failure Mode and Effects Criticality Analysis (FMECA). Define, construct, and interpret FMECAs. (Application)
Cause and Effect analysis (Fishbone). Define, construct, and interpret FTAs. (Application)
Proficient in MS computer applications: Outlook, Word, Excel, and Visio. Knowledge and application of environmental monitoring equipment is required
Effective oral and written communication skills are mandatory
Knowledge of Statistical Process Control, Probability and graphical analysis
The candidate must be able to gather the appropriate data to make informed decisions, as well as form teams when collective discussions are applicable

154

Quality Specialist Resume Examples & Samples

Ability to prepare quality control reports including data analysis
Ability to conduct internal audits to ensure processes meet required quality and customer standards
Ability to identify and institute corrective action when necessary
Responsible for inspection processes including first article inspections
Strong analytical, problem solving, and decision making skills

155

Quality Specialist Resume Examples & Samples

Responsible for the reporting of all quality KPI’s for the Minot, ND Facility
Fully support the QMS by reviewing documents, assuring alignment to industry and Baker Hughes standards
Responsible for the scheduling and control of all calibrated equipment within the facility
Demonstrate project management best practices and use of quality management tools and handle special projects as required
Conducting all business activities in accordance with Baker Hughes Health, Safety and Environmental policies, Legal Compliance requirements and company core values
Knowledge of testing and manufacturing techniques and processes
Proficient in the interpretation of Engineering drawing and customer requirements and specifications
May provide direction and training to less senior inspectors
Implements corrective action and preventive measures to ensure quality practices are in place in the Re-manufacturing processes
Associate’s Degree with 3+ years of Quality or Reliability experience
In depth knowledge of industry quality standards ISO or API
Understanding of business processes and industry standards
Skills in quality control and calibration
Must be able to effectively communicate in English
Competency in SAP
Competency in Mini Tab 17
Knowledge of BHI quality metrics and QMS
Understanding of business processes, industry standards, and BHI technologies

156

Quality Specialist Resume Examples & Samples

13 Maintain clean efficient work environment, and ensure sufficient operating supplies and forms are available. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedures and documentation audits, as applicable. Promote safety in all actions
16 Maintain an environment free from harassment or intimidation of any employee by co-workers, management personnel or any external source. Immediately report (orally and/or in writing) all incidents of harassment to a manger and HR
17 Maintain professional image and confidentiality of all company records and information at all times
18 May, be cross-trained in all technical areas and other functions to meet business needs
19 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business
20 Perform other job-related duties as assigned

157

Quality Specialist Resume Examples & Samples

Manage and coordinate the activities of the change control and customer communication process
Assist areas for preparation of the change requests, documenting the details of change, insuring the appropriate functional reviews and sign-off
Assist to enter the changes in Trackwise or manual records, and notify affected departments/areas
Maintain the change control system, conduct meeting to discuss pending change controls, track the status and provide report to management
Identify area of concern / roadblock in completing the change control evaluation, and resolve or elevate the concern to the management, so the change can be completed in a timely fashion
Collaborate with areas/departments on technical requirement and recommend procedures and documentation for control
Prepare and/or review the notification letter
Ensure the notification letter is communicated in a timely manner
Maintain the change control history, records and documentation to demonstrate compliance to regulations and company policies, procedures and requirements
Assist areas for training on change control procedures and key compliance requirements as applied to West products and processes
Subject Matter Expert for change control process
Provide training on proper completion of change control documentation
Audit completed change controls to assure compliance
Support Quality Systems specialists with specifications, investigations, procedures, and validation as needed

158

Quality Specialist Resume Examples & Samples

Draft, negotiate, and review customer/laboratory/supplier quality agreements on behalf of West Pharmaceutical Services in accordance with organizational procedures
Liaise directly with external stakeholders and all levels of West personnel across West locations, local and global, for the coordination of agreements and to ensure appropriate reviews and approvals
Execute activities relating to tracking and managing agreements, including administrative tasks
Collaborate with global, cross-functional teams to support supplier quality harmonization projects
Assist in developing, implementing, and maintaining written procedures
Support processes for other agreements, as required (e.g., confidentiality agreements)
Assist with specification alignment/management
Perform/assist with supplier quality assessments, including on-site quality audits, to confirm supplier compliance to applicable regulatory standards and West requirements
Perform/assist with Local and Corporate Internal Quality Audits
Builds knowledge of the organization, processes, and customers
Solves a range of straightforward problems
Analyzes possible solutions using standard procedure
Receives a moderate level of guidance and direction
Education: Bachelor’s Degree or equivalent work experience
Understands interpretation and application of quality standards in a regulated environment, such as ISO 9001, ISO 13485, regulatory agency requirements
Proven ability to work in a virtual environment in a global organization
Working with and contributing to a team as well as working well independently
Excellent interpersonal skills. Eagerness to interact with people and to build networks
Excellent verbal and written communication/presentation skills
Bachelor’s Degree in Business, Supply Chain, Quality, Regulatory, or Sciences is preferred
Proficiency with MS Office products, including Outlook, Word, Excel, and related electronic tools
Experience conducting quality audits

159

Quality Specialist Resume Examples & Samples

Analyze issues and/or inefficient processes discovered during monitoring, calibrations, listening sessions, or research and work with management team to correct
Develop, research, analyze and communicate Interaction Analytics processes and results
Support escalations investigations and case studies (EMT, OOP, ECR, Dealer Support, and Social Media)
Generate regularly scheduled quality reports for Operation Management team as well as management at each vendor location
Ad hoc assignments as business requires
2-4 years experience in an inbound telephone contact center
2+ years experience in call center quality assurance management

160

Quality Specialist Resume Examples & Samples

Visual inspection of GE and customer owned items arriving to the facility. Ensure the appropriate documentation for incoming parts is received and verified compliant against applicable specifications
Complete accurate visual inspection of Subsea & Drilling equipment at various stages of the workshop maintenance process (visual, dimensional, hardness, etc)
Witness and verification of acceptance testing
Create and maintain records/reports for completed inspection activities (inwards, survey, dimensional, mechanical testing, etc)
Identifies, reports and quarantines non-conforming product
Support and promote regulatory compliance of QMS
Ensure safe practices are used in compliance with all GE policies
Ensures that all aspects of Quality are maintained in line with the company Quality Policy
Work cross-functionally other departments to drive excellence in product quality
Complete additional quality responsibilities as allocated
Metal &/or Engineering Trade Certificate
5 years industry &/or Inspection experience
Detailed knowledge of inspection and metrology techniques and processes
Thorough understanding of manufacturing drawings and specifications
Knowledge of current industry standards
Detailed knowledge of requirements associated with the control of monitoring and measuring devices
Experienced and familiar with the requirements of formal Quality Management Systems and standards, such as ISO 9001:2015 and API Q1/Q2/6A
Ability to handle multiple issues / priorities while working towards agreed schedules and deadlines
Knowledge of Subsea equipment
Working knowledge of NDT, Coating, Machining processes
Mechanical / Engineering Degree desirable
Additional Formal Quality Qualifications desirable (e.g. NDT, Welding, Coating, etc)

161

Quality Specialist Resume Examples & Samples

Involved in all quality-related matters
Involved in resolution of VS deviations Supports Quality initiatives
Writes, revises, approves and processes quality related documents
Participation in the Validation activities
Participation in the Risk assessments
Participation in the Change control process
Helps to assure the quality of VS processes through Quality ”Gemba” walks and management of the VS process per governing process SOPs
Works within TrackWise to manage Impact assessment, RCA and CAPA records together with SME
May support VS projects (PPI, Kaizen, Just-do-it, NPI and Technology transfers)
Participation in the reviews or development of training
May review batch records for regulated products
Demonstrates enthusiasm, takes accountability and drives for results

162

Quality Specialist Resume Examples & Samples

Review and approve specifications and build documentation for completeness, accuracy, regulatory compliance, and quality objectives
Develop, maintain, and take actions to improve quality metrics such as First Pass Yield, nonconformance trends, and quality escapes
Work closely with technicians, inspectors, manufacturing engineers, and production management to identify and lead continuous improvement initiatives
Use statistical tools such as Measurement Systems Analysis (MSA), Design of Experiments (DOE), and Statistical Process Control (SPC) to support steering production processes
Assess existing processes and support continual improvement initiatives
Collaborate across disciplines to ensure efficiency and consistency across the organization
Support the Material Review Board (MRB) process by managing non-conformances, evaluating their root cause, and implementing corrective and preventive action, using tools such as 5 Why, 8D, Fishbone, and others
Support the Corrective Action process and guide Corrective Action teams in development of corrective action plans, implement permanent solutions, and participate in evaluation of effectiveness
Conduct detailed in-process and final inspections to launch vehicle components, using detailed drawings, CAD models, and established processes to verify conformance to design requirements
Support Quality Management System policies and procedure documentation, assess compliance to company and industry standards, initiate and lead continual improvement and lean manufacturing initiatives
Additional projects and tasks assigned as required
Bachelor’s in an Engineering or technical field or at least 4 years of experience in quality inspection or manufacturing role
Must be able to read and interpret design drawings and CAD models
Dedicated to adopting a Lean approach to quality without compromising safety or reliability
Ability to identify and maintain priorities for tasks and projects
Ability to work in a fast-paced, cross-functional environment, both independently and with a team
Strong communication and technical skills
Proactive, self-motivated, driven, and committed to a team approach
Working knowledge of Microsoft Office Suite
Experience with AS 9100, ISO 9001, ISO/TS 16949, ISO 13485, or similar Quality Management System
Practical experience with GD&T and skillful use of metrology tools and gages
Knowledge of quality tools such as Lean principles, Six Sigma, Root Cause Analysis and Corrective Action, Advanced Product Quality Planning (APQP), Metrology, Process Failure Mode and Effects Analysis (PFMEA), Control Plans, and various problem solving approaches
Knowledge of Statistical Analysis Tools such as Design of Experiments (DOE), Statistical Process Control (SPC), Analysis of Variance (ANOVA), and Minitab (or similar)

163

Quality Specialist Resume Examples & Samples

Quality Specialist is responsible for the inspection of our optical components, maintaining the proper documentation, and performing transactions in our ERP system
Using metrology equipment including but not limited to calipers, microscopes, interferometers, profilometers and optical comparators, and laser based set-ups in order to inspect optical components and ensure compliance to the drawing
Perform incoming, in process, first article and final inspection
Complete, review, and maintain acceptance documentation
Perform applicable transactions in our ERP system
Maintain a neat and orderly work area
Maintain and order supplies for the department
Participate in team projects developing process improvement methods, solutions, and procedures to enhance quality, cost, and scheduling
Follow Environmental Health and Safety Procedures
Other duties as directed

164

Quality Specialist Resume Examples & Samples

Analytical Quality Assurance (Test Coordination & Execution, Test Management Systems, Test Design Techniques, Test Automation, Product Standard Tests)
Follow up on test results, contribute to working software at the end of each sprint
Bachelor’s degree in computer science, engineering or related field
Experience working in a development team in the role as quality engineer or professional tester
Experience working in an international, multi-cultural setups
Programming experience in JAVA or ABAP

165

Quality Specialist Resume Examples & Samples

Prepare, plan and support delivery of programs using both quality and program management methodologies
Review, discuss and communicate quality aspects of the product area to internal, external, and senior stakeholders (e.g. S/4 Hana)
Plan and execute test cycles including configuration of test systems and continuously improve test effectiveness and test efficiency
Prove strong analytical and reporting skills in order to dig into incidents and drive possible solutions
Define, roll-Out and present development and quality processes
Identify and initiate continuous improvement processes
Take ownership to drive projects independently
University degree in Computer Science or a related subject
Excellent experience in Quality Management and/or Program Management
Excellent Project Management skills and experience
Strong knowledge and experience in NetWeaver and/or SAP Cloud Platform technologies
Proven cross-functional communication skills
Analytical thinking and pragmatic problem solving in a cross-cultural setup
Agility, openness and ability to work autonomously and take responsibility
Show leadership with professional presentation skills
Broad network within SAP organizations
Good team player with rich interpersonal skills
Conflict, mediation and negotiation skills
Expertise and strong knowledge of SAP process, program management as well as quality assurance and test related tools, e.g. PSC, SIRIUS, JIRA, etc
Expertise in setup and analysis of Dashboards and Reporting
Rich knowledge and experience in Agile/SCRUM development methodologies and continuous development models
At least 4 years in managing projects in context of Development and/or Quality Management
At least 2 years experience with classical Program Management and/or Quality Management @ SAP
Strong working experience in cross-functional projects

166

Quality Specialist Resume Examples & Samples

B.E / B.Tech / M.Tech / MS / MCA fulltime with 65% and above across
Strong background of SAP Quality processes, Testing, Automation (at-least one automation tool)
Experience in manual test execution with standard test design techniques
Sound Hands on experience in designing and developing Test Automation using any of the tools like eCATTs, START, Selenium, QTP
Constructive Quality Assurance (Quality Risk Assessment, Test Strategy & Design, Test Process, Test Methodology, Test Tool Evaluation & Development)
3 - 5 years of relevant experience in Testing and Quality Engineering

167

Quality Specialist Resume Examples & Samples

Your ability to work well autonomously and work collaboratively within the auditor team and the broader quality organization
Your strong critical thinking, written and verbal communication skills
Your ability to work independently and the flexibiliy to work within a team
Excellent MS Office skills (e.g. Excel, PowerPoint, Word)
Your ability to interact with multiple levels of the organization
Ability to multi-task and prioritize support tasks with a keen sense of urgency
Your flexibility and ability to work overtime based on established SLA’s with the business for review completion

168

Quality Specialist Resume Examples & Samples

Oversee day to day operations and give functional guidance to Quality Technicians
Leads the implementation and verification of procedures to control non-conforming materials and products. Leads the NCM Process and disposition of non-conforming product
Provide technical support to manufacturing and R&D as required to assess Quality of finished product. This could involve product testing
Investigate all product quality non-conformances. Assist in Consumer Safety investigations as required
Work closely with all departments (Production, Sanitation, Maintenance, R&D, Procurement) to identify and rectify any quality defects in products
Co-ordinate with warehouse to ensure product is dispositioned as per QA instructions in a timely manner
Assist production in investigating Defective Materials and follow up with suppliers
Provides feedback to the site through regular communication in daily operations meetings
Reports and communicates results, issues and improvements to relevant stakeholders. Manages and reports incidents in line with Unilever incident management procedures
Perform mock recalls or traceability exercises
Support quality and food safety programs including FDA, FSCC-22000 and other third party audits
Assist QA Manager in assessing training and development needs related to quality program
Supports innovation funnel activities within the supply chain as appropriate for site quality
Participates in WCM Quality Pillar initiatives. Participates on other Pillars as a representative of the Quality Pillar
Supports data collection, analysis and assignment to standard Quality loss trees in support of operational KPIs reporting
Leads structured quality improvement activities related to customer, consumer issues and CRQS gaps
Utilizes advanced statistical knowledge to support process capability studies to maintain alignment between capabilities of site processing and filling operations and specification limits
Utilizes SAP QM and Unilever specifications including Interspec system and supports verification of use for quality purposes
Supports the implementation and maintenance of system where key quality data and information are recorded and preserved

169

Quality Specialist Resume Examples & Samples

Coordinates assigned quality and process improvement activities which may include accreditation support, process improvement projects, quality studies, CQI (continuous quality improvement) process training for staff, prevention program coordination, care coordination initiatives, satisfaction survey coordination and follow-up, provider and member advisory groups, tracking of adverse incidents. monitoring of performance guarantees, provider profiling support, and CAPs and customer related quality initiatives
Conducts quality control reviews and internal audits. Summarizes findings and prepare reports on findings. Assists in the preparation of customer audits
Conducts analyses of data findings for quality and process improvement and assists in report preparation for internal and external customers
Supports assigned quality committees and work groups through comprehensive project management ensuring that documentation is accurate and timely, agenda items presented and follow-up actions taken

170

Quality Specialist Resume Examples & Samples

Early involvement in new product startups and relocation projects in terms of quality assurance and ensure consideration of all quality requirements including Siemens Norms, national and international standards requirements
Detailed test and inspection planning including all necessary laboratory electrical tests for finished products which will ensure all quality requirements with minimum inspection at all steps of manufacturing
Establishing and maintaining effectiveness of self inspections conducted by operators themselves by training employees and monitoring efficiency
Ensuring sustainability of the quality assurance process by coordinating and conducting trainings, documentation, risk analysis, auditing and corrective-preventive activities
Solving quality issues and conducting process improvement actions when necessary in a strong cooperation with headquarter and other involved foreign location’s quality departments
Utilization of quality methods and tools (SPC, FMEA, APQP, 8D, 6 Sigma, etc) to improve process capability
Support and participation in product certification process (TS, CSA, UL, CCC, VDE)
Handling of customer complaints by analyzing failures, taking necessary corrective actions and reporting

171

Quality Specialist Resume Examples & Samples

A Master Degree in Engineering, Pharmacy, Biology, Biochemistry, or similar
Fluent in English. Basic understanding of Danish will be helpful since production procedures are written in Danish. A wiliness to learn the language would be an add-on
Has a positive, open-minded and proactive mind-set
Can work well independently as well as in teams
Has excellent and effective communication skills
Can work in collaboration with different departments
Can prioritize work to meet the required timelines
Has an analytical and quality mind-set

172

Quality Specialist Resume Examples & Samples

Responsible for the safety, quality, delivery and productivity performance of the QA Lab during all shifts
Assigns relevant duties to Quality Technicians for all shifts
Coordinate daily time, staffing requirements and reports KRONOS on weekly basis
Manage and report all aspects of PPAP receipt, validation, and completion
Interface with suppliers to communicate and resolve open issues
Interface with GKN line companies to communicate and resolve open issues
Make decisions regarding disposition of questionable components and assemblies
Responsible for escalating problems or issues that may prevent them achieving any safety, quality, delivery or productivity target to the relevant owners
Follow and apply TS-16949 procedures

173

Quality Specialist Resume Examples & Samples

Supporting sustainability and continuous improvement of the Quality Management System by coordinating and conducting trainings, documentation, risk analysis, auditing and corrective-preventive activities
Planning and performing internal audits and assessments to ensure compliance to the requirements of the Quality Management System
Introduction and application of quality methods and tools and ensure planning of quality related trainings
Coordination of TR&S (Technical Regulation & Standardization) Management
Coordination of QDMS (Quality Document Management System), ensuring its implementation and utilization & tool administration
Coordinating idea management activities, periodically follow-up and reporting

174

Quality Specialist Resume Examples & Samples

Provide expertise in quality subjects
Analyze problems affecting the product safety and the consumer safety
Manage quality Incidents
Provide analytical problem management, from identifying risks, assessing risk, to resolving the problem
Actively participate in projects of cost-saving and innovation (Kaizen, CI)
Introduce innovative tools of quality system management and problem-solving
Cooperate with the production team and quality team
Conduct training on quality and hygiene, internal and external audits
Ensure compliance with systems and processes (ISO 9001, HACCP, FSSC - belt 96, GMP, Pest Control)
Manage documentation and complaints

175

Quality Specialist Resume Examples & Samples

To be responsible for the movement, control and tracking of documentation, ensuring a timely flow to adhere to the production schedule
Review and approve Material Specifications to ensure compliance with pharmacopoeia and client requirements
Review and approve Incoming Bulk, Intermediate and Finished Materials to ensure compliance with pharmacopoeia and client requirements
Review and approve Randomisations to ensure compliance with GMP and client requirements
Review and approve GMP information to ensure accuracy and compliance with company procedures
Review and approve Pre and Post Packaging Batch Records to ensure compliance with GMP and company procedures
Liaise with relevant department staff and management on quality issues and timelines
Review and approve observation and deviation reports to ensure compliance with GMP
Perform internal audits as scheduled and monitor / trend findings
At least 3 years’ experience of Pharmaceutical/Clinical Trials Packaging and GMP Processes
Excellent verbal/written communication skills
A high level of concentration and a good eye for detail is essential
The ability to prioritise daily/weekly workload
The ability to be decisive when required on material/product quality issue’s to ensure compliance

176

Quality Specialist Resume Examples & Samples

Build team and establish process for Documentation Review as per customer approved documents & to take up the issues with manufacturing
Prepare Quality Inspection Plans for incoming, in process & finished components, sub-assemblies and products
Establish process for inspection in the functional area
Establish and Drive QMS procedures regularly in line with GE QMS
Assist Manufacturing in investigations of process related quality issues
Develop & maintain Testing / inspection methods & create process routings
Participate in annual budget planning and drive execution for the quality function in the area, within business objectives
Drive EHS and compliance culture
Lead high impact process & quality improvement projects yielding significant reduction in defects & increased productivity in the Cell
Attend weekly cross-functional quality sessions & track / drive root cause analysis & corrective actions for Cell issues
Utilize lean-manufacturing principles & participate in action workouts to improve process capability, reduce overall costs, & increase capacity
Develop positive relationships and work closely with Shop team to manage and implement engineering changes, New Product Introductions, and transfers
Specify and develop product acceptance / test procedures that relate to a state-of-the-art process or new product
Deliver results as measured by key metrics such as cost of failure, yield, field cost, field defect rate, quality plan effectiveness, and corrective & preventative action closure
To ensure control of NC Products. To ensure identification / implementation of counter measure action for any defecting line Quality problems
Calibration activity of all Measuring and testing instruments at in-house and sub-contracting
Actively involved in Implementing daily work management and PDCA (Plan Do Check Act)
Develop & establish Shopfloor teams for the plant to deliver production as per business objectives
Bachelor's Degree in Mechanical or Electrical Engineering
Minimum 8 – 10 years in Quality function in Testing and Final inspection area in Loco build or similar industry type
Strong background in the interpretation of engineering drawings / specifications & manufacturing processes
Prepare Quality data like DPU, DPMO, Knowledge on FMEA
Excellent interpersonal skills with the ability to work closely with diverse team members
Ability to Review blueprints, plans, specifications along with manufacturing engineer and to incorporate the requirements into the Quality Plan / procedures
Having working experience of Oracle / SAP ERPs for Shop planning & execution
Knowledge of Regulatory requirements in Quality / inspection area
Demonstrated oral & written communication skills
Strong interpersonal & leadership skills, team building ability

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Quality Specialist Resume Examples & Samples

Bachelor's Degree in Mechanical or Production engineering
Minimum 8 to 10 years in Quality function in Heavy Fabrication Industry / in Loco build or similar industry type
Certified by ASME / AWS / API
Ability to Review blueprints, plans, specifications along with manufacturing engineer and to incorporate the requirements into the Quality plan / procedures
Aware on use of ERP system for data capture and as business processes
Knowledge on Welding processes, Welding Codes, on Quality parameters in Weld shop

178

Quality Specialist Resume Examples & Samples

Management of the Supplier Complaint process for the escalation and investigation of all supplied raw material and component complaints
Change owner for Supplier Change Controls with site impact and introduction of new suppliers
Monitoring and review supplier of Supplier quality performance and escalation issues to SQSS, procurement and Site Quality Council
Build relationships with Suppliers, identify improvement initiatives and drive quality plans to completion
Provide governance of the Site Change Control process
Deliver training associated with the Change Control and Supplier Assurance processes and mentor site personnel who generate Change Controls
Representative for GSK Maidenhead at the above site Wider Assessment Panel (WAP) for Change Controls
Act as host for Kosher and Halal audits
Perform Level 1 and 2 audits on site
Provide cover for Quality Specialist – Quality Systems and Quality Specialist – Regulatory roles
Ensure that GMP, quality, health & safety processes are adhered to in all aspects of the role
To demonstrate the key capabilities, behaviours and values as set out in the GSK Leadership Profile for “Managing Self”
Please note that this role is available on a fixed-term 12 month contract **

179

Quality Specialist Resume Examples & Samples

Responsible for intensively evaluating select retail products off the lines to monitor quality of products. Work closely with all departments (maintenance, production, R&D, purchasing) to identify and rectify any quality defects in products. Provides feedback to the site through regular communication and works to a decrease in customer complaints
Provide technical support to manufacturing and R&D as required to assess Quality of finished product. This could involve product testing as required
Investigate customer complaints and forward written response to customer service
Co-ordinate with outside warehouse to ensure product is dispositioned as per QA instructions in a timely manner. Monthly held lot report is issued to production and upper management. Report is used to track product quality KPI
Be aware of allergen issues that may affect Consumer Safety when entering formulas into SAP. Incorrect entry may cause wrong ingredients to be added and result in an allergen problem
Assist production in investigating Defective Materials and in follow up with suppliers
Responsible for communicating Consumer Safety issues so that prompt corrective action is taken
Support quality and food safety programs including HACCP and FSCC-22000
Knowledge of QA systems, microbiology, HACCP, GMP is critical
WCM and Certification in Acidified Foods Manufacturing is ideal
Demonstrated ability to support large-scale change activities

180

Quality Specialist Resume Examples & Samples

Minimum of 1 year working in a GMP production environment or prior quality control/assurance experience
Must be detail oriented and demonstrate good organizational skills to manage multiple tasks
Candidate must demonstrate good interpersonal skills
2-3 years’ experience in a GMP production environment, quality control/assurance experience

181

Quality Specialist Resume Examples & Samples

To take responsibility for analysing service/project data, ensuring any variances flagged up on Exception reports are investigated and action taken within agreed timescales
To produce required Management Reports as per agreement in terms of frequency and content standardization
Work closely with assigned business to ensure all improvements are driven correctly, provide feedback on on-going efforts & identify new areas of improvement
To provide GTS coordination for Problem & Change Management , for skill teams and IT Units
To take in charge of Production Service Management, quality and process, production reporting

182

Quality Specialist Resume Examples & Samples

Ability to understand complex Electro-mechanical assemblies
Good communication, listening and interpersonal skills
Able to resolve technical issues
Testing and development
Understanding assembly documentation & blue prints
Working knowledge of Microsoft office suite
Performing electro-mechanical tasks
Five to ten years working a quality technician/specialist in a manufacturing environment building industrial, electro-mechanical or commercial products

183

Quality Specialist Resume Examples & Samples

Coordinates and reviews data elements for all quality measures identified including data collection, analysis, and reporting, while identifying areas for improvement and then coordinating efforts to improve performance
Serves as liaison to corporate, statewide and national collaborative for quality and performance improvement initiatives
Serves as an adjunct for Joint Commission requirements, State of Readiness Committee (SORC) and Leapfrog surveys
Has familiarity with OPPE process
In collaboration with the Risk Manager, assists and/or conducts root cause analysis (RCA) which may include coordination of medical information, debriefing of involved individuals, performing cause and effect analysis, coordinating an expert panel review, root solution, and follow-up initiatives
Available by beeper at all times, during scheduled working hours
Demonstrates respect and regard for the dignity of all patients, families, visitors, and fellow employees to ensure a professional, responsible, and courteous environment

184

Quality Specialist Resume Examples & Samples

As a Quality engineer you will be responsible for the following activities
Define quality- and test strategies for products considering defined process and product standards
Create a detailed test design including test system landscape definition and product standards
Author functional Test cases based on requirements
Strive for 100% Automation using Automated Test scripts
Execute Manual Tests wherever Automation is not possible
Actively Participate in code reviews and other quality processes
3 to 6 years of experience in software Testing/Quality Assurance/ Development/especially in white box and functional testing
Bachelors or Master Degree in Computer Science Engineering or Equivalent
Experience working on Agile Methodology
Proficient in Manual and Automated Testing
Familiar with testing methodologies and strategy
Strong communication and problem solving skills
Highly Result Oriented and Agile
Self-reliant & creative problem solver

185

Quality Specialist Resume Examples & Samples

Keep management updated: Relay important information in the form of timely and accurate reports
Impact the bottom line: Produce solid and effective strategies based on accurate and meaningful data reports and analysis and/or keen observations
Strengthen relationships: Establish and maintain communication with clients and/or team members; understand needs, resolve issues, and meet expectations

186

Quality Specialist Resume Examples & Samples

Provides development of Quality Assurance Plan and the implementation of procedures that conforms to the requirements of the contract
Provides an independent assessment of how project's quality control processes are being implemented relative to the defined process and recommends methods to optimize the organization's process
Developing, tracking, and maintaining quality control metrics
Establishing and maintaining quality control standards, procedures, and processes
Experience conducting quality reviews of all products and providing periodic Quality training to ensure standards are maintained
Ensuring customer satisfaction through monthly check-ins with APMs, PAPMs, and the COR
Implementing immediate corrective actions when quality issues are identified
Providing continuous process improvement through process efficiency and monitoring

187

Quality Specialist Resume Examples & Samples

Monitors the appropriateness of patient care based on evidence-based outcomes and clinical guidelines
Maintains communications with clinical disciplines directly involved in the care of the patient, and aligns core measure requirements as necessary
Trains and educates nursing and medical staff in the area of data base requirements
Maintains knowledge through self-development, corporate compliance and training, and keeps current on all updates related to surgical and/or cardiac database requirements and best practices
Assists in the planning and implementation of interventions to ensure best practices are implemented for database compliance
Assists in the improvement of the accreditation process by verifying the accuracy of abstracted data, minimizing data calculation and aggregation errors and confirming that the data are as complete as possible

188

Quality Specialist Resume Examples & Samples

2 In conjunction with other management and supervisory staff, facilitate donor movement throughout the center minimizing donor wait time and processing
3 Supervise reception and medical work areas activities to ensure proper handling of supplies and materials. Coordinate plans and deliver medical and reception staff training
4 Repair or replace equipment in a timely manner. Update equipment status and documentation on a regular basis
5 Ensure adequate reception and medical staffing to provide sufficient support based upon center size, structure and donor flow. Create schedules for direct reports per company procedures. Monitor time card procedures, attendance and overtime usage
6 Conduct investigations, participate in root cause analysis, and develop recommendations for process improvement
7 Participate with management in conducting performance appraisals and providing performance feedback. With management review and direction, document verbal and written coaching level corrective actions, as needed
8 Participate, as appropriate, with management in the recruitment and selection of center operation staff
9 Act as liaison for Center Medical Director and Divisional Medical Director. Coordinate Center Medical Director activities
10 Follow and ensure staff adheres to all Standard Operating Procedures (SOPs), company policies and procedures
11 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIIPA, and OSHA
12 Participate in selected Center Leadership meetings and present pertinent related medical topics. Conduct and document monthly medical meetings
13 Ensure accurate recording of donor data in the electronic donor information management system as outlined in the SOPs
14 Provide medical oversight and guidance to center specialty and employee Hep B programs. Understand policies and procedures associated with hyper immune programs at the center, as applicable
15 Maintain clean efficient work environment, and ensure sufficient operating supplies and forms are available. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedures and documentation audits, as applicable. Promote safety in all actions
16 Maintain an environment free from harassment or intimidation of any employee by co-workers, management personnel or any external source. Immediately report (orally and/or in writing) all incidents of harassment to a manger and Human Resources
18 Will be cross-trained in all technical areas and other functions to meet business needs
Supervisory experience and regulated environment strongly preferred

189

Quality Specialist Resume Examples & Samples

You proved to be a strong communicator specially in English language both verbal and written with strong business acumen
The Ability to work under pressure and meet tight deadlines
Ability to adapt, accuracy and attention to detail
Portfolio of your published copywriting works will be presented on the application
Knowledgeable with Call Center Operations terminologies

190

Quality Specialist Resume Examples & Samples

Expertise in defining quality, and test strategies for products respecting defined process, and product standards
Analyze and decompose complicated software solutions and design strategies to test the system, both at the unit level and end-to-end
Creates detailed test design including test system landscape definition and product standards, prepares tests (customizing & master data), authors and executes manual and/or automated tests
Becomes subject matter expert for teams in terms of quality assurance and test related processes, methods and tools
Take ownership of product areas and drive the quality goals to help deliver world class On-Demand software solutions
BS/Masters in CS or Engineering degree
Deep proficiency in one or more programming language (Java, JS, Ruby, Python)
Demonstrated excellent skills with test tools and frameworks such as JUnit, TestNG, Jenkins and Selenium. Working knowledge of testing scalable web-services based on REST/XML/JSON
Proficient in Database concepts and hands on experience with PL/SQL
Familiarity in large scale business payment systems is a plus
Must be a quick learner and creative problem solver
Self-motivated and drive for success!

191

Quality Specialist Resume Examples & Samples

Ensure quality of manufactured goods
Inspect goods as they are finished
May examine materials from suppliers before sending them to production line
Inspect components, subassemblies, and assemblies
Perform quick visual inspections
Test, measure, and analyze products
May order materials
Ensure company is meeting the standard codes in the manufacturing process
Record pass/fail grade of products
May produce detailed reports

192

Quality Specialist Resume Examples & Samples

Highly knowledgeable in Western Union products and services
Ability to provide unbiased and accurate feedback in a professional way
High degree of problem solving and analytical ability
Ability to build effective partnerships at all levels

193

Quality Specialist Resume Examples & Samples

Audit and evaluate workflows, work methods, and procedures on an ongoing basis and initiate corrective action and process improvements where appropriate
Administrate and maintain the Quality Process / Quality System for assigned single or multiple sites including conducting local Quality Management and Business Process Review Meetings
Act as local quality representative and provide support for compliance reviews and audits
Serve as a quality and product technical resource for the location(s) regarding customer specific requirements and material specifications
Coordinate and respond directly with customers & suppliers regarding quality problems and audits
Maintain customer approvals for the location – support and implement customer requirements
Act as a facilitator for problem solving, corrective action, and quality improvement initiatives. Communicate actions to both internal and external customers
Maintain records and metrics on Quality Process for multiple departments and locations
Assure that employees receive required quality training and attain and maintain desired competency
Communication skills – verbally and written
Leadership ability – willingness and drive
Problem Solving Capability – analytical thinker
Computer Skills – Oracle Systems, BI / SQL Tools, MS Office Suite, Advanced Excel etc., Visio, MS Project
Quality Systems, Customer Quality Systems Experience 2-5 years
Understanding of AS9100 and ISO9001 Requirements
Knowledge and experience with monitoring and measurement tools
Drawing and specification interpretation

194

Quality Specialist Resume Examples & Samples

Assist in analyzing and solving quality and safety issues and perform process improvement projects
Set up and perform multiple quality tests, compile statistical data and prepare reports on testing results
Assist in coordinating the documentation for Corrective and Preventive Actions as well as customer complaints
Analyze quality costs (failure reviews, re-inspection, rework) and other quality data towards reduction of the total cost of quality
Perform internal audits as required to comply with ISO 9001 and OHSAS 18001
Prepare inspection plans and instructions to analyze trial products
Conduct inspections of facilities, work areas and equipment to ensure compliance with company, state, and federal safety policies and regulations
Ensure health and safety issues are owned correctly and escalated as required
A minimum of 2 plus years experience in quality in a manufacturing environment
Working knowledg of Quality Management System ISO 9001
Experience in problem solving techniques and work instructions
Proficient computer skills and knowledge of Microsoft Office
Possess good leadership abilities, organizational and communication skills

195

Quality Specialist Resume Examples & Samples

Experience in creating and analyzing reports to monitor and improve help desk support operations
Thorough knowledge of help desk ticketing software and Microsoft Office
Knowledge of troubleshooting strategies
Ability to manage multiple tasks and priorities and work effectively under pressure
Ability to handle sensitive and confidential matters in a manner that retains a relationship of trust
Ability to communicate effectively with people of differing levels of technical knowledge
Highly developed problem solving and interpersonal skills

196

Quality Specialist Resume Examples & Samples

Good problem solving and decision making skills
Interested in solving problems and courage to act, also independently
Active approach to work and eager to learn more
Good interaction and cooperation skills as you will work with different departments every day
Ability to communicate in English as we are in contact with Nestlé Nutrition and Nordic QA organization
Food industry degree e.g. Engineer, MA
Work experience especially from production/quality assurance
Good PC and MS Office skills, knowledge on SAP is an advantage

197

Quality Specialist Resume Examples & Samples

Design & write test protocols to meet requirements as defined in project scope
Stores test samples and distributes to the proper labs at specified time points
Occasionally completes tests per protocols as dictated by department workload needs
Provides reports and monitors test progress throughout the study to ensure adherence to project timelines
Trends and assesses data to track program effectiveness and proactively identify areas of risk
Participates in root cause analysis as applicable to stability program failures
Updates test protocols as needed to maintain regulatory requirements
Contributes ideas and suggestions to improve cell culture media manufacturing environment to enhance protocols, processes and equipment
Reports all non-compliance and support, engage in, and potentially lead teams assigned to making improvements
Demonstrated experience in the analysis and assessment of technical and/or stability data
Experience in Laboratory testing and methods
Strong written, verbal, and organizational skills, and the ability to work independently with cross-functional teams
High degree of proficiency in writing protocols and reports
Ability to work in a high paced team environment, prioritize multiple stability workflows and projects

198

Quality Specialist Resume Examples & Samples

Performs batch record issuance to the shop floor
Performs domestic and international batch release
Creates batch release protocols for international markets
Maintains metrics associated with batch release, batch record review and GMP walk through inspection
At least two years of relevant post-degree work experience in a quality, operational or technical function supporting manufacturing

199

Quality Specialist Resume Examples & Samples

Conducts on premise quality checks for a variety of randomly selected residential customer work orders recently completed by either in-house technicians or vendors ensuring company quality standards for product installation and repair are met
Accurately and objectively uses the quality application (Vantage) to review records, keep detailed notes, and take photos of defects found during the field visits. In addition, referrals and quality turnover work orders are entered, including all relevant information, in order to support other groups in a speedy and thorough resolution
Conducts repairs of all defects noted while on site to bring the customer’s wiring and Cox services to National Quality Standards and safety requirements
Positively and professionally interacts with the customer to gauge the recent experience, informing the customer of the Quality Check process, answering any questions the customer may have, and providing assistance where needed
Tests drop cable and configuration through a variety of systematic Radio Frequency (RF) validation protocols, checking for ingress and drop failure points
Ensures an accurate product match, based on the customer’s current service level, and that the overall aesthetics of the job meet requirements and are pleasing to the customer
Activities include completing checks for measuring quality of work completed on residential video, phone, audio, data and wireless work orders. This will include validation that all workmanship and signal levels meet specifications, and that all services are working correctly
Manages CPE needs either by maintaining inventory in the vehicle or by coordinating with the Comm Center, based on leadership direction
Reviews and responds to requests for product and service repair or trouble resolution during quality assessment
The environments that the work occurs in include, but are not limited to: residential homes, apartments, and retirement communities. As such, it may require that work be completed in basements, crawl spaces, and attics, as well as to the interior or exterior of the buildings
Professional and productive interactions are expected with current and prospective customers, property managers, and the public
Collaborates with Cox Communications team members and boundary partners to fulfill tasks and ensure any defects are corrected
Operates a vehicle safely, in a manner which reflects positively on the company image, and in compliance with the law. All vehicle operation must comply with the most current company vehicle policy. Items within the vehicle must be stored safely, securely and in an orderly manner
Equipment handled and used for access while performing the tasks includes, but may not be limited to: step ladders, extension ladders, and step poles
Frequent lifting of up to 50 lbs. and occasional lifting of up to 75lbs. is necessary to successfully complete the overall tasks associated with this position
Manual tools used while performing tasks include common hand tools (e.g., screwdrivers, wrench, pliers, hammers, fish tapes, saws, etc.) that require squeezing, prying, twisting, pushing and swinging
Motorized tools to drill, punch, pull or drive screws, and vacuum are commonly used
Operates test equipment to verify proper performance of products and the delivery networks. Such equipment includes: RF meters (power, purity, and interference), RF leakage detectors (shielding integrity), telecommunications test equipment (call progress tones, signaling and audio), Twisted Pair metallic testing equipment (performance and connector assembly), fault detectors (cabling assurance testing), and other supplied testing tools to ensure reliability and product performance. On occasion, the use of optical testing equipment (optical delivered signals) may be necessary
Protects the company assets from loss, theft, and damage. Maintains an accurate inventory and tracking of assigned inventory. Provides accurate reporting for incidents that occur
Protects the company’s intellectual property (e.g., processes, plans, budgets, records) from unauthorized access, theft, or duplication. Follows the data security processes to the highest degree possible
Reports all unsafe situations to leadership for assistance in resolving or reporting unserviceable locations
Uses software tools for labor, test, measurement, performance, and costs must be in a timely and accurate manner
Performs tasks with a high degree of quality and accuracy and completes them correctly on the first attempt to ensure proper, reliable performance of products and prevent disruption of customer service
Works with a high level of integrity avoiding conflicts of interest
Maintains strong knowledge of product features and function, as well as latest methods and procedures for delivery, including back office workflow tools for task assignment
Provides timely communication to all groups (including customer) of progress of work, change in task durations, and unexpected changes in work completion
May require some travel
Autonomously and efficiently maintains personal productivity and performance to maximize the number of quality checks performed in support of reaching in-house and vendor completion goals, as well as meet or exceed performance metrics as defined by the national quality program
May be required to pass additional background screenings as required by law or in general to perform role
Other duties as assigned to support the completion of the department’s work
2 or more years of experience in a related field (i.e., technician working in the field supporting video, voice or data products)

200

Quality Specialist Resume Examples & Samples

Involved in trace and recall procedures
Support traceability exercises
SAP/GLOBE QM Super user- responsible for learning, implementing, teaching, maintenance and reporting data from the
Supports Improvement initiatives (e.g. complaints, holds) with Factory, and drives improvement projects in DOR
Assist, advise and train Operations in attaining the Nestlé quality standards (QMS, MI, etc.)
Communicates Quality and Food Safety briefs to assigned line operation teams. (Is this the Quality Specialist, or the
Preferably 2-3 years manufacturing and or laboratory (1-3 years) experience in food industry
Knowledge of continuous improvement
Must be able to handle multiple assignments
Must be able to perform in a demanding, fast-paced environment
Proficiency with computer systems, personal computers, spreadsheet software (Microsoft Office, etc.) and mainframe
Results Focus: the drive to meet or exceed ambitious performance objectives and quality standards, deliver business

201

Quality Specialist Resume Examples & Samples

Audit the quality and food safety systems and facilities of suppliers, specific contract manufacturers, brokers, boutiques, food suppliers and warehouses to Nestlé USA, Nestlé Canada and Nespresso USA and ascertain their compliance level to provide safe food and adherence to local regulatory requirements
Perform qualifying audits for potential new suppliers to support business opportunities and needs. Coach and educate those who accompany the auditor. Identify appropriate corrective actions to the companies being audited and inform the appropriate Nestlé parties
Travel extensively to on-site vendor locations; perform on-site assessments as required to determine corrective actions or new opportunities
Review Third Party Audit Reports for Food Safety & Quality Management Systems to be used as a basis for supplier approval
Audit Report writing; clearly document audit results and findings in approved formats
Use GLOBE VAM system to report audit findings and gap closures
Develop and communicate monthly scorecards and performance improvement results to Central Audit Manager and Quality Director
Coordinate audit schedule to minimize costs and improve efficiency
Follow-up on corrective actions to achieve compliance to audit gaps
Other duties related to audit function; team meetings, operational reviews, projects, assigned to manage opportunities for improvement (OFI) with key impact suppliers to drive vendor performance and continuous improvement
Communicate significant deficiencies to the appropriate Divisional QA Director/Procurement/Director Supplier Management, etc
Nestlé Quality Leadership training or equivalent – desired
Minimum 7 years food-related quality assurance experience and in-depth understanding of
Food Safety & Quality Management System processes and procedures; implementation and auditing
Hazard Analysis, Validation & Verification of PRP’s and Control Measures and HACCP plans
Excellent interpersonal and self-initiative skills
Systems thinking, problem solving and analytical skills
Strong verbal / written communications skills
Plan and organize work effectively, detailed and results oriented
Proficient in the use of MS Excel and Word, PowerPoint and SAP (desired)
Ability to work individually and be able to work effectively in a team environment

202

Quality Specialist Resume Examples & Samples

SAP/GLOBE QM Super user- responsible for learning, implementing, teaching, maintenance and reporting data from the GLOBE QM module of SAP
Support for all outside warehouses
Supports production in decisions related to quality and food safety
Conducts coaching and training to employees
Identifies gaps in procedures or processes
Responsible for changes in procedures and QMS
Manages Foreign Bodies Task Force
Daily Review of HACCP documentation on Shop Floor
Daily Behaviour Based Quality observations
Responsible for follow-up activities driven by CPARs from Internal Audit Team and Third Party Audits
Members of Internal Audit Team
Able to work flexible hours and able to cover off shifts
Interprets data and reports on trend and data analysis to appropriate personnel
Organizes laboratory records and files, summarizes data, and prepares and interprets reports for use by management. Reviews or writes procedures and work instructions
Supports laboratory activities to ensure a high quality of products, services, housekeeping, and hygiene standards are maintained and improved in laboratory and other analytical areas
Responsible for daily equipment maintenance, ordering, stock control, stock record entry, reporting, etc
Assists, advises, and trains colleagues to attain the NQAC requirements (MI, LI, P-test, etc.)
Ensures that a high quality of products, services, housekeeping, and hygiene standards are maintained and improved in designated areas
Communicates Quality and Food Safety briefs to assigned line operation teams. (Is this the Quality Specialist, or the Food Safety Team?)
Ensures compliance with all regulatory and Nestlé guidelines pertaining to safety, health, and environmental

203

Quality Specialist Resume Examples & Samples

A minimum of 1-3 years’ experience in Quality Control
A minimum of 1-3 years’ experience with Microsoft Excel
Experience in beverage or beverage alcohol is a plus
Lean Manufacturing techniques a plus
Experience with developing/documenting procedures/methods
Experience working with high performance teams
Experience with Hazard Analysis Critical Control Points (HACCP) and ISO 9001 & 22000 a plus
Strong chemistry and mathematical skills are required
Analyze statistical data to establish quality of finished products
Provide technical support to teams
Quality orientation and high attention to detail
Effective verbal and written communicator, to include interaction with internal and external customers
A working knowledge of TTB regulations, ISO requirements and Food Safety processes to include HACCP
Must have strong analytical skills
Must have the ability to multi-task in a high speed manufacturing environment to meet production demands
Problem solving skills, attention to detail and customer service orientation are essential functions of this role
Physically able to navigate a plant/production environment – including the climbing of stairs, elevated walkways etc
Read and analyze available data
Willingness to work independently on off-shifts, weekends and holidays, as necessary

204

Quality Specialist Resume Examples & Samples

Reviews Customer Complaints and Return Authorizations and makes recommendations regarding further actions (i.e., Corrective Action Request)
Researches internal and external customer complaints and prepares statistics for monthly reporting and/or Corrective Action follow up
Actions or assists with customer documentation requests and distributes company profile information
Works with all departments to implement corrective actions for customer complaints
Works with suppliers and freight carriers to implement Corrective Action Requests
Works with other divisions to process Supplier Corrective Action Requests (SCARs); collection information for reporting and closure within the Supplier Program per procedures
Distributes external announcements from customers to internal personnel and maintains customer correspondence files
Other tasks as assigned by the Department to include participation and input in QRT and Management Review meetings
Demonstrates technical proficiency and self-assuredness in applying quality concepts
Provides quality skills and knowledge to all departments when developing quality policies and procedures
Ensures all documentation produced is in compliance with ISO 9001 and internal procedures
Responsible for supporting internal and external audit efforts within the scope of this job description i.e. Customer Complaints, CAPA, etc
Responsible for monitoring the effectiveness of root cause identification and corrective action programs for preventative actions and customer complaints
Works with suppliers and freight carriers to implement corrective actions
Responds to external requests to quality documentation
Is knowledgeable in the understanding of all EH&S policies and procedures in association with department specific responsibilities
Support the Company’s commitment for EH&S by following ISO 14001
Associates or bachelor’s degree required
5-10 years’ experience working in a quality critical environment with a certified Quality Management System (ISO 9001)
Experience working in or closely with Warehouse Operations, Quality Systems or other highly focused customer roles
Position requires high level of concentration, close attention to details, and ability to multitask
Must be able to learn, on the job, adapt to changes and become proficient quickly
Must be especially responsive to customer requests and display a courteous and professional demeanor at all times
Ability to work at all levels within the organization and the ability to work in diverse work groups
Must be able to exercise discretion and good judgment
Strong attention to detail and possess the quality of being precise
Must reflect the goals and philosophy of the corporation in all actions and decisions made
Organizational and prioritization skills
Ability to construct and carry out plans within given timetables
Must have experience with Microsoft Office including Excel, Word and PowerPoint and be able to use proficiently

205

Quality Specialist Resume Examples & Samples

Handling and investigating Customer Complaints 20%
Monitoring non-conforming Raw materials system and corresponding with suppliers in regards to corrective actions. 20%
Monitoring Deviation system 20 %
Internal Audit coordinator 10%
Corrective and Preventive Actions 20%
Monthly trending of quality data 5%
Annual Product Reviews 5%

206

Quality Specialist Resume Examples & Samples

Perform final QA review and release for all shipments and associated documents, to ensure shipment meets customer specifications
Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information
Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action
Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information
Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used
Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management
Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation

207

Quality Specialist Resume Examples & Samples

Support the site supplier quality program to ensure effective supplier relationships and consistent quality of inbound raw and packaging materials
Serve as site lead auditor and coordinate all types of auditing required to ensure sustainability of the Quality Management Systems
Respond to Customer Complaints and Quality Holds with data collection, problem solving, and root cause analysis. Support the Food Safety Team including the maintenance, and auditing of Food Safety Plan and prerequisite programs
Maintains all quality records, reviews all preventive control records within 7 days and upholds compliance with regulatory requirements
Communicates all out of specification micro results and assists with management and disposition of any non-conformances. Participate and champion continuous improvement at the site including all proactive quality tools
Populate and communicate weekly housekeeping scores. Input and develop data upon which prioritization of corrective actions can be made. Communicate findings to plant management and shop floor (written reports & oral communications and presentations)
As required, provide site–wide and individual training. To support quality improvement activities, provides technical support, directional data and analyze data results
Coordinate and conduct special sampling regimes as needed. Member of the daily taste panel
Support of the site quality process and lab include, effective communications (written & verbal), clerical (filing, file maintenance, copying, distribution & updating of documentation, record retention), administrative (document preparation, presentations, form preparation, e.g., requisitions, purchasing orders, faxes, and the organization of files), troubleshooting, report writing, and data analysis
Manage uniform program, scale calibration, and pest control program
Team involvement includes support of site quality teams, membership on cross-functional teams to set or change standards/procedures (may include: corporate, marketing, plant), intra-departmental shared work and back up responsibilities for department members as needed

208

Quality Specialist Resume Examples & Samples

Support internal and external audit process
Coordinate the development of action plans when corrective actions (CAPA) are required
Author and/or review batch records (BR), Standard Work Instructions (SWI), Client Work Instructions (CWI), Material Specifications, Standard Operation Procedures (SOP), Validation Protocols
Supports the continued development of GMP capability and maintenance of compliance to US FDA Quality System Regulations
Assist in overall GMP strategy, best practices, and guidance across multiple GMP sites
Extremely adept in attention to detail/follow up

209

Quality Specialist Resume Examples & Samples

Performs batch release of products he or she supports
Collaborates with Plannng, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates
Assists in sending samples/lab reagents to release authorities
Completes required SAP transactions to release product in SAP
Completes, reviews and sends release protocols to regualtory agencies
Performs 100% audit of process documents / log books to ensure completeness and accuracy for assigned IPT
Prioritizes document review to ensure alignment with product release due dates
Maintains any tracking databases and logs associated with this review
Provides coaching and mentoring of manufacturing supervisors and operators completing documentation
Coordinates with Production to discuss, resolve, and eliminate documentation observations
Performs SAP transactions required to document Batch Recoird Review
Ensures proper identification of release status and control of materials through maintenance of quarantines in SAP and through physical tagging of material as required
Performs Quality review / approval of new and updated SOPs and CJAs
Collaborates with IPT members to investigate deviations on production floor during shift
Works with necessary groups within the Focus Factory to resolve outstanding issues with process documents / log books, GMP walk through inspection observations and quarantine, management
Reviews Emergency Stamps / hand Stamps entered into the batch record
Performs Quality review of new and updated Master Batch Records
At least three years of relevant post-degree work experience in a laboratory, manufacturing, or quality position Or as a consultant providing support in one of these areas
Attention to detail, flexibility and an awareness of production and attendant quality control problems
Familiarity with manufacturing batch records and release of product is a key skill necessary for success in this position; prior batch record and release experience is a strong plus
Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is a strong plus

210

Quality Specialist Resume Examples & Samples

Conduct ISO compliant audits to ensure contractual compliance with established requirements
Rearrange and take inventory of stored materials, examines stored materials and reports deterioration and damage
Generates and presents audit findings to senior management. Generates audit reports and validates actions taken adequately address documented findings
May conduct unscheduled audits, participate in investigation teams and assist in external audits as requested by senior management or the customer
Attends and participates in a variety of meetings and task force groups to integrate activities, communicate issues, obtain approvals, resolve problems and maintain specific level of knowledge pertaining to new developments, requirements and policies
Bachelor’s degree in related field and three (3) years experience or equivalent
Good communication and analytical skills; working knowledge of computer systems and integrated software application programs. Position may require the ability to pass and maintain a security clearance

211

Quality Specialist Resume Examples & Samples

You work as a tester in an agile development team according to Scrum
You contribute to the definition of tests within our Cloud Solution
You will take care that our Cloud solution will achieve the next level of quality
You have the chance to continuously enhance your knowledge and keep up with latest technology trends
Very good Bachelor degree or above in Financials, Computer Science, Information Systems, or related disciplines
Excellent end user experience in Finance Solutions
Excellent team player with a strong ability to network and with drive for tangible results
Very good assertiveness to secure that our software achieves the highest quality standards
Fluent English and German

212

Quality Specialist Resume Examples & Samples

University degree or equivalent education background
Solid experience in test-driven development, unit testing, functional testing, system integration testing and regression testing
Experience with several testing algorithms and automation frameworks
Thorough knowledge of all aspects of non-functional testing approaches and tooling
Experience testing highly available, high throughput, distributed systems deployed in the cloud
Understanding of Microservice architecture and SaaS
Familiarity with the commerce domain
Ability to adapt quickly to new challenges and an evolving technology stack
Cloud Foundry
AWS
Bamboo /Jenkins
Knowledge of the SAP Hybris product portfolio

213

Quality Specialist Resume Examples & Samples

Responsible for development focusing on design, coding, testing, quality assurance of complex product features in a development team. Resolves complex issues within own area of expertise and supports others in resolving issues
Shows initiative and drives topics to resolution in a high level of quality, speed, reliability and efficiency
Works closely together with others and shares expertise to ensure product success
Quickly develops advanced overall product and technical knowledge and shares expertise within and across team and organization
Has advanced knowledge of development processes and product standards
Technology experience - Java,
BTech CSE or equivalent

214

Quality Specialist Resume Examples & Samples

Master degree in Sciences / Engineering / Pharmacy / Bio Engineering
Minimum 5 years of experience in a pharmaceutical / biological environment
Strong knowledge of cGMP and cGDP regulations and guidelines
Strong knowledge and expertise in quality systems, e.g deviation, CAPA, training, change control, documentation, validation
Demonstrated good communication skills, impact and influence
Excellent French and English knowledge, written and spoken
Actively collaborating with the Business Bartners to align on the processes, procedures and practices for the distribution of GSK Vaccines
Managing (as a QA approver) according to procedures and in a timely manner, global deviation/unplanned events ensuring proper product disposition/recommendation, root cause analysis and definition of associated CAPA. In scope are deviation/unplanned events occurred during worldwide distribution to customers and during inter-sites shipments
Performing global trends analysis for Global Distribution in GSK Vaccines in a timely manner. Ensure that defined actions are followed and closed as needed
Play a key role within Quality for Distribution and Cold Chain team to put in place the defined strategy and oversight model in the distribution network (including secondary distribution)
Managing distribution oversight model for GSK and non GSK customers by ensuring all the needed actions are implemented or by approving the associated change control (including e.g. distribution risk assessment approval, audit/visit performed, Quality Agreement established)
Assessing in a timely manner any market complaint potentially related to distribution
Supporting distribution centers during external inspection for distribution incidents and associated topics
Following and supporting as required that the GMP/GDP training packages/GDP education documents are up to date accordingly
Providing education of Business Partners accross the GSK Worldwide Network in terms of training/education of quality requirements
Pro-actively identifying any potential quality and compliance risks related to distribution
Defining and managing, in a timely manner, internal audits and self- inspection plans in the Operations and Planning Distribution teams
Related to GDP Responsible Person deputy: Be the deputy of the GDP Responsible Person as needed (e.g. approving deviations, CAPA, market returns, oversight of Wade operations, inspection readiness,..)

215

Quality Specialist Resume Examples & Samples

Design efficient automated workflows and processes for labeling control based on analysis of existing label-content data drivers and change management systems
Provide guidance on labeling control requirements and champion labeling control process changes across the organization
Remediate/close gaps with existing labeling control processes
Develop the labeling control system for managing and governing internal and external (supplier) labeling
Draft and implement policies, procedures, and work instructions and administer related training for the labeling control system
Foster close cooperative relationships with all functions in the company relative to labeling compliance. Work with Product Development, Legal, Marketing, Quality Assurance, and Regulatory Affairs to support product labeling plans and strategies
Partner with the Information Technology function for administration of, and changes to, label templates, label printers, label barcode verification scanners and related software
Recommend changes to labeling systems and software and prepare specifications to support the changes
Additional labeling / organizational responsibilities as required
Demonstrated ability to work with people in an effective and positive manner
Food and Drug Administration (FDA) regulations and guidelines
5+ years related experience in an FDA regulated environment (medical devices experience preferred)
3+ years related experience as a subject matter expert for developing, implementing, and managing a quality system or function (labeling focus preferred)
Experience with Agile PLM, Oracle ERP, and/or BarTender software preferred

216

Quality Specialist Resume Examples & Samples

Lead / Coordinate Technical Acceptance activities between TAG, IQM and NDC
Work with IQM and Nestle Professional TAG leadership to define and implement pHACCP and pQMS processes for Nestle Professional TAG
Develop and maintain pHACCP templates for various factories / processes that manufacture Nestle Professional products
Work with receiving factory QA on new raw material, new equipment (TAG-related only) and / or new process risk assessments
Participate in Food Safety Team activities for NPCIC
Evaluate Nestle Professional products for potential product claims, and maintain records for raw materials associated with products that have claims (gluten free, vegan, etc.) Work with Nestle Professional TAG, Regulatory and IQM on implementing or maintaining product claims, as needed
Assist in investigation of customer complaints related to Nestle Professional products, as a technical resource for factory QA and factory Operations, and make recommendations for raw material specifications or process changes to prevent re-occurrences, when relevant
Investigate customer questions and provide Technical information to Marketing, Sales, Customer Service or Customers, as requested
Other Technical Support activities, as assigned
Knowledge of HACCP and Basic Food Safety Practices
Strong project management and organizational skills are necessary, as well as good communication skills
Candidates must be able to thrive in a fast-paced environment, adapt easily to changing project needs and demonstrate success in production facility environments
The individual must have good creative, problem solving and organizational skills, and able to successfully complete multiple, simultaneous projects requiring short timelines
Market/competitive activity knowledge
Ingredient knowledge
Corporate structure and systems knowledge
Understanding of business acumen
Coaching & development in production and/or corporate settings

217

Quality Specialist Resume Examples & Samples

Ensure approved quality systems are established and maintained
A minimum of 5 years related experience preferably in a FDA regulated industry
Experience in Canadian, EMEA or Latin American regulated regions desired
CQA certification desired
Demonstrated record of successful interaction with senior management, regulatory agencies (e.g. USDA, FDA) and other internal and external auditing groups
TECHNICAL SKILLS REQUIREMENTS
Strong interpersonal and communication skills; ability to communicate across all levels of the organization
May contact vendors and/or external customers for administrative and technical information
PC literate with the following applications: MS Excel, Word, Access

218

Quality Specialist Resume Examples & Samples

Audits and analyzes data where quality of work produced is poor or erratic
Initiates or recommends changes
Inspects and accepts or rejects all purchased gages or gauging equipment
Repairs gages and certifies results when required
Lays out parts using advanced mathematical calculations and precision
At least 1 year of previous experience in a Manufacturing environment
Work in an environment with frequently changing temperatures
Walk, squat, and bend over for intervals at a time
Strong commitment to safety and quality
Ability to perform basic math and simple computer operations
Forklift License

219

Quality Specialist Resume Examples & Samples

Inspects and accepts or rejects all purchased gauges or gauging equipment
Repairs gauges and certifies results when required
Previous experience in Operations

220

Quality Specialist Resume Examples & Samples

2+ years of experience within a Healthcare setting
Microsoft Office/Suite proficient (Excel, PowerPoint, Word, etc.)
2+ years of experience in Quality-related activities
Experience with HEDIS, HCC, and PCMH
Knowledge of utilizing Electronic Medical Records systems, such as EPIC

221

Quality Specialist Resume Examples & Samples

Consistently exhibits behavior and communication skills that demonstrate DaVita Medical Group's commitment to superior customer service, including quality, care and concern with each and every internal and external customer
Uses, protects, and discloses DaVita Medical Group patients’ protected health information (PHI) only in accordance with Health Insurance Portability and Accountability Act (HIPAA) standards
O Collects data, analyzes and generates reports and program evaluations for the Quality Department
3-5 years of previous healthcare administration experience
2+ years of quality management or delegation oversight experience
Knowledge of CMS and NCQA standards and requirements
Must have strong analytical and critical thinking skills
Must have strong demonstrated project management skills and attention to detail
Excellent organizational, professional, interpersonal, written and verbal communications skills
Ability to work independently on projects, while also working as a team member
Competent in use of MS office programs including Word, Excel, Visio, Outlook and PowerPoint and Adobe Acrobat to prepare documentation for audits and/or presentations

222

Quality Specialist Resume Examples & Samples

Manage distribution of Good Manufacturing Practice documents (e.g. methods, procedures, logbooks…)
Generate monthly Key Quality Indicators (KPIs) related to documentation and training
Maintain the Microsoft SharePoint's owned by the department
File and archive documents owned by Quality Assurance (e.g. training records, Good Manufacturing Practice certificates, etc.)
Clarify deficiencies in Good Manufacturing Practice documents with the line unit experts in own responsibility
Collaborate with other associates to support the service function of Quality Assurance
Participate in knowledge exchange in Quality Assurance and associated line function

223

Quality Specialist Resume Examples & Samples

Knowledge of problem solving tools and methods, including statistics, combined with the ability to select and apply them to make data based decisions to sustain higher levels of process or product quality
Possess an understanding and working knowledge of National and International Standards (e.g. ISO). Has sufficient knowledge to apply reasoning to the interpretation of the requirements
Ability to use proven tools, techniques, and methodologies to inspect products, measure process performance, perform product verification and validation testing, and to provide feedback reporting as required
Ability to strategically define the Critical to Quality elements of a product/process, and the knowledge to effectively analyze, assess and mitigate the risks associated with any potential failures
Ability to efficiently and effectively assess performance, set strategy aligned with the business and use metrics to drive continuous improvements
0-5+ years of experience in manufacturing environment
Prior experience in quality and continuous improvement tools and techniques
Six Sigma Certification
Quality and continuous improvement leadership
Ability to use statistical software (e.g. Minitab)

224

Quality Specialist Resume Examples & Samples

BS or BA in a science related field of study or extensive laboratory/brewery and/or process experience (Chemistry, Biochemistry, Cereal Science, Microbiology, Food Science, Agronomy, and Chemical Engineering preferred)
Advanced degree or certificate in brewing or quality related processes (e.g. IBD, CQE, Six Sigma) a plus
Six Sigma Certification preferred
Two (2) to four (4) years experience in quality related processes
Demonstrated use of advanced problem solving tools
Process or packaging lab experience as appropriate highly recommended
Advanced knowledge of laboratory equipment, instrument maintenance, calibration and trouble shooting
Advanced knowledge of statistical methods and computer skills
Advanced knowledge of continuous improvement concepts
Thorough understanding of brewing or packaging as appropriate
Thorough knowledge of quality systems, MillerCoors Manufacturing Way, quality at source, sanitation, aseptic processes and MillerCoors HACCP requirements
Thorough understanding of MillerCoors quality requirements for packaging, distribution and brewing as related to product quality specifications or equivalent
Awareness of OSHA regulations, GMP, state agricultural practices/policies, TTB regulations, plant safety regulations, FDA guidelines for food plant operations and environmental regulations regarding manufacturing brewery operations
Knowledge transfer and technical training skills across all levels of the organization

225

Quality Specialist Resume Examples & Samples

Perform QA audits of scientific reports/data to ensure cGMP compliance in preparation for release of the reports to the customer
Develop, implement, and revise procedures (SOPs, Methods, etc.) Conduct investigations and internal audits of quality systems
Review equipment and software qualification and validation protocols
Participate in client audits and regulatory inspections by escorting auditors and securing requested
Designs and plans audits of simple quality systems for review with QA Mgmt
Conducts employee training sessions as necessary documents and data
BS degree in chemistry or other related scientific field
Demonstrated proficiency in oral and written communication skills producing effective interaction with others at all levels

226

Quality Specialist Resume Examples & Samples

Use of Quality improvement tools and techniques to identify value-added opportunities
Accountability for anticipating problems and taking proactive steps to minimize risks and exploit opportunities
Performing audits and reviewing Quality performance and trends
Assures corrective action is coordinated with and communicated to all interested parties
Preparing and publishing Quality performance reports
Providing training for personnel relative to Quality Management
Working in partnership with interested parties to ensure proper completion of audits, reviews and other responsibilities as assigned
Communicating proactively with CAE management and other respective departments
Monitoring and reporting Quality metrics and key performance indicators
Selection, interpretation, and application of the Seven Basic Quality tools
Ensure assignees take immediate corrective actions to rectify any Quality issues
Ensure corrective action plans are created and submitted in a timely manner
Verify corrective actions taken are effective
Interpret basic control chart concepts, including centerlines, control limits, out-of-control conditions
Technical Degree or equivalent work experience
Current ASQ Certified Quality Auditor (CQA) or ASQ Quality Improvement Associate (CQIA) certification preferred but not required
Experience with aviation training operations and support is preferred
Ability to deal with complex issues and resolve problems quickly under pressure
Ability to conduct meetings and make presentations to executive leadership
Strong analytical skills and experience using metrics to measure Quality performance
Experienced with applying Quality tools and techniques
Proficient with Microsoft Office (Excel, Word, Power Point, MS Project, Visio)
Must exhibit a high level of motivation, sense of urgency, attention to detail and energetic approach to job duties and requirements
Ability to calculate amounts such as prices, commissions and percentages
Ability to create and interpret graphs and charts
Ability to work on the manufacturing floor and to assent into a simulator cockpit
Ability to lift a maximum of 50 pounds
Ability to sit and stand for extended periods of time
Focused visual concentration or focused listening

227

Quality Specialist Resume Examples & Samples

Assure that quality assurance standards and documents are communicated and enforced by conducting and auditing all quality training
Assists the Quality & Process Manager with the ongoing assessment and leadership of activities associated with plant quality control and sanitation programs ensuring that the plant meets quality, cost, delivery, safety and engagement objectives
Internally audits all quality control and sanitation protocols to ensure compliance with corporate and regulatory expectations
Prepares written documents describing analysis techniques and test results; writes SOP’s and other quality documents and reports
Verify compliance with established SOP documentation, GMP’s, HACCP and Safe Quality Food (SQF) efforts
Assists with maintaining regulatory compliance for food safety programs (i.e. HARPC, SQF) and appropriate pre-requisite programs (i.e. traceability, hold and release, metal detection, foreign object controls, sanitation, and allergen)
Participates in process improvement projects, documentation, and scheduling of plant food product trials
Participates in quality meetings and training
Supports the assessment and management of the Food Safety Plan (HARPC)
Ensure calibration and maintenance of lab instrumentation
Updates sampling plans
Communicate routinely with Quality & Process Manager and plant leadership, identifying opportunities for improvement, training and quality assurance program goals or barriers
Follows and enforces standards for food safety and food quality production reflected in SQF as well as the regulations of major vendors and governmental agencies such as OSHA, FDA and EPA and assures associates are consistently trained in these standards and comply with all requirements
Performs special assignments as directed
Associate’s Degree in Food Science, Quality Assurance, Business or a related field or equivalent work experience; Bachelor’s Degree Preferred
Three years of progressive work experience in the food manufacturing industry management experience, preferably in the quality assurance function
Requires working knowledge of food safety and food quality standards, regulations, and laws governing the food production industry such as SQF and environmental safety regulations along with a commitment to continuous improvement
Knowledge of regulations of major vendors and governmental agencies such as FDA, OSHA, and EPA
Ability to effectively present information to top management

228

Quality Specialist Resume Examples & Samples

Assists in establishing, promoting and coordinating lines of communication between the customer, sales representatives, suppliers and division personnel
Interacts with customers, suppliers, vendors and division personnel regarding quality and production issues. Attends job production pre-planning meetings
Evaluates the input material on a job and guides the customers, helping them deliver material that will produce a high quality job
Performs press color approvals for both internal and external jobs
Assists in the development of procedures and techniques for reducing process variation and manufacturing delays
Assists manufacturing personnel in establishing standards of quality to be used and certifying that established company and industry standards have been met. Evaluates process output and supplied materials for compliance with established standards
Communicates with sales, customer service and the customer to resolve quality issues
Negotiate resolution of customer or manufacturing complaints
Assist in creating and maintaining the statistical process control program
May be responsible for ISO programs within the division. Duties include reviewing documents, preparing for audits, conducting audits, following up on implementation issues and training as it relates to ISO
Collect and interpret test data, perform final testing to ensure reliable design test methods and protocols are met
Sets timetables and milestones for assigned design test, project tasks
Performs other EHS related duties and participates in special projects as assigned
Performs other related duties and participates in special projects as assigned
1) Bachelor degree in discipline related to functional work or role with 3-5 years of relevant work experience OR demonstrated ability to meet the job requirements through a comparable number of years of applicable work experience
2) Able to demonstrates ability to solve somewhat more complex problems by analyzing variables and applying appropriate solutions learned through experience and proficiency in understanding the job. Must be able to recognize anomalies and critical situations and respond appropriately
3) Must be able to communicate and interact with a variety of internal/external customers and/or co-workers at level of detail required to resolve issues of moderate complexity
4) Able to apply strong functional computer knowledge in utilizing Microsoft Windows, MAC, or other technical tools in completing assignments. May require knowledge of or ability to quickly learn specialized software to complete work assignments
5) Able to demonstrate continued expertise in the primary tools or applications used in completing daily work assignments
6) Requires very good communication skills with ability to state messages in a clear manner by using language that is easy for others to understand
7) Must be able to proactively listen to others to understand issues and situations
8) Must be able to clearly articulate business needs to both internal and external customers
9) Strong knowledge of printing and color theory

229

Quality Specialist Resume Examples & Samples

Provides expertise in the field of Quality processes, team objectives, Quality standards
Act as a technical advisor for quality first level managers, different stakeholders of other functions on process while maintaining a close partnership with Qualities Leaders.Sharing your knowledge of Quality processes, you will support the development of Quality manufacturing strategy and will help facilitate communication between business units, projects and processes
Help to identify best practices from different sources to find value-added opportunities for the Quality community, inside of our Achieving Excellence System. Be required to do benchmark on problems encountered in Quality process, identify opportunities and solutions proactively
Act as a mentor with your customers (quality management and employees) in change management. Coordinate various stakeholders within the Quality group, business units and central functions if necessary
Ensure Quality harmonization in the various projects and act as an advisor to assist the project team, if necessary
Work effectively with a diverse team (Quality Assurance and Quality Support), guide and support project team members Build strong relationship with the entire Quality group members (director, managers and supervisors)
You have previous experience in aircraft manufacturing/maintenance environment (technical experience is required)
You have experience in managing effectively unionized and non-unionized employees
You have the ability to work with minimum supervision, be a team player, self-motivated, and demonstrate initiative as well as leadership, and good interpersonal skills
You are able to work under pressure and manage multiple priorities
You possess workshop animation and negotiating skills and you are rigorous in monitoring
You possess knowledge of project management concepts
You possess knowledge of aviation regulations
You possess good oral and technical writing skills in English and French

230

Quality Specialist Resume Examples & Samples

Set up and maintain QC files for all US (Atlanta and Valencia) Flow Cytometry panels
Provide Technical Service support for Atlanta laboratory (QC, proficiency testing and Biannual instrument comparisons)
Locate and collate QC data for end of study Bio-Analytical Reports
Establish, review and amend global acceptance criteria for harmonized assay quality control material
Provide training to Global Harmonization team and regional laboratory teams, as needed
Minute and /or facilitate global technical meetings
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good command of the English language (both written and verbal)
Knowledge of clinical and/or research laboratory environment and safety and infection control procedures
Advanced Excel spreadsheet skills
Bachelor’s degree in Healthcare with at least one (1) year’ experience in a research laboratory/clinical laboratory environment required, or an equivalent combination of training, education and experience
Experience in Quality will be valued

231

Quality Specialist Resume Examples & Samples

Bachelor’s degree or higher required, preferably in a technical field
Green Belt Certification is preferred
Knowledge of statistical analysis is needed
Experience with thick film paste or Tedlar® films is preferred
Experience with ISO9000 standard and its application is preferred
A minimum of 2 years of experience in quality, R&D, technical service role or supply chain is required
Strong English communication skills is required
Great skills in dealing with customers and their concerns is highly desirable

232

Quality Specialist Resume Examples & Samples

This person will be responsible for the global execution of the Sales Enablement/Disablement process which includes the final quality review, product activation, or product deactivate in SAP
Review the completed Sales and Delivery Enablement Request forms by checking for completeness, Good Documentation Practices and accuracy and address any discrepancies according to corporate/regional policies and procedures, as well as ascertaining the impact to Hospira business
Upload completed quality records to SAP DMS system and assure compliance accuracy and completeness for the quality records and files
Must be able to work under minimal supervision and make decisions within scope of established procedures and guideline
Compile data and prepare metrics information for tracking sales and delivery enablement workflow
This person will be considered the Global SME for Sales Enablement / Disablement and will be responsible for the ownership of this process & will make improvements/adjustments as needed
Proficiency/expertise in SAP Document Management System (DMS) and SAP GUI required - must be able to manage the DCR and DIR lifecycle
Understanding of medical device lifecycle strongly preferred
Proficiency/expertise in Microsoft Office products including Word and Excel required - experience with creating pivot tables, graphs, charts, VLOOKUPs, and basic formulas highly preferred
Strong analytical approach to problem solving and solution development
Capabilities to get consensus, make decision, and assume them
Candidates should be very organized and have a flexible approach to operate in an international environment
Working experience in large corporate environment (manage contact with many cultures, time zones)
Ability to adapt communication according to the audience : from pure business to 100% technical
Capacity to anticipate issue resolutions and organize many different activities
Good relationships, ability to work inside a team, even disseminated around the world
Autonomous, ability to progress and deliver results independently
High School diploma; Bachelor’s degree from an accredited college or university is preferred (Engineering, Biomedical, Marketing)
3-5 years of experience in Medical Device organization preferred
Experience using SAP ERP (Inventory Control, Quality Module, Supply Chain)

233

Quality Specialist Resume Examples & Samples

Implements strategic quality direction into operational guidelines in the business unit
Develops quality work instructions and participates in quality manual documentation reviews/updates
Facilitates audits, recruits auditors from employee population, provides ongoing supervision
Trains coaches to Contact Handling procedures
May occasionally train CSRs
Reviews evaluates and effects continuous improvements to quality system training programs
Delivers and facilitates quality process training to organization
Reports and communicates to Director of Quality and/or Quality Manager, head of business unit and others on salient quality issues
Leads monthly Local Quality Council meetings and Management Reviews
Assists internal organizations in the monitoring, measurement and analysis of processes and system performance
Facilitates root cause analyses – business unit and corporate
Participates in Implementation Teams
Conducts documentation reviews of all local documents

234

Quality Specialist Resume Examples & Samples

Fundamental understanding of engineering principles
Experience of working in high volume production environment
Good understanding of machining and assembly processes and test procedures
Experienced in the use of problem resolution tools
Qualified to a minimum of HNC or equivalent in an engineering related subject
Minimum of four years apprenticeship & technical qualification eg ONC or equivalent

235

Quality Specialist Resume Examples & Samples

Reading and interpreting affidavits and other legal documents to understand their meaning and gain personal knowledge to the facts within and ensure they match the legal template
Verifying chain of title and holder of the note by review of the Note, Mortgage, Assignments, and Endorsements
Verifying financial figure accuracy against system of record, appropriately categorizing debts and amounts due and owing on the document as well as determining collectable and non collectable fees per local statutes
Thorough knowledge of the operational processes, procedures and systems
Solid / polished interpersonal and communication skills

236

Quality Specialist Resume Examples & Samples

Reviews quality results and identifies process gaps and helps determine solutions
Communicates regularly with department management and external sites to ensure consistency/quality of processes
Has frequent opportunities to make procedural choices for decisions related to process improvements; however, comprehensive process decisions are made by management
As required, may conduct quality review audits
May support an expansive and/or diverse array of products/services
Applies working knowledge of technical and professional principles and concepts and in depth knowledge of team objectives; and, impacts the business by ensuring the quality of the tasks or services provided
Understands how assigned duties contribute to the work of the team/unit and how the units coordinate their efforts and resources to achieve the objectives of the function
Thorough knowledge of the operational processes, procedures and systems. Strong problem solving skills
Experience in multiple operations functions

237

Quality Specialist Resume Examples & Samples

Maintain basic knowledge of manufacturing and warehousing processes and capabilities
The desire to learn and apply new concepts
Able to rely on experience and judgment to plan and accomplish goals
Must possess a strong customer service orientation and provide dedicated support of internal and external customer requirements
Must be a strong written and verbal communicator, able to communicate to various audiences effectively
Team oriented, must have the ability to work cohesively with others
Must be able to work well with external suppliers
Must possess ability to thrive in a manufacturing environment
Must be detail-oriented and self-motivated, able to work with minimal supervision
Must be able to work in a fast-paced, multi-tasked environment

238

Quality Specialist Resume Examples & Samples

Current California Registered Nurse (RN) license
Working knowledge of JCAHO standards and/or regulatory agency requirements regarding PI/Quality
Must be organized, detail oriented and like to work with statistics and evaluation of methodologies
Ability to deal effectively with all levels of hospital personnel, the public and physicians
Bachelor's degree in a health-related field
2+ years of experience with performance improvement or related area
Computer knowledge in Microsoft Word, Excel and Access programs

239

Quality Specialist Resume Examples & Samples

Performs 100% audit of process documents/log books to ensure completeness and accuracy for assigned E2E. Maintains any tracking databases and logs associated with this review. Reviews documents including batch records, log books, and critical site review packets. Coordinates with Production to discuss, resolve, and eliminate documentation defects
Performs batch release and prepares protocol documentation for agency submission and release
Performs Quality review/approval of new and updated SOPs and Controlled Job Aids. Ensures compliance with departmental procedures
Works with necessary groups within the E2E to resolve outstanding issues with process documents/log books and GMP walkthrough inspection observations
Reviews emergency stamps/hand stamps entered into batch records
Ensure proper identification of release status and control to materials through maintenance of batch and stock status in SAP and through physical tagging of material as required
Completes training to be a qualified auditor and completes monthly internal quality audits of the manufacturing areas in the E2E
At least 1.5 years experience in quality, operational, or technical function supporting manufacturing
Evidence of leadership skills coupled with good oral and written communication skills; i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
Attention to detail, flexibility and an awareness of production quality control
Basic understanding of cGMPs and or regulatory requirements as they apply to the pharmaceutical field or a related area
Must be able to work any shift with the possibility of a rotating schedule and/or including weekends
Aseptic gowning may be required

240

Quality Specialist Resume Examples & Samples

Prepares Product Quality Reviews for the EMEA region as per the relevant SOP. Primarily responsible for the preparation of oversight PQRs, this however, may be extended to other PQR types if necessary
Reviews, summarizes and generates a summary reports of product data
Liaises with both Mylan sites and External (3rd party) Manufacturers with the intent to gather relevant data
Produces a final report for review and approval, identifying any negative trends indicating concerns for product quality; initiates corrective actions upon management approval
Participates meetings related to the PQR process
Takes part in the creation, control and implementation of SOPs related to the function
Master/Bachelor Degree
Ability to work effectively with the Microsoft suite of Office applications and tools

241

Quality Specialist Resume Examples & Samples

Define quality- and test strategies for products respecting defined process- and product standards
Analyze, define, implement and execute quality and test related activities according to our quality- and test strategy
Create a detailed test design incl. test system landscape definition and product standards, prepare tests (for SaaS and PaaS), author and execute manual and/or automated tests
Be subject matter expert for our development teams in terms of quality assurance and test related processes, methods and tools
Initiate process or tool improvements
Provide transparency on quality status across development in teams
Strong working relationship within our Q-Team, with Product Owners and with Scrum masters
University degree – ideally in engineering / computer science
Expertise and experience in Quality Management and testing methodologies
Experience with agile development methodologies like Scrum and Kanban
Experience with the following tools: GitHub, Jira, Jenkins
A go-getter attitude, feeling of ownership
Ability to operate in a fluid, fast-paced environment
Strong communication skills in German and English and a superior team player is key
A self-starter to pick up and deliver on new tasks
5+ years expertise and experiences in Quality Management and testing methodologies including quality management for Cloud-based SaaS / PaaS
A plus is an excellent network into quality management for SAP’s product and development areas

242

Quality Specialist Resume Examples & Samples

Performing a variety of inspection functions to check quality and accuracy of in-process parts
Inspects and accepts and/or rejects purchased gauges or gaging equipment
Analyze special problems arising from faulty methods
Performs salvage weld operations on miscellaneous parts
Lays out parts using advanced mathematical calculations and precision inspection equipment
Minimum 1 year experience in a Quality based position
Ability to work various shifts and flexible hours

243

Quality Specialist Resume Examples & Samples

Expert level knowledge in iDocs
Working knowledge of CMS organization
Working knowledge of CB&I project work practices
Interfaces with Global Functional Managers (GFN) responsible for drafting and managing CMS procedures, guidelines, and work instructions
Interfaces with Project and Corporate Quality staff responsible for CMS monitoring and compliance
Strong electronic documentation skills
Fully proficient in Microsoft Office products

244

Quality Specialist Resume Examples & Samples

Serve as a leader for Quality Technicians I and II
Be responsible for audits/inspections/testing of fryer materials and products for conformance to specifications using fixed or preset measuring instruments to ensure quality, safety, and efficiency standards are met to customer satisfaction
Responsible for warranty data analysis, DOA reports, FPY reports and percentages, and Access Database development
Train new team members as needed

245

Quality Specialist Resume Examples & Samples

Performs and assists in coordinating resource allocation to conduct Stability Administration and Laboratory Administration activities to ensure accuracy and compliance against pre-defined standards and specifications
Performs document control functions to ensure the integrity of all Stability and QC Laboratory records in accordance with cGMP requirements
Interfaces with internal and external customers to maintain integrity of the Real Time Stability program and Laboratory Administration in conjunction with the Quality System
Communicates with internal and external customers to capture and assist in resolution of quality issues and projects
Tracks follow up activities associated with Real Time Stability and the QC Laboratory
Collects and analyzes Stability data that will be reported to management and other internal/and external groups
Reviews Stability records and QC Laboratory records prior to release to ensure that all documents meet regulatory requirements
Promotes good documentation practices to everyone who records information relevant to Stability and QC Laboratory records
Ensures that all OOS and non-conforming material related to Real Time Stability has been properly identified and that an OOS investigation is initiated
Communicates any unexplained discrepancies or deviations to Supervisor to ensure proper investigation is conducted and documented
Analyzes and interprets laboratory documentation for non-conformities
Participates on Laboratory Improvement projects
Performs records management and record retention activities
Generates reports and metrics
Responds to escalation of issues from the QC Laboratory team
Responsible for ensuring a safe work place while producing a quality product
High School Diploma and 5 years-experience working in an administrative role in a cGMP manufacturing environment,
OraBachelors and 1 year of administrative experience supporting a cGMP manufacturing environment
Advanced math and computer skills – Microsoft Office
Problem solving skills, including root cause analysis
Knowledge of basic statistics and sampling plans
Must be able to follow verbal and written instructions
SAP, Microsoft Excel, Word, Access, Agile and SharePoint experience, preferred
Ability to work in a dynamic environment and self-motivated

246

Quality Specialist Resume Examples & Samples

Conduct compliance audits of less complex documentation and data and approve use of Design History Records, Device Master Records, Nonconformances, Document Changes, Validations and Change Controls
Demonstrate working knowledge of Quality Control, Manufacturing and Inventory processes
Serve as QA interface with limited responsibilities to other departments
Prepare data packages for external customers (Business or Marketing partners) and regulation bodies
Perform compliance activities such as Product Holds, room releases, etc
Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements
Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners
Assists in developing quality systems & make recommendations for improvements to existing Quality systems
Perform special assignments as designated by the supervisor/manager
Performs other relevant duties as assigned
Basic understanding of QSR & ISO requirements
Basic knowledge of QC, Manufacturing & Inventory processes
Must demonstrate initiative, balanced assertiveness, flexibility and team orientation
Working knowledge of Microsoft Word, Excel, Power Point and related functions including the formulation of graphs
2-5 years related quality experience

247

Quality Specialist Resume Examples & Samples

Maintain a positive, professional working relationship with all customers and be responsible for meeting customer quality expectations
Perform audits on service parts and kits, using measuring tools prior to final sales to ensure zero (0) defects
Exhibit the ability to understand quality contractual requirements related to the assigned product types
All product quality deficiency reports must be completed on time (includes CIR, PQDR, CAR, TIR, etc.)
Actively participate at all quality meetings including control testing and corrective action board Communicate effectively with suppliers and internal teams to correct and prevent deficiencies on service parts and kits prior to final sales
Analyze and implement effective solutions to quality related problems
Assist Quality Technicians on disposition of defective material
Analyze and make disposition of rejected materials
Coordinate and execute quality audits internally and externally
Assist in establishing and maintaining quality guidelines and procedures
Responsible for product supplier quality and process control
Report and respond to quality process nonconformance issues in an expedient manner Implement effective corrective and preventative actions utilizing structured planning methods Coordinate and work inter-functionally with Quality, Engineering, Contracts, Sales, and Manufacturing to resolve quality related issues
Responsible for writing/updating Standard Operating Procedures for quality processes
Travel as required (very minimal if any)
Accurately maintain company records and documents in accordance with policies and procedures
One plus years of related work experience
Advanced training/experience in the use of statistical techniques and process improvement methods
Experience with the Production Part Approval Process (PPAP)
Experience with reading blue prints
Experience with writing Standard Operating Procedures (SOP)
Experience with the use of structured problem solving techniques utilizing computer applications
MS Windows, Microsoft Word, Microsoft Excel, Microsoft Project, Lotus Notes E-mail, and JDE experience is recommended and will be mandatory within three months in this position
Previous experience in a high volume warehouse is a plus

248

Quality Specialist Resume Examples & Samples

1) Maintain quality control documentation and specifications for contract manufacturers
2) Control and conduct internal audits to ensure compliance
3) Track and maintain deviation, risk estimate/assessment, change control request processing
4) Technical writing of SOPs and other quality control documentation
5) Excellent computer skills (MS Office)

249

Quality Specialist Resume Examples & Samples

Interact with the Manufacturing floor staff regularly to answer questions related to GMPs and champion a compliant work environment
Work with the Manufacturing Technical and Compliance Support team to evaluate and implement global CAPAs, regulatory/audit commitments, and general improvement projects
Investigation ownership of Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise
4+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency at validation and/or change control (with BA or BS in biological science or engineering)
2+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency at validation and/or change control (with MS in biological science or engineering)

250

Quality Specialist Resume Examples & Samples

Plan and oversee the development of operational plans or procedures and coordinate with customer and supplier representatives to ensure satisfactory quality system performance
Resolve issues at department or company level
Analyze and compile performance reports and process improvement statistics in order to determine and improve process capability; develop statistical process improvement procedures
Develop data for Corrective Action Review across the organization. (additions)
Act as liaison between quality, engineering, tooling and other support functions
Subject matter expert for metric driven data for quality and material review board engineering
Develop, collect, and analyze data and information from a variety of sources
Perform such specialized quality functions as data preparation, analyses and reporting; development of quality tools, techniques and methods; process improvements; maintenance documents and records; preventive and corrective actions; customer interface, liaison and support
Develop, deploy, monitor, and analyze the results of statistical data and process control methodologies
Coordinate the development and deployment of operational and corrective action plans, procedures, and milestone schedules in response to data and analysis
Perform investigation as required of customer complaints and escapes including root cause and corrective action facilitation
Provide metrics, data and reports to various internal and external customers as required to meet demands of the business
Perform and lead such specialized quality functions as data preparation, analyzes and reporting; development of quality tools, techniques and methods
Provide technical expertise to company employees, suppliers, customers and regulatory agencies to ensure compliance with contractual, company, and regulatory requirements
Provide education and coaching on the company’s quality system
Pursue personal development of skills and knowledge necessary for the effective performance
Associates Degree in Business, Engineering or other technical field; combination of education and relevant experience in lieu of degree may be considered
3+ years’ experience in quality or compliance
Familiarity with AS9100 and government contracting
U.S. Person
IT background preferred
Experience in the aerospace industry
Good written, oral communication skills
Able to develop daily report, develop metrics, design and implement dashboards that allow for ease of access to metrics
Good knowledge in PL/SQL statements, HTML, CSS, VBA and JavaScript
Computer literate in statistical software, Excel, Word, Access and PowerPoint

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Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

Quality Specialist Resume Examples & Samples

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