QA Specialist Resume Samples

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R Kozey

Rodolfo

Kozey

5682 Carter Underpass

Dallas

+1 (555) 339 2601

5682 Carter Underpass

Dallas

Phone

p +1 (555) 339 2601

Experience Experience

Philadelphia, PA

QA Specialist

Philadelphia, PA

Nienow-Carroll

Philadelphia, PA

QA Specialist

Assist in the development of robust quality improvement coaching and training processes to drive continuous improvement
Applies technical and/o9r managerial expertise to improve effectiveness and provide guidance to employees in own area
Provide feedback to assist in the creation of performance improvement goals and training programs
Provides input in development and implementations of performance improvement initiatives
Perform call and email monitoring and provides trend data to site management team, Sr. Manager and Supervisors
Establish effective working relationships to help identity issues, provide solutions and establish priorities
Provide the NA operation with a holistic view of customer performance and identify the levers which will drive improvements

Phoenix, AZ

Software QA Specialist

Phoenix, AZ

Rohan and Sons

Phoenix, AZ

Software QA Specialist

Develop, manage and write test plans that provide comprehensive test coverage for small to large and complex projects
Provide assistance with system development life cycle (SDLC) activities, write SOPs for SDLC procedures
Gather training feedback for training and development improvements going forward
Work with project managers and project stakeholders to coordinate quality expectations, and plans for the project
Create testing reports to communicate results to management
Working knowledge of load generation/load balances/Controllers/performance measurement software
Maintain awareness of industry trends and technology in order to advise management of recommended improvements to the quality assurance process

present

Dallas, TX

Senior QA Specialist

Dallas, TX

Farrell-Schmitt

present

Dallas, TX

Senior QA Specialist

present

Work closely with developers and customers and enforce quality at all level of software development
Providing Quality Assurance (QA) support to Manufacturing, Quality Control, Analytical Development and Process Development
Set personal performance goals and collaborate with management to establish organizational objectives
May provide guidance and manage work activities of other staff members for specific projects or objectives
Work directly with other key Company departments to ensure compliance and productive working relationships
Develop and train personnel and internal customers on risk management business processes
Develop and aid in development of solutions for moderate to complex problems

Education Education

Bachelor’s Degree in Science

Liberty University

Bachelor’s Degree in Science

Skills Skills

An accountable leader who is detail and quality oriented with a solid understanding of quality principles, methods, and procedures
Good working knowledge of Quality Systems and cGMP standards applicable to clinical development
An accountable team player who is detail and quality oriented with an in-depth understanding of quality assurance principles, systems and procedures
An accountable team player who is detail and quality oriented with an understanding of quality assurance principles, systems, and procedures
Strong organizational skills and strong attention to detail, yet can be flexible and able to incorporate changes efficiently in a short amount of time
An accountable team player who is detail and quality oriented with advanced understanding of quality assurance principles, systems, and procedures
Most have strong authorship and be able to critically review reports while effectively inputting and expressing Quality risk management principles
Working knowledge of SDLC methodology and ability to audit systems against the methodology and applicable regulations
Excellent attitude with good verbal, interpersonal communication, excellent judgment and multitasking skills who can adapt to changing priorities
Excellent verbal and written communication skills in English (professional proficiency)

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QA Specialist Resume Examples & Samples

Provide quality assurance (QA) on all campaign launch/modifications across the NBC News Portfolio and providing critical troubleshooting on major campaign launches
Responsible for refining and managing NBCU’s QA process to ensure the delivery of high-quality, error-free deliverables. This includes recording metrics across the team, tracking missing creatives for Sales, Inventory and Operations, as well as maintaining a fluid schedule of roadblocks across the network
Work directly with the Sr. Director, Digital Sales Operations and management team to ensure that all details of sales operations are being upheld and that the Sales team is being properly supported
Familiarity with ad-serving systems (FreeWheel, DFP-P, Mocean, etc.)
At least two years experience in an ad operations or trafficking role
Familiarity with emerging video and mobile product landscape

QA Specialist Resume Examples & Samples

Minimum of 5 years of Front-end GUI and Middleware application performance testing
HP Performance Center and Web Services protocol knowledge required
Min 5 year experience with the following tools sets: HP Loadrunner, HP Performance Center, HP Quality Center, Willy Introscope, Sitescope
Scripting, Executing and Analyze performance test and solutions though business, functional and technical expertise
Proven ability to meet tight deadlines
Knowledge of C , VB, and /or Java
Strong written communication and status skills
Strong skills with performance test requirements gathering and reviews, creation of Performance Test Plans and Final Results and Analysis documents and presentation to business partners

Functional Testing QA Specialist Hpqc Brokerage & Wealth Management Resume Examples & Samples

Acts as a focal point for the functional testing teams and oversees the planning and execution
Provides guidance and direction to project team as appropriate
Liaise with senior management with regards to the functional testing process for individual projects and programs
Opportunities for growth and career advancement

Lead Functional Testing QA Specialist Resume Examples & Samples

Liaise with senior management with regards to the functional testing process & strategy for individual projects and programs
Manages all aspects of functional testing including: test strategy and test planning (including distribution of work, promotion of packages, distribution of regression packages, and sign-off) in order to ensure an effective and efficient testing approach
Possesses expert analytical skills for complex problem solving
Exhibits expert communication skills, both written and verbal
Solid understanding, knowledge and experience brokerage and investment business is required
Must have hands on experience working with testing tools HPQC and QTP
Leading testing strategy and planning

Senior Development QA Specialist Resume Examples & Samples

Managing a small QA team for day to day activities
Organize planned or systematic actions to provide enough confidence that an application or a service will satisfy the given requirements for quality
Perform activities of providing evidence needed to establish quality in applications before deployed to production
Participate in business requirement gathering meetings to understand business requirement in order to develop test plan, compile application system test cases and user test cases during an application is being developed
Acting as a lead to liaise with internal business users, external clients and/or other counterparties, business analysts, project managers and application developers to conduct user acceptance test and/or production parallel test
Work with business users to resolve data related issues during UAT and/or PPT
Conduct best software test practices and apply them into SS&C Fund Services’ test environments
Excellent written and verbal communication skills and good interpersonal skills
Excellent ability to organize multi-party involved application testing activities
Familiar with various investment products is desirable but not required
Demonstrate effective bug and defect tracking and reporting mechanism. Familiar with TFS defect tracking is highly desirable
Software development experience is desirable not required. Good understanding of software development lifecycle is required
Understanding SQL server and basic SQL coding
Proven analytical and problem-solving skills
Accept responsibility and Personal accountability
Highly logical, proactive, and keen attention to detail
Ability to work well independently or as a member of a team
Demonstrate flexibility, reliability and adaptability in approach to work
Demonstrate effective teamwork and working relationships with internal and external customers
Demonstrate a self-directed approach to learning new technologies in the field; pursue professional development
Take personal ownership (going beyond assigned tasks to make project better, identifies and reports issues, demonstrates strong concern for client and Initiatives)
Demonstrate personal leadership

QA Specialist, Digital Ad Operations Resume Examples & Samples

Provide quality assurance (QA) on all campaign launch/modifications across the portfolio and providing critical troubleshooting on major campaign launches
Assist in identifying areas of weakness across the operations team and help in preparing and training the Ad Operations Coordinators on changes to process and reoccurring issues
Work directly with the Director of Sales Operations to ensure that all details of sales operations are being upheld and that the Sales team is being properly supported
On call support is required for after hours ad-related emergencies
Familiarity with ad-serving systems (FreeWheel, DoubleClick DART, Atlas, etc.)
Expert on trouble shooting ad related issues
Ability to set and self manage goals, deadlines and multiple assignments concurrently in a project based environment
Familiarity with emerging video product landscape
Ability to train and present to Ops and Sales organization

QA Specialist Showtime Anytime Resume Examples & Samples

Perform tests of new features and functionality of Showtime Anytime
Display ability to prioritize and resolve issues interfering with the Customer Experience
Working knowledge of Smart TV apps
Experience with MongoDB a plus

Card Operations QA Specialist Resume Examples & Samples

Communicates professionally and effectively with management and other departments
Conducts daily reviews and prepares monthly reports to ensure regulatory compliance while effectively providing quality service
Assists in developing and documenting new procedures
Cross-trains to support new and existing functions/initiatives
Implements and performs various functions or projects as assigned
Good knowledge of Bank of the West applications

Senior QA Specialist / Responsible Person Resume Examples & Samples

Meets qualifications to be a Responsible Person (RP) in Ireland
Significant experience working in the biopharmaceutical industry
Must be able to prioritize and multitask in a challenging environment
Must be able to read, understand, speak and write technically and legibly in English
Meets qualifications to be a Qualified Person (QP) in Ireland
Experience working with multiple sites/locations
Experience with Aseptic/Sterile processing
Experience working with contract manufacturing organisations

QA Specialist Resume Examples & Samples

Had medical related education or college degree preferably in Business Administration
A minimum of 5 years administrative experience in English environment
Fluent English is preferred

QA Specialist Resume Examples & Samples

Bachelor's degree in Science/Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry
Bachelors preferred and 3+ years' experience in Quality Assurance and/or in a GMP regulated environment with the pharmaceutical industry or equivalent
Sterile product manufacturing knowledge preferred
Biopharmaceutical experience a plus and experience with SAP

QA Specialist Resume Examples & Samples

Influence and facilitate the work of other departments and functions in achieving and maintaining state of GMP compliance
Establish effective partnerships with other individuals, departments and GBSC affiliates so that compliance activities are well understood and coordinated
Actively promote improvement programmes towards continuous compliance during qualification and validation
Actively promote and apply strategic thinking to compliance activities
Facilitates the work of other departments and functions in achieving and maintaining state of GMP compliance during qualification and validation activities
Establishes effective partnerships with other individuals and departments so that quality systems and compliance activities are well understood and executed to a high standard. *Interface with all site departments, Operations and Maintenance
Contact with Quality Assurance Manager for management of qualification and compliance activity
Directors and managers of other departments for coordination of qualification document reviews and approvals, including associated change controls, non-conformance investigation, and completion of commitments
Bachelors Degree in a scientific/technical discipline required
A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry
Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Desirable
Experience in statistical sampling plan development
Experience in a biopharmaceutical or pharmaceutical plant startup

Software Engineer QA Specialist Resume Examples & Samples

Minimum 7 - 10 years experience
Excellent written and verbal communication skills; mastery in English and local language. Ability to effectively communicate product architectures, design proposals and negotiate options at management levels
Strong Background in Test Processes and Concepts
Expertise in testing enterprise products
Expertise in Unix/Linux Kernel environments
Test Plan creation, Test Execution and Test automation
C Programming and Shell Scripting
Basic Understanding of File System and Volume Manager
Understanding of File System Internals
Automation Framework Development
Debugging Skills such as Crash Dump Analysis
Storage Concepts Understanding / Expertise (RAID, SAN, NAS, etc.)

Software Engineering QA-specialist Resume Examples & Samples

5+ years of testing experience in high-performance database-centric Enterprise-class software, performing black box and white box testing
Solid understanding of security, network storage systems, networking, load balancing, clustering, enterprise security integration including experience with multi servers configurations
Hands on with hardware and comfortable to work in the lab environment, previous IT background helps
Experience with setting up LDAP, RADIUS, AD, any load balancer. A good knowledge of TCP/IP, HTTP
Experience with SQL,mysql, databases such as PostgreSQL and Oracle
Knowledge of internalization, globalization, localization, i18n, byte character support
Oracle installation and configuration on Oracle admin level
Experience to test Java GUI based applications
Solid experience on Unix: Linux, Solaris, AIX and Windows NT operating systems
Good understanding of OOD concepts and Java concepts
Must be proficient and comfortable at problem diagnosis, troubleshooting and problem solving
Possess the ability to be a self driven quick learner with attention to details and quality
Be proficient in risk management and prioritizing tasks for short cycle release with floating release scope
High level English (speaking, reading & writing) - Must

QA Specialist Resume Examples & Samples

Perform all activities in compliance with safety standards and SOPs
Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely
Write, review and approve Standard Operating Procedures in accordance with Policies
Participates in customer complaint investigations
Provide overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and internal expectations
Act as Quality point of contact and decision maker during Technology Transfer and Process Validation activities whilst ensuring that all activities meet internal and regulatory expectations
Site Program Owners for site disposition activities, Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability and Product Quality Review
Co-ordinates and approves the preparation of reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes
Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role
Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections
Experience working in aseptic operations, protein formulation, vial and syringe filling

Healthcare QA Specialist Resume Examples & Samples

Demonstrate an ability to learn and understand the processes for all of the functional areas in order to perform quality reviews across all functional areas
Meet performance standards for Quality, maintaining a quality score of 97% or higher
Conduct objective concise quality assessments
Meet the productivity standards for each of the functional areas
Maintain a strong understanding of all functional areas and serve as a source of expert knowledge of the program and functional areas
Update the quality monitoring data management system to compile and track assessment information
Assist to implement and maintain quality processes, practices and measures for front line assurance activities and an increasing awareness for quality controls
Perform administration tasks as needed by the business and to support key objectives of the Quality Team
Contribute toward improvement of current processes
Track and ensure staff return quality assessments requiring corrections
All other duties as assigned. Experience/Education: College degree preferred. Experience in government services to consumers, particularly health and human services or an equivalent combination of education and experience preferred. Experience in public sector healthcare, Medicaid and/or CHIP a plus
Strong verbal and written communications skills,strong interpersonal skills, and ability to work in a team environment. Ability to communicate effectively through clear, concise written documentation, verbal presentations and interviews
Strong analytical, organizational, time management and problem solving skills
Ability to produce accurate results
Display motivation, initiative and ability to handle multiple projects
Ability to handle the stress of fast-paced, rapidly changing processes and guidelines
Working knowledge of functional areas/processes and a willingness to gain an understanding of other operational processes
Ability to work independently and demonstrate a high level of confidentiality regarding Quality assessments
Ability to use MS Word, MS Excel and MS Outlook required
Ability to achieve results through knowledge, empathy and commitment
Bi-lingual preferred
Ability to type 40 WPM Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel objects, tools, machines, or controls; and reach with hand and arms. The employee is occasionally required to stand; walk; stoop, kneel, crouch, or crawl; and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Work is generally performed in an office setting. The noise environment is usually quiet
Overtime, days, evenings and some weekend hours. Fast pace

Senior QA Specialist Resume Examples & Samples

Support the global development and implementation of corporate policies, SOP’s and working practice documents to facilitate continuous improvement of performance and compliance
Review and approve qualification and validation documentation in a timely manner ensuring compliance with GMP. Assure that all calculations and data are correct and any observations/non-conformances are properly investigated and explained
Communicate with other departments within Shire on quality and compliance issues. Effectively communicate possible cGMP deficiencies and validation concerns appropriate departments
Support / complete as required Periodic Reviews, self inspections and or Supplier audits
Evaluate change control documentation for compliance/validation/GXP impact and determine validation requirements for that change
Stay current with changes to the relevant industry legislation and guidance documents so that Shire’s IT compliance policies / Quality Manual sections are current
Participate in IT project meetings and give input on QA issues related to CSV
As required, assist in regulatory inspections regarding IT validation activity
Participate if necessary and provide input in internal cGMP audits
Initiate new policies SOPs and WPDs or revise existing policies SOPs and WPDs as appropriate for IT QA as needed
Provide backup for other IT QA personnel
University degree or equivalent qualification, preferably in a life sciences subject
Experience of working with Quality Systems and Information systems
Appreciation of Pharmaceutical dosage forms and relevant Global GMP legislation and guidance
Knowledge of GAMP and computer software validation experience is preferable
Articulate, computer literate, good analytical skills, problem solving ability, decisive, good interpersonal and influencing skills

Healthcare QA Specialist Resume Examples & Samples

Strong verbal and written communications skills, strong interpersonal skills, and ability to work in a team environment. Ability to communicate effectively through clear, concise written documentation, verbal presentations and interviews
Ability to type 40 WPM
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel objects, tools, machines, or controls; and reach with hand and arms. The employee is occasionally required to stand; walk; stoop, kneel, crouch, or crawl; and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus

QA Specialist Operations Resume Examples & Samples

Provides QA support for the manufacturing of commercial unpurified bulk product and drug substance to ensure compliance with the principles and guidelines of current Good Manufacturing Practices
Actively partners with manufacturing operations and auxiliary support groups to provide compliance and technical guidance to ensure that product quality issues are identified and resolved in a timely manner through the appropriate quality system
Second shift position, working a Wednesday through Saturday schedule
Job title and level will be commensurate with relevant experience

QA Specialist, Games Solutions Group Resume Examples & Samples

Test configuration and compatibility of software on multiple platforms, including mobile devices
Attention to detail, excellent communication skills
Has shipped one or more games

Senior QA Specialist Resume Examples & Samples

Network with key contacts outside own area of expertise
Providing support during regulatory agency site inspections
A minimum of a B.S. degree in science or engineering with at least 5-10 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments
Bold: Act with integrity in all you do. Be forth right in a way that builds sustained relationships. Demonstrate respect for the individual, diversity and the environment
Resilient: Believe in your convictions; anything is possible! Take measured risks and create innovative solutions that make a difference
Accountable: With relentless dedication, serve our patients in everything you do. Create a quality customer experience for those you interact with
Visionary: Demonstrate a true sense of urgency and don't make great ideas wait. Make progress everyday to avoid the complacency that prior success may bring
Ethical: Trust your colleagues and draw on their input for better outcomes. Collaborate across boundaries and geographies. Build openness through teamwork and focus on tackling business challenges

QA Specialist Resume Examples & Samples

Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met
Partners with other Departments to ensure that compliance systems are implemented in an efficient manner
Supports the management of GMP compliance systems through the following activities: Assesses compliance systems on ongoing basis to identify opportunities for process improvement
Carries out tasks related to the administration of project and site non-conformance management systems
Reviews and/or approves non-conformance investigations and their associated documentation
Manages entry of non-conformance records into the appropriate electronic system
Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate
Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate
Approves closure of non-conformance investigations on completion of the investigation and associated corrective actions
Carries out tasks related to the management of project and site change control systems: Reviews and/or approves change control requests, implementation actions, and request closures
Manages entry of change control records into the appropriate electronic system
Tracks records from the initiation through closure processes

QA Specialist Resume Examples & Samples

Write test cases and use tracking tools to file, monitor and resolve issues
4+ years directly testing and/or supporting web and mobile media applications
4+ years using any defect tracking tool. (Jira a plus)
Strong documentation and communication skills

Software QA Specialist Resume Examples & Samples

Provide technical leadership for solutions in non-functional requirements collection and its analysis, performance engineering, scalability analysis, performance testing, bottleneck analysis, performance tuning and reporting
Work closely with Project Architects to make sure that the Non - functional - requirements are properly addressed and traced in the solution architecture
Provide technical leadership and direction to testing team members to adherence to coding, quality, functionality, performance, scalability and on-time delivery standards
Define, improve and automate metrics collection and reporting
Drive test effectiveness and efficiencies throughout the team
Drive research of industry trends and apply best practices in quality engineering practices
Provide consulting services on techniques to achieve of quality goals through education, training, coaching and collaboration
Bachelors in Computer Science/ Engineering; Masters is desirable
9+ years of software engineering experience in product organization distributed across globe
Expertise with testing methodologies, tools, automation and approaches including stress, load and performance testing
Demonstrated experience designing scalable and maintainable automated testing solutions for large scale systems
Working knowledge of load generation/load balances/Controllers/performance measurement software
Strong understanding web technologies and hands on programming skills
Expertise in working with web applications in an agile environment

QA Specialist Resume Examples & Samples

Executing European quality systems and maintaining and improving quality metrics
Writing & leading deviations, change controls, CAPA, investigations and nonconformance reviews, etc
Drafting & coordinating TQAs
Drafting specifications
Designing and implementing EU Quality Systems and maintaining and improving quality metrices
Drafting drug product complaint reports and support any recall efforts in conjunction with QP
Supporting the external auditing program
Supporting returns & destructions
Conducting training, including GMP/ GDP, for European staff
Support Product Quality Review
Participating in technology transfer, process scale-up, and process improvement projects
Assisting in meetings with external parties and representing Shire in a professional manner
3-5 years experience working in Quality Assurance supporting the manufacturing of drugs, biologics, or devices
Must be able to prioritize and multitask in a stressful environment
Experience conducting audits as lead auditor
Interpersonal skills and professional skills to interact with contractors while representing Shire
Knowledge of QP function and Manufacturing/ Wholesaler Licenses
Evaluation of deviations/investigations to ensure there is no impact to safety, identity, strength, quality, or purity
Evaluation of changes to regulatory filings and/or validated systems

Senior QA Specialist Resume Examples & Samples

MS with 7+ years or BS with 10+ years and at least 8 years of relevant experience
Strong Quality Control knowledge, previous experience in QC Raw Materials required
Previous experience with Supplier Audit and Oversight is a plus
Must be flexible. Must be able to prioritize and multitask in a dynamic environment
Fluency in English is required

Senior QA Specialist Resume Examples & Samples

Participate in site activities associated with QMS programs (e.g., Validation, Complaints, change Control) and provide active input into shaping the future direction of these systems
Provides training and advice to staff in order for them to perform their desired functions
Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc
Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
University degree. Engineering or Science related discipline preferred
Experience working with dynamic cross-functional teams and proven abilities in decision making
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations

QA Specialist Resume Examples & Samples

Research or investigation of reported issues
Ensures test results and metrics are collected and reported
Functional, Regression, System-Level Integration, End-to-End and Acceptance Testing
3+ years of experience in quality assurance/software development
Experience in writing SQL Queries
Ability to work effectively and confidently with users, team members, and management
Must be flexible and willing to undertake a wide variety of tasks
Strong facilitation, organizational, and critical thinking skills
Web services experience is a plus

Principal QA Specialist Resume Examples & Samples

Provides to the site and network, expertise in Operational Quality (includes expertise in a number of the following topics: Deviation/NOE/LIR coaching, Change Control coaching, Environmental Monitoring programme, Sterility Assurance, Customer Complaint investigations, etc)
Uses knowledge to improve Operational Quality, solve complex problems, provide continuous improvement and execute tasks
Acts as a resource to colleagues with less experience in Operational Quality
Leads project teams
Coaches and guides colleagues within the site and also in the network
Interprets customer needs, assesses requirements and identifies solutions to non-standard requests
Makes decisions within guidelines and policies which impact Product Quality
Liaises with Corporate Quality to ensure alignment on actions related to Operational Quality at the site
Works with other sites to ensure alignment and best practices adopted on site for Operational Quality
Degree (in Science)
At least 5 years' experience in the Pharmaceutical industry or a similar operating environment which includes a minimum of 2 years' experience in a Quality function
Quality Assurance SME knowledge from both operation or educational experience, is required
Demonstrated expertise in Quality Management Systems
Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance
Demonstrated ability to drive the completion of tasks
Proven track record of providing independent Quality expertise to the site
Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, etc
Advanced PC skills such as Excel, Word, and PowerPoint

QA Specialist Resume Examples & Samples

Developing and maintaining a strong knowledge of all Blackboard products and standards
Performing all types of testing as needed including regression, functional, boundary, error, compatibility, scenario and exploratory testing
Writing supportive documentation for completed testing tasks
Working with the QA project lead to create testing tasks and detailed test cases for user stories
Creating and managing regression test cases and other supporting technical documentation
Writing clear and effective defect reports and explaining defects to other testers and developers
Working with all project tools used by our department such as Target Process
Participating in defect resolution and retesting as appropriate
Utilize Selenium and C# to create and run automation scripts, reviewing and recording results
Assisting the QA manager with technical support & training of internal clients as required
Bachelor’s degree (B.A.) from a four year college or university; or one to two years related technical experience and/or training; or equivalent combination of education and experience
At least 1 year of experience in software testing utilizing automated testing tools (Selenium, Ranorex, Loadrunner)
1 year of experience writing test automation scripts (Java, C#, Ruby)
Knowledge of software testing methodologies, tools and approaches
Able to write reports in Microsoft Excel and Word or similar products
Able to troubleshoot and explain technical issues to technical and non technical users
Knowledge of common web browsers
Knowledge of Windows and Apple operating systems
Able to work in an agile short release cycle environment
Able to test independently and work within a small development teams
Able to prioritize tasks and manage workload to complete projects in required time frame
Professional appearance and mannerisms to represent Blackboard accordingly
Ability to maintain flexibility as roles evolve
Knowledge of modern business communication standards, styles, and formats

QA Specialist Resume Examples & Samples

Manage the activities of a defined team of QA professionals
Ensure full compliance with GMP
Carrying out and documenting risk assessments
Reviewing packaging record for in process and finished products
Review equipment qualification and process validation documentation
Degree in Quality or similar is required
Extensive experience working in a GMP environment
A minimum of 3 years' experience in a QA role within the pharma industry
Strong ability with work FDA / EMEA standards and quality systems
Strong ability and willingness to hit the ground running, along with working in a team orientated business

Consumer Direct Sales QA Specialist Resume Examples & Samples

Completes assigned quality assurance monitors for Mortgage Bankers following guidelines
Review results to determine if additional training is needed on areas where scores are consistently below expectations
Maintains knowledge of current Contact Centers' operating procedures and products and services offered. Acts as a subject matter expert in regards to policies, procedures and services offered
Conducts professional verbal and written communication with all customers, staff, co-workers and management team members. Maintains professional behavior and positive working relationships both internally and when representing Bank of the West in the community
Understands and adheres to all training and bank policies, laws and regulations applicable to role. Completes all compliance training, follows internal processes and controls as required. Reports all compliance issues, violations of laws or regulations in accordance with the steps as defined by Bank of the West
High School Diploma or GED required
Thorough knowledge of mortgage finance
Thorough knowledge of Bank policies, standards and guidelines
Thorough knowledge of federal regulations and regulatory agencies such as USPAP, FIRREA, HMDA, RESPA, FNMA, FHLMC, VA, FHA, RD and Fair Lending

BSG QA Specialist Resume Examples & Samples

Keeps supervisor/manager informed of any and all situations
3 years in branch operations and/or back-office experience
Demonstrates ability to prioritize assignments and work independently or as a contributing team member
Good knowledge of bank operations and procedures

QA Specialist Level Resume Examples & Samples

Support deviation and atypical event close out and initiating/following up on corrective and preventative actions
Support the development and implementation of improved quality reporting measures
Support the New Material Introduction Process
Quality Agreements with Suppliers
Promote continuous improvement of the Quality Management System
Provide direct support during regulatory audits
Conduct self inspections as appropriate
Provide training in all aspects of Quality Management Systems and GMP
4+ years experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry
Knowledge of EU/US quality related pharmaceutical regulations
Experience of conducting quality based investigations and root cause analysis
Degree in Science or related discipline

Senior QA Specialist Resume Examples & Samples

Bachelor's degree and at least 3 years of Quality Assurance experience
A strong working knowledge of GCP, ICH and QA Principles
Experience within a Pharmaceutical, Biotech or Research Company
A working knowledge of SDLC methodology, computer system validation and 21 CFR Part 11 including auditing against these regulations
A valid driver's license and the willingness to travel up to 10% when needed

Senior QA Specialist Resume Examples & Samples

Ability to create, manage and improve complex Quality systems, integrating with existing systems
Good interpersonal skills required
Adherence to domestic and international GMP regulations, cGMP’s, company policies and DNA leadership capabilities
Strong prioritization and delegation skills
Understands the needs of key collaborators and customers, and interacts effectively intra- and interdepartmentally to achieve alignment and consensus
Must be capable of defining, implementing, and successfully defending sound QA systems’ approaches and principles
Seeks the input of others before making a decision. Demonstrates personal dedication; balances personal needs with Shire’s needs. Illustrates dedication to Shire by going above and beyond expected individual responsibilities

Senior QA Specialist Resume Examples & Samples

Ability to independently review and question technical and complex issues involving a multitude of Functional Areas
Capable of defining, implementing, and successfully defending sound QA systems’ approaches and principles
Self-motivated and driven to independently accomplish department goals and objectives; Teamwork skills essential; Strong organizational skills; Positive outlook and motivating
High degree of organizational intelligence with the ability to identify key Functional Areas that contribute to the overall technical operations at Shire
Demonstrate unwavering ethics and respect for all customers. Practice open and honest communication, building authentic relations. The individual must be flexible to effectively embrace change. When faced with challenging circumstances, finds creative ways to ensure achievement of the desired
Building authentic relationships
Global & Cross Boundary Communication
Energy and Drive

QA Specialist Resume Examples & Samples

Must be able to work occasional weekends
Proficiency with Microsoft applications Word, Excel, Project, and Powerpoint; ability to learn additional software applications, as the need arises
Ability to work effectively in a fast-paced environment
Teamwork skills essential

Senior QA Specialist, QA External Biologics Resume Examples & Samples

100%
Bachelor’s degree in chemistry, biology or a related discipline
8 years Quality Assurance experience supporting the manufacture and release of commercial drugs, biologics or devices manufactured at CMOs
Working knowledge or batch record review
Working knowledge of human blood and blood products requirements
Experience with authoring Drug Product Annual Product Quality Reports
Good understanding of quality systems and cGMPs
TrackWise, LIMS and SAP experience
Must be flexible
Critical thinking/ evaluation of process problems
Data trending and evaluation
Ability to multi-task in environment with changing priorities
Strong work ethic

QA Specialist, Showtime Anytime Resume Examples & Samples

4+ years directlytesting and/or supporting web and mobile media applications
4+ years using anydefect tracking tool (Jira a plus)
Experience testing appsfor devices such as Roku, Amazon Fire TV, Apple TV, Xbox, and Playstation
Working knowledge ofSmart TV apps
Experience testingbrowser compatibility across both Mac and PC platforms
Experience writing testplans and test cases
Strong documentation andcommunication skills

Senior QA Specialist Resume Examples & Samples

Supporting on-the-floor manufacturing operations
Responsible for the review and approval of batch production records and associated supporting documentation
Perform equipment use log audits, communicating observations and driving audit closures
Providing general off-the-floor QA consultation to manufacturing and support departments
Supporting miscellaneous QA tasks
Management of a limited number of deviation reviews
Perform manufacturing document issuance as needed
A minimum of a B.S. degree in science or engineering with at least 5-7 years of relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments
Experience supporting manufacturing operations is preferred

Senior QA Specialist Resume Examples & Samples

Identify software defects, report and manage their lifecycle to ensure quality assurance. Submit and update records in the issue tracking system (JIRA) based on testing of the system and support of the implementation of corrected and/or new code
5 years of hands-on experience as a Senior Software Quality Assurance Engineer with strong background in software development methodology management and quality assurance skills
Ability to clearly and persuasively communicate complex issues and make oral presentations
5 years of experience in performing regression testing for websites including the development and execution of regression test plans, test cases, and test scripts
Experience with C#, .NET 2.0-4.5 Frameworks, PHP, Web Services, Web Servers (IIS and Apache), SQL Server 2008, XML, Windows and RedHat Linux servers, and scripting is a plus

QA Specialist Resume Examples & Samples

Perform all activities in compliance with company safety standards and SOPs
Write, review and approve Standard Operating Procedures in accordance with company policies
Participate in site activities associated with QMS programs (e.g., Validation, Complaints, and Change Control) and provide active input into shaping the future direction of these systems
Review and approve cGMP records (e.g., electronic batch record, change controls, NC, CAPAs, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation
Relevant experience (5 - 8yrs) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role
Experience with Regulatory inspections
Detailed Knowledge of applicable Regulatory requirements

Senior QA Specialist Resume Examples & Samples

High degree of organizational intelligence with the ability to identify key Functional Areas that contributes to the overall technical operations at Shire
Demonstrate unwavering ethics and respect for all customers. Practice open and honest communication, building authentic relations. The individual must be flexible to effectively embrace change. When faced with challenging circumstances, finds creative ways to ensure achievement of the desired outcome. Plans, organizes and communicates with others who may have concurrent work streams. Proactively improves customer service. Demonstrate genuine respect for others
Seeks greater understanding of self and others: seeks feedback about one’s own behavior Demonstrates leadership qualities
Works effectively in situations that are outside one’s usual activities and responsibilities. Fosters employee ownership and development by allowing others to make independent decisions and judgments
Works to drive engagement and accountability by demonstrating both qualities in day-to-day activities

Customer Service VOC QA Specialist Resume Examples & Samples

Develop reporting and track Customer Care Voice of the Customer (VoC) metrics. Distribute reports as needed
Review calls based on VoC responses. Follow up with Customers on outstanding issues as needed
Coordinate issue resolution for all levels of escalated issues
Coach Representatives/Supervisors on Customer complaints, processes, procedural issues
Identify customer experience improvement opportunities. Partner with Manager to meet with key business units to discuss gaps and possible solutions
Conduct QA monitors and review/analyze data and documentation
Facilitate calibration sessions to ensure scoring accuracy and share best practices for coaching and monitoring
Support new hire and on-going QA training initiatives as needed
Maintain regular and reliable attendance

QA Specialist Resume Examples & Samples

Two years of call center customer care experience, preferably in a technical environment
Proficiency with PC hardware and software (Word and Excel)
Demonstrated ability to work well in a team environment
Dedication to providing exceptional customer service
Self-motivated to achieve greatness in a fast-paced work environment

QA Specialist Resume Examples & Samples

Manage the activities of a defined team of QA specialist
Manage the QMS to ensure consistency of compliance actions, change control, quality reviews and audits/inspections are recorded effectively
Review all manufacturing records for completeness and cGMP compliance
Provide coaching and training for internal staff to promote improvements across the cGMP
Review and approve validation and qualification documents as necessary
Degree in Science or similar is required
Proven successful track record in a QA positive in the pharam API industry, ideally in a multinational fast paced environment
Good working knowledge of cGMP and QMS

Senior QA Specialist Resume Examples & Samples

High level of professional competence, preferably demonstrated by objective certification (e.g. Certified Quality Auditor or Engineer)
Strong technical/QA background so can work with contractors
Ability to deal with problems arising and maintain good relationships with third parties
Living the values at Shire is a basic expectation for all Shire employees/contractors. Shire expects all employees/contractors for live the BRAVE values

Apparel QA Specialist Resume Examples & Samples

Communicates Under Armour’s quality standards in easily defined, clearly understood methods and insures vendor factory management follow directions to insure the highest quality production. (mostly via email, but may travel overseas for onsite support)
Attend fit/style collaborations with Technical Design (Pattern Makers). Use detailed communication methods via Microsoft Word or Powerpoint to clarify critical construction details to global field teams that often have English as a second language
Assist in the development of CAPs (Corrective Action Plans) with Vendors. Able to discuss quality concerns & issues with factory management, monitor and provide feedback towards goal completion
Assist in development and implementation of proactive quality prevention systems with vendors. Verify effectiveness of the quality system through audits
Must be able to read and interpret technical data to include test reports; can communicate a recommended course of action based upon the test results
Works with QA Manager/ FTSG (Field Technical Services Group) to evaluate, approve, train, and certify existing vendor as well as new vendors on a planned timeframe during start-up period
Able to repeatedly and accurately use measuring tapes (in Imperial and Metric standards) to measure garments. Must be able to perform simple math equations to determine is a measurement is within or outside of a stated tolerance. Communicate statistical analytics based upon measurement findings (how many garments are in tolerance and the percentage found out of tolerance)
Build new relationships, promote teamwork and cross-functionally communicate effectively and efficiently with Technical Designers, Designers, PLM’s, Sourcing & Manufacturing, and other various contacts

QA Specialist Resume Examples & Samples

Coach Quality STAR point teams
Monitor Quality Metrics & Improvement projects
Facilitate Help Requests
Review prior day’s metrics
Complete Action on Accountability Board
Facilitate Help Request

QA Specialist Resume Examples & Samples

75% supporting on-the-floor manufacturing operations
75% Support of manufacturing operations including batch record review and management and review of deviation reports
15% QA consultation to manufacturing and support functions
10% Miscellaneous QA functions

QA Specialist Resume Examples & Samples

45% To provide QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with GMP and CTA requirements. Actively participate in project meetings as required. To be knowledgeable about the products supplied for clinical trials. Ensure complaints and deviations are fully investigated and documented. Release supplies in CSMD where appropriate
10% Ensure that all appropriate batch related documents are available in order to release the products
25% To communicate with contractors/suppliers regarding technical information and queries
15% Ensure the documentation systems to support Clinical QA Release activities are maintained. Prepare and/or update standard operating procedures and to ensure all Clinical QA SOP’s are reviewed in a timely manner
5% Ensure that GMP training is current and completed on time

Contractor & QA Specialist Resume Examples & Samples

To monitor and evaluate contractor performance
QA Specialist will provide in office support and assist with managing daily operations for contractors
This individual will have an increased focus on providing coaching, training, daily oversight and reporting of activities related to the installation and service activities provided by the Business Class Contractors
Research and track the overall quality of the Business Class Field Contractors performance, management and the services and data associated with each business partner
Participate in setting and following department goals, which provide excellent service, reliability and quality exceeding commercial customer expectations
Recommend and encourage creative and innovative solutions to support constant improvement of quality for Time Warner Cable
Interact closely with various other Departments throughout Time Warner Cable, as required
Review Contractor work orders and various reports in an effort to target invalid coding
Ensure Contractors are using the proper billing codes and rates at time of work order completion in the field
Process and apply chargebacks to invoices for coding errors, substandard work, failure to meet appointment times, and other Operational required penalties and adjustments
Interact directly with Contractor representatives to review errors, ensure timely reconciliation, and discuss disputes
Responsible for completion of weekly reporting (tracking), daily analysis, and review of work utilizing strong Microsoft Excel expertise and a close attention to detail
Additional responsibilities TBD
Experience working with third party vendor invoices and labor rates
Extensive knowledge of MS Excel with proficiency in Word, Outlook, Access and Power Point

Senior QA Specialist Resume Examples & Samples

Write, review and approve SOPs in accordance with company policies
Participate in site activities associated with QMS programs and provide active input into shaping the future direction of these systems
Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation
Documentation management, change control, NC/CAPA processes, internal auditing/self-inspection program, complaints, QMS and the overall quality management review process
Ensures that the self-inspection, audit and key compliance systems are effectively implemented, revised and optimised to ensure a continuous drive to improve product and process quality at the site
Oversee and maintain site inspection readiness program and for hosting of inspections
Manage inspection outcomes, including inspection response compilation and tracking
Oversee and implement Quality Agreements relating to area of responsibility
Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines
Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised Operating Standards and/or Corporate policies & procedures
Oversight and Mgmt of Quality Risk Mgmt Processes and for the embedding of QRM principles within the quality framework
Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, NC/CAPA processes, Documentation Mgmt
Responsible for trending programs associated with NC/CAPA, Change Control, Complaints, Periodic Reviews, QRM, ensuring that trend programs and outputs are providing key indicators as to program efficacy
Responsible for challenging current procedures and practices, interpretation of trend data and for making any necessary revisions to quality programs to afford optimisation and further development of existing quality standards and overall compliance
Degree in Engineering or Science related discipline preferred
Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry
Knowledge of applicable Regulatory requirements and experience with Regulatory inspections

QA Specialist Resume Examples & Samples

Reporting to the Senior Director of Global Product Regulatory Compliance Safety and Quality, the QA Specialist I will assist in the auditing of private label, equiity-brands and exclusive brand vendors' facilities with regards to compliance with QA/QC requirements including cGMPs and Proposition 65
As may be required, the QA Specialist I may be asked to arrange to have private-label, equity-brands or exclusive brand products tested for: (a) banned substances; (b) label claims; (c) contaminants, heavy metals, pesticide residues, known allergens, and/or known hepatotoxins; (d) presence of adventitious contamination resulting from the ingredients derived from genetic modification; and/or (e) use of ionizing irradiation to control microbiologic contamination
As necessary, the QA Specialist I will arrange for the company to have private-label, equity-brand or exclusive brand products tested by qualified laboratories using validated analytical methods, the cost of which will be borne by the vendor/s supplying the product/s
Support the implementation and maintenance of a robust multi-function controlled-access product files that will include the following information for private-label, equity brand and exclusive brand products: (a) full disclosure formulae (and formulae revisions); (b) product specifications; (c) raw ingredient Certificates of Analyses; (d) stability testing; (e) analytical testing; (f) labels; (g) claims; (h) claim substantiation; (i) government notification/registration files; (j) Certificates of Free Sale; (k) expiration or best before dating; and (l) vendor audit reports
Interacts with colleagues including representatives of Legal, Marketing, Sales, Business Intelligence, IT, Finance, Supply Chain, Category Management and QA/QC
Interacts on a cost-effective basis with outside regulatory/legal counsel, regulatory consultants, trade associations, suppliers and vendors
Develop an understanding to ensure compliance with the US. Foreign Corrupt Practices Act and the UK Bribery Act
Ensure all relevant parties companywide are kept abreast of any legislative and/or regulatory changes and the impact thereof
Clear knowledge and understanding of domestic and international legislation and regulation affecting conventional food, dietary supplements and OTC drugs, with particular emphasis on the United States, Canada, the EU, Israel, Turkey, and Russian-speaking markets
Experience effectively working with third-party analytical laboratories such as Covance, AEGIS, NSF International, etc
Ability to analyze agency rules and official regulatory communications, applicable case law, and current events
Excellent oral and written communication skills, including experience in effectively interacting, communicating with, and presenting concise analysis of technical issues to senior management
Strong interpersonal, technical and analytical skills
Demonstrated business orientation and focus in daily work; ability to establish instant credibility and work effectively cross departmentally to provide appropriate feedback to colleagues and management
A hands-on approach that encourages change and creative solutions
Ability to work well in a fast-paced environment
A Bachelor's Degree, preferably a BS in an applicable technical field, with excellent academic credentials
Minimum 1 year experience in sports supplements industry ideally within a compliance/regulatory/QA/QC role
Strong analytic, communicative, organization and implementation skills
Experience of working within a hands on operational role is a distinct advantage
Experience of working across continents and within different time zones is an advantage

BC Contractor QA Specialist Resume Examples & Samples

The Business Class Customers that are being provided these services range from home based business to large business; such as hospitals, hotels, governmental facilities and enterprise customers
The products that are provided and serviced range from basic broadband services to advanced fiber services
Research and track the overall quality of the Business Class Field Contractors performance, management and the services and data that each contractor company provides to Time Warner Cable
Ensure that all tasks that are assigned to the Business Class Contractors are accomplished in the safest and most effective, efficient and “customer-first” manner possible; while providing the best possible customer experience
Actively recommend and encourage creative and innovative solutions to support constant improvement of quality for Time Warner Cable
Communicate and enforce all company policies and procedures

QA Specialist Resume Examples & Samples

Obtain a detailed understanding of the behavior of (and issues affecting) the applications
Perform tests of new features and functionalities
Display ability to prioritize and resolve issues interfering with the User Experience
Write test cases and use tracking tools (JIRA) to file, monitor and resolve issues
Write automated test plans
4+ years using any defect-tracking tool. (Jira a plus)
Experience writing automated test plans
Experience with Javascript, Java

BC Contractor & QA Specialist Resume Examples & Samples

The primary quality control focus is the overall image that the Business Class Field Contractors present, the overall customer experience that is provided and the quality of the services and the data that is provided by the contractor companies for Time Warner Cable Business Class
The Business Class Field Contractors assist with tasks ranging from new installs, upgrades/downgrades, moves/relocations, disconnections, resolving service issues and Broadband and Fiber surveys and pre-wiring
Additional responsibilities include supporting temporary services at special events including conventions, trade-shows, company sponsored meetings/activities and emergency network service requests for local, state and national governmental agencies
Business Class Contractors also provide dispatch and construction liaison support to assist with managing daily operations. To monitor and evaluate contractor performance, the Operations QA Specialist must have experience in working with CSG/ICOMS, Salesforce, OSI, OMSE, Sage Quest and Work Assure

Benefits Admin QA Specialist Resume Examples & Samples

Recognize trending in call handling evaluations related client specific protocols and to specific functional knowledge areas, DB, DC, and H&W
Using results of evaluations and associated trending, recommend either additional training for staff or modification of procedures to increase efficiency, effectiveness or standardization
Provide supplemental coaching and feedback associated with Rep performance as requested
Raise awareness when performance standards fall below target levels, provide detailed analyses of the root causes and suggest options for corrective actions
Attend continuing Representative training and apply content in observation of systems and procedures and evaluation of SCS performance
Provide formal training sessions for Service Center Specialists
Responsible for ensuring compliance with applicable regulatory requirements
Take part in internal calibrations with peer group to remain aligned with quality standards
Facilitate client calibration sessions to quality standards with respective SBU teams and client subject matter experts
Assume SCS call handling responsibilities for respectively assigned client groups as needs arise
Ensure that systems, data and information are sufficiently accurate and reliable
At least 24 months call center experience, preferably in an outsourcing environment
Prior benefits administration experience, (multiple disciplines, DC, DB, H&W,) (preferable)
Proficient with Microsoft Office including Excel, Outlook, Access
Experience with quality monitoring programs and systems (preferable)
Strong understanding of call center metrics and statistical principals
Six Sigma certification (preferable)
Must have at least a High School Diploma or GED but PREFER Associates or BA/BS degree
Previous experience with PeopleSoft preferred
Payroll/HR experience is preferred. Workday Experience would be a plus as well
Previous experience with Business writing is preferred
Must be at least 18 years of age or older

QA Specialist Resume Examples & Samples

Monitors inbound and outbound telephone calls within call center(s) to ensure customer service meets quality assurance standards
Documents customer service quality issues according to procedure
Compiles reports pertaining to performance and quality assurance issues for review by management. Advises management, using written and/or verbal reports, in a timely and efficient manner
Contributes in learning sessions and other programs meant to educate call representatives on performance and quality assurance issues
Provides timely and efficient feedback on call quality

Senior QA Specialist, Disposition Resume Examples & Samples

6-8 years Quality Assurance experience supporting the manufacture and/or release of drugs, biologics, or devices at CMOs
Working knowledge of DP and FDP batch record review
Understanding of quality systems and cGMPs
Interpersonal skills and professional skills to interact with customers

QA Specialist, Digital Sales Operations Resume Examples & Samples

Provides technical support and troubleshooting in a timely and professional manner to internal and external customers across all performance related ad platforms and systems
Work with external ad vendors to review and test tags for varying rich media creative types and executions
Responsible for refining and managing NBCU’s QA process to ensure the delivery of high-quality, error-free deliverables. This includes recording metrics across the team, tracking missing creatives for Sales, Inventory and Operations, as well as maintaining a fluid schedule of roadblocks and sponsorships across the network
Responsible for monitoring all sites and devices to ensure ads are being delivered as intended
Assist with pulling and analyzing reporting to uncover potential errors/issues before they become revenue impacting. (i.e. error logs in FreeWheel)
Work directly with the Sr. Manager, Digital Sales Operations QA and management team to ensure that all details of sales operations are being upheld and that the Sales team is being properly supported
Basic understanding of web/Internet technologies (HTML, Flash, JavaScript, etc)
Strong knowledge of the digital media business
Strong analytical and interpersonal skills with ability to work independently and collaboratively

QA Specialist Resume Examples & Samples

75% - Support of manufacturing operations including batch record review and management and review of deviation reports
15% - QA consultation to manufacturing and support functions
10% - Miscellaneous QA functions

Senior QA Specialist Compliance Resume Examples & Samples

Develop and aid in development of solutions for moderate to complex problems
Contribute to the development of new concepts, techniques, and standards
Ensuring that practices are consistent with quality and regulatory standards

Dot-peoplesoft QA Specialist / QAS Resume Examples & Samples

At least 6 years' experience with software design, development and testing
At least 4 years' required experience with large-scale PeopleSoft HCM design and implementation
At least 2 years' experience hands-on expertise with Microsoft Office products including Project and Visio
Demonstrable outstanding verbal and written communication skills
Be conversant with the contract's functional requirements and ensure vendor compliance throughout all phases of the program
Participate in Business Process Design workshops and confirm results from workshops are accurately transitioned into requirements
Ensure that the OAKSenterprise RTM is complete and that the disposition of all requirements is accurately documented
Confirm the validity, continuity and acceptance of requirements' disposition throughout the Software Development Lifecycle (SDLC) process – Design, Build, and Test
Ensure that test scenarios and scripts are accurate and comprehensive to completely validate all OAKSenterprise requirements
Confirm that test scripts are appropriately defined, maintained, and updated throughout the System and User Acceptance Test phases
Validate that RTM requirements tie back to test scripts and confirm that all requirements have been successfully tested
Review, coordinate, and confirm the results of all phases of testing
Provide detailed review of deliverables for quality, technical accuracy and requirements compliance
Perform quality reviews as appropriate and needed with State participants and the contractor
Communicate all RTM modifications to project managers, business owners, stakeholders, and the program management office
Build and maintain relationships with program stakeholders, subject matter experts, and contractor representatives
Anticipate risks and issues and proactively address them
Effectively work and communicate with all parties participating on the program
Cooperate with, support the goals of, and execute direction with the State's executives and managers
Conduct and participate in meetings in accordance with high professional standards and effectiveness
Protect the State's best interests in all work performed
Detailed understanding of processes which support the software development lifecycle
Experience identifying and resolving issues with software quality
Experience with quality assurance roles and responsibilities
Experience with process improvement and procedures
Hands-on experience with performing and managing software QA phases and reviews of work products
Strong analytical skills and detail oriented
Complete tasks identified in the project plan
Participate in Discovery and Design sessions and ensure that requirements are met in accordance with the State's intent and are accurately documented in the RTM
Ensure decisions are being communicated to key project resources
Ensure that configuration and design decisions do not negatively impact the operational OAKS environment
Trace all requirements to their corresponding configuration and/or design documents and validate that requirements are fully met
Trace all requirements to their corresponding test scripts and validate that scripts fully test the requirements
Work with Application Teams during pre and post assessment periods
Identify and mitigate program risks
Identify and resolve program issues
Ensure that defined processes are followed
Resolve conflicts with sensitivity and tact
Effectively coordinate tasks and communicate with contractor, program staff, and stakeholders

CPS SG Process QA Specialist Resume Examples & Samples

Ensure manufacturing processes/process quality activities are followed in compliance with KORE & ISO, GMP and local regulation requirements by developing & providing SOP’s for plant processes and timely technical support and decision on the quality problem, observation to protect product’s integrity and specification and final disposition of customer complains/feedback
Establish and maintain an effective, governed and documented system for all company processes, which is integrated compliant to its entire applicable standard references and capable of meeting company requirements continually
Evaluate new packaging material and ensure the packaging fitness for use and handling of all packing material documentation which is part of quality system
Bachelor of science or postgraduate degree, major in the subject of chemistry or food science, or biochemistry
Minimum experience is 5 years prior experience in quality assurance role in a food/beverage or pharmaceutical industry
Knowledge of concentrate manufacturing and quality system, project management experience; strong GMP experience, problem solving skills. Strategic-thinking, planning, organizing and executing skills
Knowledge of local food laws/regulations

QA Specialist Resume Examples & Samples

Managing the product stability programme
Monitor the operations at the Contract Manufacturer. Perform batch review, review product complaints, deviations, change controls and product related investigations
Support the product complaints system
Review and approval of product artwork
Assisting in preparation of Annual Product Reviews
Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA's)
Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
Maintain appropriate Quality Technical Agreements with all GxP vendors
Supporting regulatory submissions

Senior QA Specialist Resume Examples & Samples

Investigating out-of-specification (OOS) reports & deviations
Act as lead auditor in third party vendor audits, to include: GMP contract manufacturing, analytical testing, and storage locations when required to ensure compliance with requirements and country specific regulations
Be a key member of company audit team during regulatory or customer audits
Operate the CAPA system
Develop and write SOPs & controlled documents
Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company
Report Quality Metrics
Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements
Contribute to management of the supplier approval programme and to maintenance of the external audit schedule
Assist with troubleshooting quality issues at Partner's or vendor's site or associated with technology transfer, when required

QA Specialist Resume Examples & Samples

Provide quality assurance (QA) on all campaign launch/modifications across the NBC Entertainment Portfolio and providing critical troubleshooting on major campaign launches
Assist in identifying areas of weakness across the operations team and help in preparing and training the Ad Operations Campaign Specialists on changes to process and reoccurring issues
Familiarity with ad-serving systems (FreeWheel, DFP-P, etc.)
Innovative thinker with acute awareness of managing competing initiatives
Ability to set and self-manage goals, deadlines and multiple assignments concurrently in a project based environment

QA Specialist Resume Examples & Samples

Be the quality focal point for the supplier activities directed toward process control and quality assurance of sourcing products, work with supplier to establish a structured approach for consistency and adherence to quality procedures and requirements
Conduct management system assessment at the factory to ensure compliance with local and internal requirements
Engage Suppliers and Factory level leadership in necessary corrective action plans to mitigate risk and to continuously improve system of the factory operation
Provide training to internal and external partners throughout the Asia region regarding company expectations on suppliers and their factories
Complete job report with qualitative and quantitative data in time
Support line manager to train new team members and dedicate to project work assigned by management

Senior QA Specialist Resume Examples & Samples

Planning and implementation of Test Plans for functional and non functional testing
Assist in the designing and implementation of automation frameworks
Identify and highlight ways to continuously optimise the way in which QA function operates to create an efficient, scalable team
Work with the business and Production Support to capture requirements, investigate issues and trap defects with regression tests
Hands on, Senior Testing / QA experience, proven experience of test cycle and release management
Experience of working within a global functional QA Test team within the financial sector or for major bank or client
Experience with high-volume low-latency highly available IT systems, understanding of their architecture and SLAs
Strong knowledge of test methodologies and experience of implementing best practices
Demonstrable knowledge of Java, Ruby, Unix, Unix scripting, SQL, Python (desirable)
Experience with test automation tools. Proven track record in successful automation of the testing for large platforms

QA Specialist, Product Resume Examples & Samples

Obtain a detailed understanding of the behavior of (and issues affecting) Showtime Anytime and the SHOWTIME standalone service across all platforms
Perform tests of new features and functionality of Showtime Anytime and the SHOWTIME standalone service
Prioritize and collaborate to resolve issues interfering with the customer experience
Write test cases and use tracking and debugging tools to file, monitor and resolve issues
3+ years directly testing and/or supporting web and mobile media applications
3+ years using any defect tracking tool (Jira a plus)
Experience testing LID and game console apps for devices such as Roku, Amazon Fire TV, Apple TV, Xbox, and Playstation
Experience testing browser compatibility across both Mac and PC platforms
Experience using developer/debugging tools such as Xcode, Charles and Wireshark

QA Specialist Resume Examples & Samples

Responsible for day to day activities designed to maintain and enhance the local Quality Management System for 3rd Party and Commercial oversight in line with directive 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively ,Medical Device Directives, ISO13485 as applicable
Support the continuous improvement of the QMS including the development and implementation of improved quality reporting measures
Effective management and coordination of Quality Management Systems including change control, Deviations, CAPA, SOP's
Interface between Regulatory Affairs, Marketing and Customer Service personnel where necessary
Management of customer complaints, Adverse Event reports and Medical Information enquiries and forwarding to relevant parties for processing
Responsible for the writing, training and management of SOPs including associated training requirements
Maintenance of system to ensure appropriate review and completion of Annual Product Quality Reviews
Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required
Coordinating quality related customer complaints , where necessary liaising with quality team to close such complaints as applicable
Provide direct support during competent authority audits
Assist in conducting internal self-inspections and external audits as appropriate
Quality review and approval of artwork components where applicable
Review and co-ordination of batch records and associated documentation including the generation of product certificates to support batch release and certification of product

QA Specialist Resume Examples & Samples

Responsible to review requirements, specifications, Detailed designs and UI documents related to the call flows
Responsible for walkthrough sessions with designers\developers, test case designing, scripts fine tuning in Cyara, and E2E automation using various automation tools
Responsible for scripts designeviews, test plan preparations, test coverage matrix preparation, data mining activities
Participate/host calls independently with business and development teams
Coordinate\Triage with Dev teams on defects identified during the testing; should be able to analyze any problem during configuration/ testing and act as escalation point until the issue resolution
Responsible for creating release level test reports, KT documentations for owned modules and KT sessions within the team
Suggest process improvements to achieve or exceed desired quality
Work on multiple and complex concurrent tasks
Candidate should able to test the application in both English and Spanish languages. Good ability to Read\Write\Understand the Spanish language. Spanish language fluency required
5-7+ years of experience years of professional experience in software testing (both Manual and Automation)
Experience in the complete Software Development Life Cycle (SDLC)
Extensive Experience in testing life cycle, and testing processes
Experience in application functional testing. and hands on experience in any one automation tool (QTP, SoapUI, RIT etc)
Hands on experience in Quality Center\ALM
Experience in IVR and contact center functional testing
Knowledge with UI design documents
Hands on experience in VB or Java Scripting
Work experience with Hammer\Cyara tools
Good data mining knowledge

QA Specialist Resume Examples & Samples

Batch Record Review & material release to ensure compliance with GMP requirements
Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints
Carries out tasks related to the management of batch records design and approval
Carries out administration of the SAP Quality Management Module
Carries out tasks relating to the management of site change control systems
Compiles Annual Product Reviews
Supports all validation activities on site as described in the Site Validation Master Plan
Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.)
Supports system qualification and process validation activities
Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site
Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
Perform GMP audits on-site and vendor facilities as required
Carries out tasks related to the administration of site supplier approval process

Junior QA Specialist Resume Examples & Samples

Execute and verify a wide range of quality-control tests the ad products to ensure that specified standards and end-user requirements have been met
Log defects, identify course of action and while providing all necessary information into Jira
Continuous refinement of QA process to ensure the delivery of high-quality, error-free deliverables
All test devices must be updated, charged, and reset as necessary to maintain a current and available pool of testing devices
College degree is required
Experience working in a QA role a plus
Knowledge in testing tools and best practices are preferred
A positive attitude with strong work ethic
Self-starter capable of working independently or in groups
Experience or exposure to Agile/SCRUM is ideal, but not required
Exposure or an interest in tools like JIRA, Confluence, etc. are preferred
Automation experience is nice to have, but is not required (Java, Ruby, PHP)

Senior QA Specialist, Information Management Resume Examples & Samples

Strong understanding of Agile (Scrum) and Waterfall methodology practices
Work with Project Manager and Scrum Master to define the project's testing methodology and manage the test execution for small to large sized projects
Work alongside business and development partners to deliver solutions for internal and external customer facing application using an Agile framework
Develop and execute the following for BI (Business Intelligence), DW (Data Warehouse) and Data Integration projects: test strategy, risk assessment and mitigation, test estimation, project planning and identifying test goal as per sprint, test scenarios / user stories / test cases, test data strategy, defect tracking, test coverage (traceability matrix), status report / dashboard metrics, test summary completion report
Create and maintain complex and re-usable SQL queries (such as type 2 triggers, all types of joins, aggregations, groupings, analytics functions, etc.)
Work collaboratively with test teams composed of staff drawn from various IT, business units and 3rd party resource providers
Lead and monitor the testing execution for each sprint (Agile) or testing phase (Waterfall)
University degree or college diploma in computer science or related discipline
3 + years QA experience
Experience leading integration efforts on projects with 5 or more integrated systems
Experience with data integration, ETL, BI, DW and big data testing
Solid testing experience with a variety of business applications executing in a variety of operating environments (platforms)
Able to mitigate unexpected change and be able to communicate impacts as well as possible options to recover
Strong experience with Oracle, XML, SOAP UI, SQL, DB2, Unix shell scripts, Mainframe ESP and Enterprise Service Bus (ESB)
Exposure with test management and agile tools such as: HPQC, Jira, etc
Experience with automation (wrappers) i.e. SHELL or PERL scripting would be an asset

QA Specialist Resume Examples & Samples

Understanding the functionality, features and limitations of the OncoEMR application suite
Researching and understanding current issues and technical bugs in the software
Working with the engineering team to ensure the software is appropriately coded and designed
Create and document test plans and scenarios to test all aspects of our products
Test the limits of software at both the project and application level, including integration with related applications
Work with the engineering and customer support teams to recommend possible solutions and resolve issues
Act as an expert on OncoEMR and its capabilities

Project Management QA Specialist Resume Examples & Samples

Monitors the PM reporting and PM control environment within the bank. This includes performing recurring project/program QA activities to evaluate adherence of project/program execution against expectations of PM Corporate Standard. This includes the publication of QA reports which provide clear and concise insights on issues and risks which will assist management in fulfilling its responsibilities
Identifies and implements improvements to the PM QA processes, procedures and overall PM control environment based on input from key stakeholders. Supports assessments and collaborates with other parts of the Bank (e.g., Finance, Technology, Corporate Audit, and Line of Business Groups) to develop recommendations to improve BMO’s project delivery capabilities
Administers QA aids, templates, and plans
Drives positive change in the Enterprise based upon high quality work, thoughtful in its preparation and direction
Continually advances the professional practice. Be and be seen as knowledgeable with specific expertise in project/program delivery. Supports EPMO leadership in maintaining an effective center of competency, and Corporate Support Area
Effectively manages conflict when it arises with stakeholders and colleagues or escalates as needed
Possesses a university degree/college diploma and/or 5+ years relevant work experience
Knowledge of PM and demonstrated PM and / or project coordinator skills
Knowledge of project risk management
Holding a valid PMP designation from the Project Management Institute (PMI) is an asset
Understanding of financial industry regulations, including audit, risk management and OSFI/OCC specific requirements is an asset
High level of knowledge in internal controls and operational risk assessment is an asset
Excellent problem-solving and critical-thinking skills to recognize and comprehend complex issues, policies, regulatory requirements and industry information affecting the business environment
Demonstrated attention to detail and high level of accuracy
Demonstrated presentation, written and verbal communication proficiency
Demonstrated relationship management and interpersonal skills proficiency
Demonstrated initiative, energy, and ability to work independently and to establish priorities
Is an exemplar of Being BMO behaviors and their related outcomes
Exhibits proficient knowledge of BMO business standards, operational processes and PM methodologies
Proficient in Microsoft Office productivity suite (PowerPoint , Excel, Word, Visio and Project)

QA Specialist Resume Examples & Samples

Bachelor degree in Pharmaceutical science or Science-related field
3-5 years of QA experience
Problem solving skill and have understanding in GMP requirement

QA Specialist Resume Examples & Samples

Responsible for implementation of document control activities and ongoing efforts related to document control
Implement process improvements as they relate to quality system compliance with ISO/GMP requirements
Manage internal audits and schedule
Establish and maintain CAPAs
Must communicate effectively and interact with customers and vendors when necessary
3 to 5 years experience in quality assurance in medical device manufacturing, including exposure to FDA/ISO/TS requirements and systems
Specific experience in driving compliance of quality systems
Past experience in quality system and internal audits a must
Hands-on experience in implementing QS/ISO quality systems as related to the medical device industry
Familiarity with CAPA systems
BS in Life Science or related field
Experience with root cause analysis, document control is preferable. Familiarity with medical device manufacturing helpful but not required
Certified auditor a plus
The employee must occasionally lift and/or move up to 10 pounds

RA / QA Specialist m/f Resume Examples & Samples

Minimum 2-3 years proven RA and/or QA experience with medical electrical devices in an FDA-regulated industry; or equivalent combination of education and experience
International experience in problem solving, complaint handling or equivalent
Bachelor's degree (BA/BS) from four-year college or university in science, engineering or equivalent

Senior RA / QA Specialist Resume Examples & Samples

Critical review and analysis of customer complaint technical data
Perform root cause investigation to identify potential failure modes and failure mechanisms using appropriate root cause analysis techniques
Participate in the preparation of documentation required for reporting to regulatory authorities in relation to customer complaints
Excellent written and verbal communication skills with the ability to target communications to the audience
Experience in working in a highly regulated environment, preferably in the medical industry
Previous experience with medical devices comprising both hardware and software
A collaborative and flexible approach
High ethical standards
Ability to handle multiple tasks/projects and manage priorities accordingly
Degree in science or engineering related field

Senior QA Specialist Resume Examples & Samples

Reviews and approves method validation and stability protocols, and reports
Reviews and approves CTM specifications, raw material, finished product COAs, batch records, and related documents
Conducts vendor qualification(s) for Analytical Services, as assigned
Performs internal systems audits and issues audit reports
Facilitates OOS investigations, reviews and approves completed investigation reports
Facilitates manufacturing deviations and investigations
Monitors compliance to DEA license requirements
Monitor sand tracks corrective and preventive (CAPA) investigations and commitments to internal, client, and regulatory audits
Complies with all relevant cGMP/GLP regulatory requirements while carrying out assigned tasks

QA Specialist Resume Examples & Samples

Manage the supplier qualification program to ensure compliance to regulatory and quality system requirements
Manage the review of records for reagent manufacturing to ensure compliance and assist in developing and implementing training for personnel as the Company moves to IVD products
Assist with equipment and process validation to ensure that protocols and reports are adequately documented and testing is performed
Manage audit program (internal/supplier) and assist in third-party (regulatory, customer) inspections and audits to ensure compliance and ongoing certification
Have fun, be fully engaged and promise to have a life beyond “work”

QA Specialist Resume Examples & Samples

Review clinical manufacturing, packaging, and labeling drug product batch records, in-process quality control data, assess completeness of change controls, deviations, and test results for timely disposition of drug products intended for human clinical use and issue material status notifications
Interact with key stakeholders such as Formulation and Development, Clinical Packaging & Labeling, Clinical Supplies Management, and Regulatory Affairs as needed to facilitate product release
Other duties as requested
Excellent attitude with good verbal, written, and interpersonal communication
Ability to multitask and easily adapts to changing priorities Self starter, able to work with minimal supervision
Experience in Pharmaceutical manufacturing
Experience working with contract manufacturers is desired

QA Specialist Resume Examples & Samples

Responsible for daily activities and ensure continuous improvement in the area of inspection preparedness, training, EET/CAPA tracking, metric reporting, and system design, implementation, and optimization
Lead/participate in project team to streamline Clinical QA processes and SOPs by reviewing existing workflows and identifying areas for improvement
Perform SOPs periodic review, write/revise SOPs and design process flowcharts
Provide QA support for the design, implementation, integration, and continuous improvement of key software solutions (TrackWise, LIMS, EBS, and Gilead’s batch disposition, business analytics, and CXO interface tools)
Responsible for ensuring CAPA/ audit observations responses are appropriately implemented and closed in a timely manner
Coordinate inspection and audit support for Clinical QA during internal / regulatory inspections and audits
Review and may approve change control requests, investigations, and proposed corrective and preventative actions to ensure compliance with Gilead procedures, cGMP and all other applicable regulations
Manage Clinical QA training requirements and curricula, OJT qualification programs, and New Employee Onboarding programs to drive improved employee qualification and training compliance
Review existing quality workflows and assist in identifying areas for improvement. Write, revise and may review standard operating procedures
In depth knowledge of Quality Systems and international cGMP standards
Excellent attitude with good verbal and interpersonal communication skills, excellent judgment, and multitasking skills who can work well in a dynamic environment
Strong leadership and negotiation skills
An accountable leader who is detail and quality oriented with a solid understanding of quality principles, methods, and procedures
Working knowledge of GMPs and regulatory requirements (US, Canada, and EU)
Technical writing skills

Senior QA Specialist Resume Examples & Samples

Leads laboratory quality activities for analytical development, quality control, and contract labs across the clinical and commercial supply chains
Reviews and approves laboratory exception events (e.g. investigations, deviations, CAPA), change control, test methods, and specifications; ability to coach and train cross-functional colleagues (AD and QC) to ensure cGMP compliance to these specific areas
Reviews, approves, and coordinates audits of analytical and stability data in regulatory filings and data generated by AD and QC labs. Prepares and manages team schedule for this activity and tracks to ensure timelines are met
Proactively leads internal and external audits and assures that analytical and stability testing data, laboratory systems and controls are reviewed and correct to assure compliance, and continuous improvement opportunities are identified and implemented
Proficient in and maintains awareness of laboratory controls per FDA and EU cGMP guidelines
Leads a wide variety of Quality Assurance activities to ensure compliance with applicable US and international regulatory requirements
Expertise in leading daily QA team activities including planned changes, deviations, investigations, and provides on-going support and training to more junior staff members in these areas
Reviews and approves QC and AD validation efforts from phase 1 through commercial and proficient in method validation and method transfer guidelines per ICH and USP
Reviews and improves existing quality procedure workflows, identifies areas of improvement for efficiency and compliance, and leads implementation efforts in collaboration with cross-functional stakeholders
Serves as QA project lead, leads complex quality investigations/deviations, represents QA on Materials Review Boards, and independently authors or approves concise quality investigation reports with appropriate corrective action and preventive actions (CAPA)
Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits
Possesses at least 7 years of practical experience in a pharmaceutical GMP analytical testing laboratory
Bachelor’s degree in chemistry, microbiology, or related scientific field. M.S. is preferred
Expertise in Quality Systems and cGMP standards applicable to clinical and commercial products and AD/QC laboratory operations
Prior participation in regulatory inspections and knowledge of European regulations is desirable
An accountable team player and leader who is detail and quality-oriented with solid understanding of quality assurance principles, systems, methods and procedures
Proficiency in small molecules and solid oral dosage forms is preferred
Excellent technical writing skills when creating and presenting reports
Ability to work independently and effectively coach peers in a high-paced environment with tight timelines, while maintaining accuracy and quality
Ability to effectively present data, findings, improvement initiatives/projects to QA and cross-functional leadership
Proficient in data acquisition and LIMS systems such as Empower and Labware is highly desired,
A relevant background in Quality Control or Analytical Development with a role as a supervisor or manager is highly desired
Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications
May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products
Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes
May assist or lead compliance audits as required. May interface with regulatory agencies as required
Proficient in GMPs and/or GLPs
Proficient in application of QA principles, concepts, industry practices, and standards
Demonstrates ability to effectively manage multiple projects/priorities
Has proven analytical and conceptual skills
Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
Demonstrates excellent verbal communication, technical writing and interpersonal skills
Demonstrates working knowledge and good proficiency in Microsoft Office applications
Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial
Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial

Senior QA Specialist Resume Examples & Samples

Leads quality review of validation activities for analytical operations, and contract labs across the clinical and commercial supply chains
Reviews and approves validation related laboratory exception events (e.g. investigations, deviations, CAPA), change control, test methods, and specifications; ability to coach and train cross-functional colleagues (AD and QC) to ensure cGMP compliance to these specific areas
Reviews, approves, and coordinates review of validation projects. Prepares and manages team schedule for this activity and tracks to ensure timelines are met
Reviews and approves QC and AD validation efforts from phase 1 through commercial and highly experienced in method validation and method transfer guidelines per ICH and USP
Possesses several years of practical experience in a pharmaceutical GMP analytical testing laboratory focusing in validation
Prior participation in regulatory inspections and knowledge of European regulations is desirable pertaining to validation of analytical methods
Proficiency in phase appropriate validation of small molecules and solid oral dosage forms is required
Advanced technical writing and excel skills are highly desired for creating and presenting reports
Ability to effectively generate metrics, and present; data, findings, and improvement initiatives/projects to QA and cross-functional leadership
Proficient in data acquisition and LIMS systems such as Empower and Labware is highly desired

QA Specialist Resume Examples & Samples

Recognize exemplify and adhere to ICON's va lues which center around our commitment to People, Clients and Performance
As a member of staff, the employee is expected to embrace and contribute to our culture of process
Improvement with a focus on streamlining our processes adding value to our business and meeting client needs
The individual will recognize the importance of and create a culture of process improvement with a focus on streamlin ing our processes adding va lue to our business and meeting client needs
Conduct or lead project specific and internal (process I system) audits
External (client) audits and Supplier Audits
Develops Audit Records and Reports
Conduct QA review of SOPs
Updates and trains employees in regu latory compliance
Review and approval of Systems Development life Cycle (SOLe) documentation to assure regulatory compliance
Assesses system related procedures for data co llection relat ive to study protocol
Reviews documentation with respect to study protocol and applicab le procedures
Serve in Inspection Coordinator Role providing timely response to management and clients
Provides periodic reports as needed to Quality Assurance Management
Willingness and ability to travel for off-site activities as needed
Conduct special projects I tasks as assigned (i.e, process improvement, trends analys is etc.)
Travel (approximately 10%) domestic and/or international
May be called upon to oversee other QA personnel when acting as a lead auditor or leading a process improvement project or initiative
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily . The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
A minimum of 3 years of quality assurance experience in pharmaceutical, biotech or eRO fields
Able to work with teams and independently
Strong audit ing experience
Working knowledge of current GCPs (GLP/GMP may be considered with other experience),
Working knowledge of 21 CFR Part 11 and auditing against the regulation
Working knowledge of SDLC methodology and ability to audit systems against the methodology and applicable regulations
Must possess excellent project management skills
Excellent computer, documentation and communication skills are required
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on Ihe employees' location, the employee may be required 10 possess a va lid Drivers' license
Bachelor's degree or local equivalent (A 2 year degree or sufficient work experience. business role acumen or QA Certification) or local equivalent

QA Specialist Resume Examples & Samples

Reviews completed manufacturing, filling, and labeling records, and analytical data for conformance to regulations, SOPs,
Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions
Reviews, edits, and approves change control and SOPs
Reviews, edits, and approves new and revised master manufacturing records
Reviews, edits, and approves validation protocols and executed protocol reports
Performs hands-on monitoring of production and non-production activities and notifies area and Quality Management of any observed non-compliance
Requires BS/BA in scientific discipline or related field and minimum 2 years relevant experience. Will substitute relevant experience for educational requirement

QA Specialist Resume Examples & Samples

Participates in data driven risk assessments and risk reviews (risk identification, analysis, and ranking)
Helps formulate strategies for risk mitigation and control
Prepares and revises documentations, including reports and forms
Assists with developing and improving the quality system
Requires BS/BA in the Biological Sciences, Chemistry, Biochemistry, Engineering or related field, and 2+ experience with manufacturing, development of manufacturing processes, or quality assurance

QA Specialist Resume Examples & Samples

This position may require international travel
Knowledge of Clinical or Commercial Filling compliance
Language skills in French and/or German a plus
Ability to manage conflict with tact and diplomacy
Strong interpersonal written and oral communication skills

QA Specialist Resume Examples & Samples

Primary duties include QA support for commercial filling, labeling, and CMOs
Performs AQL vial inspections
May supervise lower level employees
Requires BS/BA in scientific discipline or related field plus minimum 4 years of relevant experience. May consider significant industry experience in lieu of educational requirement

QA Specialist Resume Examples & Samples

Performs inspection and labeling of released raw materials
Prepares appropriate documentation and executes release of acceptable vendor materials
Reviews completed analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Performs hands-on monitoring of outgoing product shipments, cell vial transfers and disposals
Initiates, reviews and closes Supplier Corrective Action Reports
Off shift schedule (nights) and weekend work is required
Good organizational skills and attention to detail
Requires good written, verbal and interpersonal communication skills and the ability to effectively interact with all levels
Solid computer skills and abilities
Ability to work a varied schedule including off shift and weekends
Hours for this position may include weekend and/or evening hours*
Requires BS/BA in scientific discipline or related field and minimum 2 years relevant experience

Software QA Specialist Resume Examples & Samples

Develop, manage and write test plans that provide comprehensive test coverage for small to large and complex projects
Provide assistance with system development life cycle (SDLC) activities, write SOPs for SDLC procedures
Use requirements documentation and other specs to create test scenarios that serve as acceptance criteria for the software product
Create and execute test cases, scenarios, and scripts using both manual and automated testing techniques to conduct functional and regression testing
Manage defect reporting using defect tracking tools
Produce test summary reports
Participate in requirements gathering and develop test design
Develop test strategies for multi-tier and scalable applications running in the server, desktop and mobile environments
Incorporate methodologies that exercise system, integration and boundary testing
Ensure traceability between software development products including requirements, designs, test plans and test procedures
B.S. or higher degree in Computer Science or other technical field with 6 years of experience with at least 5 in performing analysis and testing through a full system development life cycle

QA Specialist Resume Examples & Samples

Working as part of the Quality Assurance team on site ensuring that products are manufactured, stored and packaged in accordance with cGMP
Interfaces with the Project core team to provide technical expertise for all QA and Compliance topics relating to facility, utility and equipment design, qualification, new product introduction, product manufacture and supply
Provide Quality review and oversight at project concept, design verification, commissioning and qualification activities including assisting in resolution of issues
Develop and support PAI and Operational readiness plans to ensure successful implementation of commercial products to site
Participate in the preparation and review of documentation to support project schedule
Ensure practises meet cGMP requirements
Third Level Degree in Science or a related discipline preferred
Very good knowledge of cGMP in a regulated environment ideally
Detailed knowledge of quality management systems
Competent knowledge of facility/utility/equipment/process/cleaning/computer systems qualification, new production introduction and commercial manufacture for sterile manufacturing facilities
Competent knowledge of risk assessments and application of risk-based approach
Capable of troubleshooting issues associated with projects, process development etc
Planning and organising skills
Understands KPI’s for the team and the site
Minimum of 3 years’ experience in a similar role
Experience working in a GMP environment is required
Flexibility to travel required with this position

QA Specialist Resume Examples & Samples

Interfaces with support departments to provide technical expertise for all QA and Compliance topics / issues relating to product manufacture and supply
Develop and support audit readiness plans
Measure and report RFT / trend data and work with team to resolve recurring issues
Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
Perform critical/ constructive review of procedures and practices
Third Level qualification (degree in science or related discipline preferred)
Very good knowledge of cGMP in a regulated environment

QC / QA Specialist Resume Examples & Samples

Provide information on products and raw materials for operation when critical quality issues arise. Participate in the sourcing of alternative supplier and perform supplier audit to support PPIC and procurement team
Approve Production Order (formulation) to production team. Revise and Update the recipe (BOM) and revise PMR as necessary
Confirm that plant quality control procedures are properly carried out. Ensure that all required inspections and tests are carried out in accordance with current procedure outlined in the Product Manufacturing Requirements (PMR) and meet QC spec
Perform final evaluations of serious inquiries or customer complaints on sub-standard products in order to find best resolutions and maintain good company image. Conduct investigation to find the root cause and give good solution. Evaluate quality of product to achieve marketing objectives and customer requirements
Monitor regular control to check the condition of stocks, properly handle management of ageing stock and propose provision of obsolete stock and inform to Production Department if there are any stocks which can be reworked
Monitor and ensure QC equipment is in effective working order and calibrated at specified intervals
Participate in the internal and external site audit, and ensure issuance, periodical update and preparation of the Quality Control manual, procedures and instruction in order to provide the accurate guidelines for all relevant staffs
Ensure a safe work environment and safety procedures are followed
Maintain Product Stewardship following Responsible Care program

100

QA Specialist Resume Examples & Samples

Maintaining production documentation of all manufactured and packed products
Providing opinions, regular control and approval of technical and technological instructions of the products and ensuring alligned and compliance of production documentation with regulatory requirements
Initiating and leading all activities related to aberrations
Initiating, providing assessment, implementing and supervising all corrective activities and also providing supervision for all preventive actions
2-3 years of experience in pharmaceutical manufacturing industry
Very good knowledge of Polish pharmaceutical law
Fluent English (both speaking and writing)
Proven track record in leading cross functional teams

101

Health Care Claims QA Specialist Resume Examples & Samples

Identify error trends that may be used for training and coaching opportunities
May mentor less experienced associates within the Quality Assurance Department
3 years of quality assurance and/or health care experience
1 year of claims adjudication experience
Post-secondary education; 3 to 5 years quality assurance and/or health care experience including one year of claims adjudication experience Is preferred

102

QA Specialist Resume Examples & Samples

Certified Quality Auditor (ASQ), registered RQAP-GLP (SQA) or certification/registration in another recognized and relevant organization. A college degree in chemistry or related science or an equivalent combination of education and experience
At least 5 years of QA experience is required. QC or senior scientist experience may be substituted for part of the QA experience
Or equivalent combination of education, training and experience that proved the individual with the required knowledge, skills, and abilities
Bilingual Spanish
Expertise in one or more specialized areas relevant to QA activities, e.g. computer systems, root cause analysis, TQM
Good verbal and written communication skills are necessary
Must be detail oriented and able to set priorities
Minimal supervision is required
Interactions with supervisor are primarily to inform the supervisor of activities
Basic computer skills (Word Processing, Excel, etc.)
Ability to handle multiple priorities, tight deadlines and changing priorities

103

QA Specialist Resume Examples & Samples

Be a certified Quality Auditor or be certified / registered in another recognised / relevant organisation
Possess a degree (or equivalent) in a relevant science-based subject
Have relevant quality assurance expertise of GMP regulations gained from time served in pharmaceutical, biotechnology and /or medical device industries
Demonstrate experience of providing customer related QA services preferably in a contract service environment
Possess strong project management skills
Have the ability to handle multiple priorities and deadlines
Have knowledge of EU GMP regulations, 21 CFR 210/211 & 820 regulations, 21CFR11 regulations and international GMP regulations

104

Senior IT QA Specialist Resume Examples & Samples

Test planning for projects and enhancement releases
Test scenario and test case design and execution
Record all test results with the appropriate level of details
Identify and document crisp and detailed defects
File new defects based on behaviors found during regression / verification
Ability to identify issues and work on them to closure
Perform Functional, System Integration and Regression testing using automated/manual methods
B.S. or M.S. in Computer Science/Engineering or Equivalent
5+ years’ experience in Software Quality Assurance or Software Development field
3+ years’ experience performing testing activities for various platforms ERP, SFDC, Renewals, Quoting, Marketing, Licensing and other applications
Experience with Subscription (I.e., Zuora) based application/solution
Knowledge of billing and usage application
Experience with Oracle databases using SQL or PL/SQL
Experience in validation of data flows and integrations of multiple upstream and downstream applications using EAI, TIBCO or Fusion middleware
Experience with designing Test Cases covering functional, integration and end-to-end testing
Self-motivated, able to work independently, and perform multiple tasks
Result oriented and have a high degree of accountability, commitment, and responsibility
Effective written/oral communication
Able and willing to work with Business and Project teams in USA, Asia Pacific or Europe including outside of normal working hours
Able to work and deliver on multiple projects simultaneously in a fast paced environment
Must demonstrate good time management skills and be able to prioritize work to successfully meet all deliverables and timeframes

105

Junior SW QA Specialist / Application Tester Resume Examples & Samples

Detail oriented and able to follow procedures
The ability to develop detailed system and integration level test procedures
Ability to work well with team members across multiple organizations, and possess strong oral and written communication skills

106

QA Specialist Resume Examples & Samples

Bachelor’s degree (or equivalent) required in a relevant scientific discipline
Relevant quality assurance experience (comparable to 10+ years) including expertise in GxP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry
Demonstrated experience providing customer-related QA services preferably in a contract services environment
Possess or working towards a Certified Quality Auditor designation or be certified/registered in another recognized/relevant organization
Or equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the duties of the job
CRO Quality experience preferred
Expertise in all aspects of pharmaceutical GxP regulations (e.g. quality systems, root cause analysis and Total Quality Management) including international regulations
Proficiency in Computerized Applications Systems (similar to TrackWise, Word, Excel) highly preferred
Above average negotiation and conflict management skill

107

QA Specialist Resume Examples & Samples

Establish a culture of quality and testing within the infrastructure group
Design and develop automation architecture, scripting
Design automation scripts to interface with additional scripts for startup, cleanup, logging, reporting and to reduce maintenance
Responsible to ensure that all planned activities are implemented, executed and completed in accordance to the planned timeline
Work with other QA teams, Business Analysts and Solution Analysts to validate requirements and incorporate the requirements for the design and development of the automation test scripts
Attend QA team meetings and articulate any concerns and findings as well as report those concerns using standard problem reporting tools
Candidate must be able to read Requirement Specification documents and produce Test Plans and Test Cases,
Candidate must be able to define automation Strategies that will verify the operation of new services or products while tracking to project schedule

108

QA Specialist Resume Examples & Samples

Support preparation activities for review of the system and management review
Support in the preparation of annual reports, annual product reviews and core documents
Supplier qualification and internal quality review
Investigating out-of-trend/specification reports
Conducting of internal audits and/or coordinating the self-inspection program
Provide support for the product artwork process
Maintain up to date Quality Technical Agreements with all vendors and take on other activities/responsibilities as required due business needs

109

QA Specialist Resume Examples & Samples

Primary Skills Information Quality Asurance / Software Testing
Top Critical Skill - Testing / 0 - 2 years
Second Most Important Skill / Years of Experience Quality Assurance / 0 - 2 years
Third Most Important Skill : Soft Skills
Good communication / Analytical skills/ Detail-oriented / Decision-making Degree, Certification
Total Yrs of Experience BA/BS Degree, 0 - 2 years experience in software development and/or testing

110

QA Specialist Resume Examples & Samples

Liaise with the UK Customer Service teams to learn and implement best practice and to drive customer and performance improvements
Recommend, own and drive performance improvement areas
Drive through improvement initiatives to implementation
Assist with compiling, analyzing and driving Repeat Contact Resolution improvement initiatives
Provide a holistic view of customer performance and identify the levers which will drive improvements
Uses quality monitoring data management system to compile and track performance at site, team and individual level

111

QA Specialist Resume Examples & Samples

STLC
Automation tools knowledge (UFT/SOAPUI/POSTMAN/TOSCA)
Web Services testing/automation
Network/Protocol Testing
8 - 15 + Years in Software Development (Finance/Media)
Scripting using different languages like VB Script, Java, Java Script
Automated build systems like Maven, Jenkins
Designing Automation frameworks
ALM/Jira Integration
TestNG, Selenium

112

QA Specialist Resume Examples & Samples

QA Go-To-Market support to Starch Sweeteners AP exporting business and CTS trading products in SEA region
Handling customer complaints, filling questionnaires from customers, provide necessary technical documents to customers,including various statement, certificates, third party testing reports etc
Coordinate the technical issues between commercial team and manufacturing sites
Work with QA GTM lead, GTM specialist of other regions, production site as well as product line to build the Starch and Sweeteners business QA GTM database/sharepoint that can be used by all related departments
Assist Business FSL and GTM lead to collect GTM information, conduct data analysis, prepare monthly report and other reports whenever needed
80%
Process and manage Go-To-Market technical requests regarding quality, food safety and regulatory compliance in the region. Provide timely,sound feedback to internal and external customers
Coordinate the food safety and quality related communication & requirements among the manufacturing sites, distributor and customer for imported products from Europe, USA, China etc
Handle customer complaint for Starch and Sweeteners business and CTS traded products; focus on complaint communication, product quality issue/problem clarification, follow up on investigation and customer feedback
Collect, analysis, review and report the quality performance and customer feedback regularly
Manage the related food safety and quality documentation for traded products. Localization or translate the quality related documentation based on customer requirement; confirm the specifications, COA and solve the problem that resulted by the different regulation/requirement between export and import area
Work closely with regulatory affairs specialist on understanding the latest up to date mandatory requirements of region. Collect related documents and take lead for prodcut registration in China, provide necessary support to the staffs of other regions for the production registration in local FDA or authorities
Arrange 3rd party test of related products and provide the report to the commercial team in time
Conduct Food safety training for both internal and external customers, 3rd party contractors
Conduct external warehouse audit in the region
Conduct QA GTM training like IMPAS, use of QA GTM sharepoint etc. for the staffs whom needs to work with
Work with QA GTM lead, GTM specialists of other regions, production site as well as product line to build the business QA GTM database/sharepoint that can be used by all related departments
Prepare QA GTM reports

113

QA Specialist Resume Examples & Samples

Reports to Quality Assurance Manager
Supervises other quality specialists working with the Corrective Action Program
Works on all aspects of Corrective Action Program including non-conformances and corrective actions
Works to maintain electronic corrective action system
Provides reports associated with corrective active program progress
Works with other functional departments on working within the electronic corrective action system
Create and revise QA related procedures and documentation
Works on straightforward tasks using established procedures; work is subject to review by others
Depends on others for instruction, guidance and direction
Develops knowledge and skills in basic practices and procedures within own area
Applies basic technical skills and knowledge to complete assigned work
Responds to standard requests from internal or external customers
Works with others as part of a team
Available to work overtime and weekends when needed

114

Software QA Specialist Resume Examples & Samples

Bachelor's degree in Engineering, Physical Science, or Computer Science and minimum of 2-4 years related experience
IBM Jazz/RTC or Microsoft TFS
The successful candidate will have expertise in creating and implementing a detailed plan to ensure overall quality of all IT products, services and systems
They must have experience in resolving all project or program release problems and take corrective action, escalating as needed, to resolve and achieve results
They must also have experience in assuring the viability, functionality and effectiveness of essential tools
Knowledge and experience with the Department of Veterans Affairs VIP / ProPath Methodology (Preferred)

115

QA Specialist Resume Examples & Samples

Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a scientific discipline or four (4) years related experience in lieu of degree
No experience required with Bachelor’s degree
Must understand quality systems compliant with FDA regulations for cGMP
Must have good writing skills
Must have the ability to clearly summarize and communicate calibration issues to staff
Experience in maintaining databases and data entry
Experience in a cGMP environment
Basic knowledge of cGMP requirements as it relates to maintaining calibrated instrumentation
Experience with Blue Mountain Regulatory Asset Management database
Experience working in an environment regulated by Standard Operating Procedures (SOPs)

116

Senior QA Specialist Resume Examples & Samples

Track and report on progress of ongoing, multiple projects
Achieves quality assurance objectives by contributing information and analysis to strategic project plans and reviews; identifying and resolving problems; determining system improvements; implementing changes; navigating thru and practical implementation of quality system to newer business segment
Assures consistent quality of production by developing and enforcing good automated manufacturing practice (GAMP) systems
Process Improvement, Analyzing Information , Verbal Communication, Informing Others, Quality Engineering, Emphasizing Excellence, GAMP, Attention to Detail, Thoroughness, Dealing with Complexity
Knowledgeable in ISPE's guidelines for Good Automated Manufacturing Practice (GAMP)
Strong computer skills including MS Office and databases

117

Digital IT QA Specialist Resume Examples & Samples

Website monitoring solution management and administration
Definition of scenarios for all websites hosted in EMEA realm and monitoring of their performances
Define, document and maintain Quality criteria and best practices
Monthly KPI dashboard creation and analysis
Action plan definition and follow-up in order to improve website performances
Platform workflows monitoring (data exchange between different e-commerce layers: Demandware, OMS, SAP, CRM...)
Risk communication and mitigation in a timely manner
Maintain QA documentation keeping it accurate and complete
Account role definition and access granting for all users using digital tools such as Demandware, Jira and our different PSP providers
Strong Quality Assurance skills and wide technical knowledge
Mastering at least one monitoring solution (Catchpoint, Keynote, IP Label…)
DevOps past experience a bonus
Planning and organization skills
Communication and interpersonal skills
Demonstrated analytical, reporting and presentation skills
Organized and solution minded
Strong affinity with IT across multiple domains
Listening skills
Innovative mindset
Assertiveness
Agile methodology to define and enforce
Fluent English mandatory

118

Senior QA Specialist Resume Examples & Samples

Acting as a point of contact for general queries relating to QA
Support QPs and QA Management as required
Provide on the floor QA support to initiate, manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs
Provide on the floor QA/GMP SME expertise to assist non-QA functions with progressing major and critical compliance issues through the QMS processes
Provide on the floor QA/GMP SME expertise and mentoring to other QA(Operations) team members
Represent QA at departmental LQC's and Team Times
Actively suggest, initiate, participate and contribute to PQS process improvements initiatives and projects
Actively develop, mentor, train and enforce a site GMP culture on site
Support regulatory and customer audits of the site
Apply GMP regulations consistently. Expand compliance knowledge base and mentor others to expand on-site compliance knowledge
Utilising knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement activities within the QA
Support site QA leaders and QPs with timely and reliable information to support site PQS management, decision processes and strategy development
Engage in self-inspection of the site PQS
Identify opportunities for GMP compliance training and awareness campaigns - design, develop and deliver
Significant industry experience within a GXP environment
Previous QMS process design, implementation, management and utilisation experience
Significant experience in risk management and project management
Excellent risk based decision-making and problem solving skills
Demonstrated workload prioritisation and scheduling skills
Extensive auditing experience
Validation and / or Engineering knowledge or experience

119

QA Specialist Resume Examples & Samples

Review and approve GMP related documents (i.e. analytical/manufacturing records, stability, protocols, reports, environmental monitoring, etc.) pertaining to chemical intermediates APIs and drug products for accuracy, completeness, and compliance with UT policies, procedures, and cGMPs
Create and approve labels in support of manufacturing operations
Create, revise and approve Standard Operating Procedures and raw material specifications. Able to interpret multi-compendia references (USP/EP/JP)
Perform review and release of raw materials in support of manufacturing operations
Perform review of Solution Preparation Records
Performs batch record review and release of clinical and commercial products
Performs QA functions (lot check-in, area clearances, in process checks, batch record issuance, logbook issuance and review, AQL inspections, etc) to support manufacturing activities
Assist in deviation, OOS and CAPA review and closure
Provide applicable documentation to support all cGMP activities
Perform monthly facility internal audits
Act as Quality lead for internal and external developmental and commercial projects
Participate in regulatory inspections. (FDA, MHRA, etc) as applicable
Applied knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards
Ability to apply GMP to company specific processes and products
Excellent professional documentation skills
Ability to objectively, accurately, and thoroughly convey complex compliance issues in writing
Ability to produce a large volume of written materials independently
Experience in review of batch records, production records, process control records
Ability to interpret data in relation to a vast number of company procedures as well as current GMP/GLP requirements
Ability to interact with other departments effectively
Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures
Ability to handle confidential company data, projects, information, etc

120

Software QA Specialist Resume Examples & Samples

Work with functional business users and technical analysts to develop acceptance test/use cases to be manually tested or automated based on customer requirements and definitions
Develop & document test plans for each project/release
Through manual and automated testing, help validate the functionality of delivered code and verify that data inserts, updates, and deletes are accurate
Create automated testing scripts using approved USS QA tools
Participate in design specification reviews and technical documentation reviews
Create testing reports to communicate results to management
Perform a variety of tasks working under general supervision and reporting to Associate Director of QA

121

Senior QA Specialist Resume Examples & Samples

Review of Master Production Records and test instructions
Review of Batch Production Records and test results
Review and approval of documentation related to process validation, technology transfer, raw materials, product descriptions and specifications, shipments, labelling and traceability (lot genealogy)
Review and approval of all batch related deviations and change control and resolve planned and unplanned quality issues at CMO’s
Compilation of batch dossiers for technical release
Compilation of batch dossiers for clinical release
At least Bachelor degree, preferably in a technical or scientific discipline
Thorough knowledge of international guidelines on GMP
Experience with working with CMO’s outsourcing processes

122

QA Specialist Resume Examples & Samples

Participate in events on the manufacturing floor when they arise
Work directly with QA Operations Floor Support staff to ensure immediate QA swarming of events
Work with QA peers and MFG to determine if forward processing can continue and ensure documentation of this justification is in TrackWise
Review and approve level 1 deviations to ensure compliance to Shire procedures
Participate with investigation team to determine assignable cause and CAPA
Actively work with Manufacturing and QA peers to help reduce deviations
Participate in deviation system management to help support UPB and DS lot disposition
Support inspections and audits, as required
Accountable for meeting functional area goals and objectives as they relate to department and Shire goals

123

QA Specialist Quality Management System Resume Examples & Samples

Assure that all technical operations related to the production and analysis of pharmaceutical products comply with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH) and UCB corporate policies and procedures
(co-)develop and (co-)implement technical robust and compliant systems allowing to exploit, maintain, monitor and continuously improve operations
Minimum 4 years in a regulated pharmaceutical environment or other life science or health oriented field
Experience in Quality Assurance or internal & external auditing
Project-management skills
Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations/meetings
Ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision

124

QA Specialist, Mobile & TV Apps Resume Examples & Samples

2+ years in Quality Assurance role
Experience in cross-platform testing
Experience working in Agile team
Proficiency in TV/Mobile technologies
Proactiveness and highly disciplined approach to work

125

QA Specialist Resume Examples & Samples

Primary owner of Environmental and Finished Product microbiological programs
High School Diploma/GED or equivalent; or three to six months related experience and/or training. Or equivalent combination of education and experience
1-2 years experience working with computer programs such Excel, Outlook and PowerPoint
1-2 years experience leading and directly supervising others
Ability to obtain HACCP certification within a year of hire
Bilingual preferred but not required- Spanish & English

126

Business Analyst / QA Specialist Resume Examples & Samples

Collaborate with customers to gather, document and analyze requirements for large complex Software Systems. Utilize UML and/or other methodologies to conduct requirements analysis
Perform functional, non-functional (load/performance testing) and regression testing. Analyze/Document test results and provide management reports on test coverage
Work with the customer and management on User Acceptance Testing to validate business requirements and resolve issues
Work with the project teams to develop and document release and deployment plans
6 to 8 years of overall experience with 2 to 3 years in a customer facing Business/System analyst /QA role
Experience with requirements management tools, requirements best practices, analysis tools (including UML)
Experience with testing in various environments including ASP.NET, JAVA/J2EE environments
Experience with system integration testing, load/performance/stress testing and automated testing tools (SOAP UI, WinRunner, LoadRunner etc.)
Experience with configuration management tools such as Subversion and other document management tools such as Share Point
Excellent oral, written and communication skills to collaborate with various internal and external teams; ability to communicate requirements and design across teams

127

QA Specialist / RP Senior Specialist Resume Examples & Samples

Accountability as responsible person for pharmaceutical distribution activities in country or country cluster
Accountability for controlled drugs
Primary contact for pharmaceutical-technical questions in country or country cluster
Primary contact for local health authorities. Own relationship/communication with the local GDP Authorities, and host External and Internal inspections in Ireland
Responsible for the execution of product launches in responsible country or country cluster
Thorough detailed understanding of quality systems, GMP and GDP as expressed in EC OJ 2013/C 343/01
Minimum Bachelor’s degree in pharmacy, chemistry, biology or a related discipline
Extensive experience working in a QA role
Excellent interpersonal skills and professional skills to interact with contractors while representing Shire
Experience in handling inspections from local authorities

128

Call Center RN QA Specialist Resume Examples & Samples

Develop collaborative relationship with training and supervisors
Act as a consultant to Operations in evaluating quality issues
Assist with quality management studies through data collection, data input
Provide objective assessment of important aspects of patient care through ongoing chart review with preestablished criteria
Report all occurrences which may lead to KP Oncall liability to QI Manager and others as established by policy and procedure, and follow up as necessary
Assist in orientation and training of peers
Provide assistance with all call monitoring of staff both RN's and CSS's
Assist the Manager of Quality Improvement in achieving and maintaining departmental goals and objectives
Maintain the integrity and confidentiality of quality information and databases
Minimum five (5) years of experience in acute care nursing or call center as an RN
Experience in quality management with demonstrated knowledge of quality improvement, statistical analysis, preferred
Spanish speaking preferred

129

Senior IT QA Specialist Resume Examples & Samples

Expert knowledge with the ability to design and strategize on testing approaches for large, complex, cross functional programs. Overall accountability to plan and lead overall test environment, test strategy and test plan. Program level status reporting and issue resolution. Ensure on time delivery of QA deliverables on highly complex programs. Leads large vendor teams as well as less experienced QA leads within the application development organizations
Ability to lead other QA Analyst across the enterprise on programs and special assignments as needed. Represents the organization in solving problems. Uses best practice and industry standards. Inter-organizational and outside client contact
Advanced technical knowledge base to perform testing functions on multiple platforms. Identify opportunities and works with others to implement ways to expedite testing
Advanced ability to identify areas for Test Automation. Uses knowledge of broader systems organizes work and make decisions. Understands how changes impact work upstream and downstream. Define test process including required test activities, deliverables and test schedule. Leads on-shore and off-shore vendor partners in understanding the systems
Identify and lead process improvements across the QA organization. Promotes business effectiveness and efficiency while striving for innovation, flexibility, and integration with technology
Independently estimate and re-estimate projects. Recognize and communicate dependencies in cross functional testing as well as data to complete estimates. Facilitate discussions. Contribute to the funding and forecasting process. Train and mentor team members on forecasting protocols. Manages the flow of information included internal and external clients as well as leadership
Assist with on boarding new team members, coordinating and delivering training to team members. Develop content and other resources for training
Other projects as assigned
Bachelor’s degree in relevant field or equivalent work experience; Master’s degree preferred
8-12 years relevant experience to include 7 years experience leading testing teams, organizations or programs or Master’s degree with 6-10 years relevant experience
Understanding of software development methodology
MS project skills
Knowledge of automated test tools and/or programming languages
Ability to work a flexible schedule to accommodate business needs
Demonstrated advanced technical and analytical skills
Excellent verbal and written communication skills with the ability to adjust quickly to meet the needs of the audience
Detail oriented with the ability to work and guide others during time constraints to meet deadlines
Demonstrated ability to mentor and train teams
Knowledge of best practices and industry standards

130

Senior QA Specialist Resume Examples & Samples

Management of Documentation Control
Deviation review and approval (with Quality Manager and primary QP )
Management of Change control review and monitored to ensure closure in a timely manner
Maintenance and update of the Product Specification folders on the shared server
Following up and obtaining Product Quality Review Reports from Contractors and preparation of the same
Assist in the preparation all Quality Quarterly reports
Maintenance of retention of reference samples and batch documentation stores
Maintenance of the Master List of Products to be released ( in conjunction with the Quality Manager and QP)
Generation and maintenance of Technical Agreements with Suppliers and Customers as required (with Quality Manager and primary QP)
Approve contract packaging documentation such as Packaging Instructions/Batch Production Records as required and ensure all necessary checks have been completed with the BPR for QP Release
Ensure compliance to the conditions of the Manufacturing Licence and compliance to GMP in all activities which affect Product Quality
Ensure that all activities are in compliance with the requirements of Good Manufacturing Practice
Assist in all technical aspects and projects as and when required by the Quality Manager and the Business Unit Manager
Minimum of a level 8 degree in a relevant discipline

131

QA Specialist Resume Examples & Samples

The overall responsibility of this role is to support and execute the strategy for compliance to Good Manufacturing and Good Distribution Practices for the commercial distribution of small molecule, biologic, plasma and device products/services in North America (not including OpU activities) (e.g. distributors, transportation partners) in accordance to Shire’s global standards
In addition, this role will be responsible for supporting the evaluation of new external partners/suppliers in North America, identifying risks and implementing changes to ensure compliance to Shire’s standards
This role will be responsible for the maintenance of inspection ready facilities and operations in line with global regulatory expectations and requirements in North America
This role is responsible for the successful and timely completion of goals and objectives associated with North America expansion and launch strategy, real estate and supply chain strategy, integration of new business into North America, operations management, and implementation of Shire's license integration strategy
Responsible for establishment and continuous improvement of distribution and supply chain quality processes, driving for compliance and efficiency while allowing local flexibility
Responsible for supporting global quality processes roll out to North America and providing effective execution support of the global quality processes to North America
25% Quality oversight for all distribution aspects of commercial products including transportation, warehouse, and field related activities, contract organizations, health authorities interactions as related to GDP in North America. Drive improvement and consistency of common in scope processes, such as processes related to local licenses maintenance and overlabeling process
25% Negotiate and execute Quality Technical Agreements in the region
5% Quality operation including local field connections including falsification, returns, recalls and complaints
15% Quality input and execution of regional strategies including expansion and launch strategy, supply chain strategy, new business integration strategy
15% This role also includes support and execution of associated compliance activities (e.g. training, documentation, auditing) including implementation of additional applicable regional expectations with support from the other Quality Organizations
15% Support enhancement and maintenance of Quality Systems and processes that supports manufacture and distribution of Shire Products in the North America
Minimum of a Bachelors Degree in technical discipline such as biochemistry, chemistry, engineering
Advanced degree in complimentary field of study a plus
At least 5 years of experience in the biotechnology and/or pharmaceutical industry, preferably both
Experience with small and large molecule production processes, aseptic processing, as well as tableting and controlled substances is desired
Over sight of CMO and CTL operations
Packaging and labelling
Distribution
Strong operations background to ensure value added and effective quality operations
Experience driving out inefficiencies and improving turnaround times
Understands regulations pertaining to licensing, import/export, scheduled/controlled drugs, and transportation requirements, in North America
Working in a multinational organization effectively navigating differing regional expectations and regulations

132

QA Specialist Resume Examples & Samples

Provides support to the QA department with incoming material inspection as per GMP requirements
Conducts pre, in process and post line clearances as per GMP requirements during the Packaging and Labelling of Clinical Supplies
Reviews batch records and other GMP documentation
Keeping computer records up to date
Scanning, photocopying, paper filing as required
Working in a small specialised team
Provides training for QA staff where required
Assists with audits or activities in area of expertise and client / regulatory inspections/audits and follows up on audit issues and corrective action
Participates in inter-departmental meetings
Evaluates acceptability of data based on criteria set forth in SOPs and methods
Bachelors degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree
Previous QA experience that provides the knowledge, skills, and abilities to perform the job
Proficiency in Microsoft Office programs (Word, Excel, PowerPoint)
Excellent communication and organisational skills
Ability to handle multiple tasks and deadlines
Must be self-motivated and possess a positive attitude and maturity
Ability to juggle multiple tasks whilst still delivering high quality results
Detail oriented and able to prioritise efficiently
Possess the maturity to handle sensitive and confidential information appropriately
Knowledge of pharmaceutical cGMP regulations
Basic understanding of Quality Assurance programs, practices and regulations
Strong problem solving and impact analysis abilities

133

QA Specialist Resume Examples & Samples

Assist with the implementing quality management system and ensure compliance on every stage of the operations
Ensure all local process and practices are following the Corporate Standard and develop local process as required
Conduct gap assessments and provide implementation action plan
Assist in the documentation of corrective actions plans and monitors implementation
Prepare and reviews quality documentation
Gathers data and documents for audits and inspection
Ensure complaints handling, adverse event reporting and field actions are implemented in time and in accordance with procedure
Self-motivated, mature, pleasant personality
Work independently and willing to take challenges with minimum supervision
Good communication, presentation and interpersonal skillsSelling MD&D

134

Senior QA Specialist Resume Examples & Samples

Responsiblefor implementation of risk management/risk based validation for Singapore and deliver functions consistent with the risk management corporate program
Provide leadership/facilitation on complex/high level risk processes
Serve as the Quality Risk Management representative on cross-functional and multi-site teams
Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address unusually complex problems
Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships
Serve as a technical subject matter expert (SME) on Quality systems, processes, and issues in support of departmental functions
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Make decisions that impact the goals and objectives of the organization, and also make recommendations regarding best options to influence decisions
Set personal performance goals and collaborate with management to establish organizational objectives
Prioritize workload to meet department and organizational targets and timelines
Manage competing priorities and maintain accountability for deliverables affecting department and organizational objectives
Manage department and cross-functional initiatives
Sign documents for activities as authorized and described by Company policies, procedures and job descriptions
May provide guidance and manage work activities of other staff members for specific projects or objectives
As part of Quality Systems, support the Site Inspection Management (SIM) lead for the site for Health Authorities, Corporate audit and partner audit

135

Senior QA Specialist Resume Examples & Samples

Reviews release data, prepares appropriate release documentation and executes release of vendor raw materials
Manages QA requirements of SCAR process i.e. initiation, review, monitoring
Support Supplier Quality Group as needed
Support Materials Management Group as needed
Initiates, edits, review and approves change control and SOPs
Provide training as required within the QA Raw Materials Group
Performs compliance monitoring of area operations and notifies area and Quality Management of any observed non-compliance
Requires BS/BA in scientific discipline or related field plus minimum 6 years of relevant experience. May consider significant industry experience in lieu of educational requirement
Minimum 2 years supervisory experience preferable

136

QA Specialist Resume Examples & Samples

Test legacy and new test cases with the use of formal test cases or scripts
Execute smoke, regression and functional tests
Interpret test cases, compare them to established specifications
Ability to go beyond the specification and anticipate problem areas in the product design and document test cases results and compare to expected results
Ability to follow instructions and pre-established guidelines to perform the functions of the job

137

Tech Editor / QA Specialist Resume Examples & Samples

Review written and web-based instructional materials to ensure proper grammar, spelling, writing style, terminology, and formatting
Review web-based training products to ensure intended functionality, proper navigation, layout, usability, and conformance with other quality standards
Verify resolution of errors prior to final delivery
Ensure consistency and quality standards across project deliverables
Create and/or maintain internal Style Guide and client-specific Style Guides
Design templates for written materials in accordance with branding and existing style requirements
Recommend improvements for quality review cycles to increase efficiency and quality
Compile and maintain database of quality issues to lead to continuous improvement efforts
Conduct compatibility testing for web-based products (browsers, mobile devices, tablets)
Conduct SCORM testing on Learning Management System
Conduct accessibility testing (e.g. JAWS)
Participate and/or lead meetings with Instructional Designers and other team members to review materials, resolve quality issues, and determine collaborative resolutions to reduce future errors
Prior experience with the Air Force Education and Training Command (AETC)
Familiarity with other U.S. Department of Defense organization’s instructional training and education concepts, processes, and development models

138

QA Specialist Resume Examples & Samples

Planning, execution, and documentation of the qualification and monitoring for third party suppliers who are delivering excipients, raw or packaging materials, to the Supply Chain for the manufacture of Intermediates, APIs, or drug products respectively
Surveillance on the quality and compliance status for all third party supplied raw materials, packaging materials, intermediates, excipients, and APIs
Performing audits at suppliers
Management of Change in Trackwise (change assessor, action executioner , quality approver of supplier notifications)
Assessment of deviations, corrective and preventative actions (CAPAs), and complaints concerning suppliers
Establishment and periodic review of Quality Agreements
Establishment and revision of Qualification Statements, quarterly performance metrics, and annual qualification classification for suppliers
Support API manufacturers during health authority inspections
Initial assessment and qualification of suppliers for new product introductions
Support internal site Regulatory inspections

139

QA Specialist Resume Examples & Samples

35% Batch documentation review and release activities per Shire quality systems
To provide QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with GMP and regulatory requirements
To be knowledgeable about the products supplied for clinical trials
Ensure that all required batch documentation is obtained from contractor manufacturer/suppliers to enable the release of product
5% To effective liaise with contractor manufacturers/suppliers regarding technical information and queries
High level of professional competence. Preferably demonstrated by objective certification (e.g. Certified Quality Auditor or Engineer)

140

Software QA Specialist Resume Examples & Samples

Demonstrated on the job experience planning, developing, and executing test strategies in Agile environments
Demonstrated on the job experience developing and conducting systems tests to evaluate customer requirement compliance
Demonstrated on the job experience in an Agile environment supporting methodologies such as Test Driven Development, continuous integration processes, rapid or iterative development
Demonstrated on the job experience using configuration management tools for documenting test cases, test results, and other program pertinent information
Demonstrated on the job experience with automated testing tools (for example, Selenium)
Typically requires bachelor’s degree or equivalent and five to seven years of related experience
This position requires an active TS/SCI with Full Scope Polygraph
Demonstrated on the job experience with executing test automation scripts in Continuous Integration tools such as Jenkins / Hudson
Demonstrated on the job experience with web technologies or basic use of SQL or Database Query tools to execute repeatable test cases
Demonstrated on the job experience working independently or as part of a team, meeting deadlines, achieving results, and adjusting quickly to alternating priorities
Demonstrated on the job experience researching, advising, and implementing industry best practices and benchmarks

141

QA Specialist Distribution Resume Examples & Samples

Maintain Quality system to support EPD Supply Chain and Distribution at APO AG site, including GDP Training, internal audit program, document control, Quality manual
Supervise Returns
Record, lead Distribution complaints and discrepancies (Root Cause Analysis, CAPA)
Provide GDP support to the EPD Regions
Select and Approve Logistics/Transport Service Providers (LSP/TSP)Third Party Warehouse (TPW) for EPD Supply Chain and maintain Approved Supplier List
Establish and maintain Approved Customer List
Participate in Distribution projects, provide QA compliance
Work in close collaboration with Supply chain, Global Distribution, Master Data, Global QA Supplier, Global Product Protection, in order to deliver inputs in compliance with GxP requirements
Minimum 3 years combined experience in QA and/or Operations/Technical function in Pharmaceutical environment
Familiarity with GMP/GDP regulations in multiple countries
Project management expertise
Perceptual and analytical problem solving related to removal of obstacles, setting priorities, people, resources and facilities involvement
Ability to communicate effectively, both orally and in writing to both internal and external audience
Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives

142

QA Specialist Resume Examples & Samples

Responsible for the review and approval of laboratory testing methods, raw material specifications, and standard operating procedures
Responsible for generation, inspection and release of labels
Responsible for release/rejection of raw materials
Responsible for generating quality data and reports
Responsible for compliance auditing of both internal and external sites
Assists in identifying and implementing process improvement opportunities to existing systems
Acts as a resource to other departments regarding the implementation of the Quality System
Responsible for training/mentoring new hires and transfers within the department
Responsible for authoring reports and SOPs as needed
Responsible for maintaining the company’s controlled documents in accordance with cGMP requirements
Responsible for Supplier Qualification Program, and Change Control System

143

Software QA Specialist, Associate Resume Examples & Samples

Maintaining policy and procedure documents
Previous experience working on a government contract
Ability to adjust to shifting priorities
04-05 years w/High School Diploma

144

QA Specialist Resume Examples & Samples

Routine Document Review
Assist with QA Event Response
Assure GDP (Good Distribution Practices) in a warehouse environment

145

Software QA Specialist Resume Examples & Samples

B.S. or higher degree in Computer Scinece or other techical field with a minimum 5 years of experience performing analysis and testing through a full system development life cycle
Experience with SDLC models such as RUP, RAD, iterative and Agile methodologies
Experience with data retrieval methods to test database systems developed in technologies such as SQL Server and Oracle
Experience testing web-based systems developed in technologies such as DotNet, Coldfusion, and Java
Excellent interpersonal and problem-solving skills to ensure issues are handled in a fair, consistent manner
Excellent written skills to effectively communicate information to project team members
Ability to work independently, and as a team player, while using discretion indecision making and sound judgment in problem solving
Ability to create and perfomr both manual and automated tests as well as familiarity with both methodologies
Ability to perfomr defect reporting and tracking and use defect tracking tools
Ability to lead all test related meetintgs with all levels of staff
Excellent analystical, planning, and software development lifecycle skills
Excellent computer related and developmental skills, with the ability to learn new software

146

QA Specialist, GMP QA-temporary Assignment Resume Examples & Samples

Review and approve contractor manufacturing, packaging, and analytical records and data to ensure completeness and consistency with company policies and procedures necessary for batch release of clinical and commercial intermediates, API and drug products
Review and approve labeling and packaging specifications, master records, and change control
Review contractor investigations, deviations, complaints and initiate necessary records according to company procedures
Report quality metrics to QA Management for review
Maintains databases and systems used for tracking various GMP manufacturing associated support activities
Support Regulatory Authority inspections and internal & external audits
BA/BS with Biology/Chemistry focus or equivalent industry experience
Experience with MasterControl preferred
Strong collaboration and written /verbal communications skills

147

QA Specialist Resume Examples & Samples

10+ years of successful work experience as a Sr.Test Lead/Test manager (Test automation skills beneficial)
Good business understanding, information analysis, problem solving, coordination, strategic planning, and quality management
Ability to interface with stakeholders and client delivery teams, supporting the design and delivery of initiatives
Experience managing client facing projects to successful completion
Ability to interface with stakeholders and IT delivery teams, supporting the design and delivery of initiatives
Excellent presentation, meeting facilitation, and negotiation skills to all levels of the organization
Self starter with proven ability to work independently and as a team member
Good communication written and oral and interpersonal skills
Good organizational, multi-tasking, and time management skills
High energy, personable, a sense of urgency and can do attitude
Proficient in the use of Word, Excel, PowerPoint, MS Project, Visio, and Outlook
Experience in Web service Testing
Microsoft Office suite, MS Project required
Experience in Selenium ,JIRA ,HP ALM (formally Quality Center) experience a plus
Experience in working with Agile development team
Experience in Test plan, Test Estimations and Test Strategy
Expert in Business requirements understanding
Expert in Sprint Planning
Expert in Design review & Task planning
Experience in Project Metrics - Weekly & Monthly Status Report Deliverables
Experience in Functional, Regression, integration, SIT, user acceptance testing
Provide strategic direction for testing activities/initiatives
Advise customer on industry standards and practices in the area of testing
Evaluate testing products and develop proofs of concepts for new, innovative solutions
Provide test expertise in the development of test processes, standards and guidelines for the unit
Responsible for the creation of the Test Strategy and Test Approach deliverables
Identification and replication of testing best practices
Define, develop and build reusable testing assets
Provide testing SME support across area(s) of responsibility
Provide input to estimating models and refine factors as necessary. Facilitate appropriate use of standard estimation model(s)
Responsible for development of test estimates within area(s) of responsibility
Works with other project team Architects, delivery managers, and Project Managers to ensure consistency in estimating and understanding of requirements
Manage data load and scheduling for testing usage
Provide input to the test environment plan
Ensure correct use of automated testing tools as appropriate
Provide input and guidance to the in the development of the test data approach as appropriate
Identify and initiate continuous improvement opportunities in the testing area
Plan and support integrated testing of all applications within and across domains as defined by the project test plan to ensure business process flow is adequately supported
Conduct test quality assurance reviews for large/complex projects
Support the planning and preparation for UAT
Develop short-term and long-term planning to maintain alignment with the client's current and future needs
Communicate and work with client personnel as necessary
Manage key vendor relationships
Build strong customer relationships

148

QA Specialist Resume Examples & Samples

This position is responsible for the quality aspects associated with the quality systems for assigned areas: Audit, Documentation (including annual review of QAS documents), Change Control, Deviation Management, Product Release, and Product Inspection
Review and approve Production documentation and records. Ensure products meet specification requirements in master file, outline of production, and special outline for release to market (internal and external)
Collaborate with Production teams to improve the overall quality of completed documentation through training, coaching, document revisions, etc. Actively participate in assigned value stream meetings
Facilitate and perform disposition and release activities
Responsible for release of bulk, final product, Oracle transaction and entering OTIF chart and IO KPI chart for assigned area and support other areas as needed
Participate in internal audits and self-inspection (process, facility and documentation)
Quality Expert for Event/CAPA for assigned area. Review, participate and approve deviations, investigations and CAPAs
Support timely closure of change controls, deviations and CAPAs
Assist production teams with quality aspects, participation and observation of activities in the area of responsibility to ensure processes are compliant with master file, outline of production, special outline, USDA regulations and other internal standards or directives
Author and revise quality documents, and assist other departments as needed
Develop, maintain and improve department key performance indicators
Participate on various project teams (i.e. Hoshin, technical teams)
Support QA Roadmap projects
Demonstrate a visible & tangible commitment to HSE, Lean Principles, and the Merial Values in all work related activities
In addition to the above, other assigned duties & projects deemed appropriate within the position scope
Minimum 3 years’ experience in Quality Assurance, Quality Control or Manufacturing in a regulated industry
Knowledge of lean manufacturing, risk analysis and six sigma
Experience in working in a clean room operation/environment
Familiar with USDA 9 CFR and/or cGMP Regulatory requirements
Proficiency in MS Office applications (i.e. Outlook, Visio, Access, Project)

149

Senior QA Specialist Resume Examples & Samples

Relevant quality assurance experience (comparable to 10+ years) including expertise in GxP regulations (specifically Pharmacovigilance) gained from time served in a pharmaceutical, biotechnology and/or medical device industry
Experience of working in or supporting Pharmacovigilance and/or Medical Communications preferred
Expertise in all aspects of pharmaceutical GxP regulations (e.g. quality systems, root cause analysis and Total Quality Management)
Knowledge of all GxP regulations including international regulations
Knowledge of applicable parts of 21 CFR regulations
May require knowledge of ISO standards where applicable
Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented
Proactive approach to core competencies of the role

150

QA Specialist Resume Examples & Samples

Review and approve master batch records, labels, specifications and other pre-production documents for clinical APIs in compliance with FDA and international health agency requirements
Review executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any deviation and investigation reports related to lot release of clinical APIs in support of product disposition
Conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations
Assist in compliance audits as required
Review and approve stability protocols and reports
Maintain electronic records (IQS) and paper archives (lot history records, reports, and logbooks) as needed
Write, revise, and review standard operating procedures
Interact with contract manufacturers and internal Manufacturing to resolve quality issues with minimal supervision
Good working knowledge of Quality Systems and cGMP standards applicable to clinical development
Ability to work on complex issues where analysis requires an in-depth assessment, consideration of many variables, and potential consequences
Ability to lead a project team
Ability to act as a mentor to junior staff
An accountable team player who is detail and quality oriented with advanced understanding of quality assurance principles, systems, and procedures
Excellent attitude with strong verbal, written, and interpersonal communication skills
Self starter, able to work independently
Able to travel infrequently (less than 5%)

151

Senior QA Specialist Resume Examples & Samples

Prepare the annual audit plans and carry out internal and external quality audits to ensure compliance with ISO 13485, ISO 9001, FDA 21 CFR 820 and the European IVD Directive
To organize and host customer audits
To ensure that product quality is maintained throughout the manufacturing process by quality audit / assessment and implementation of recommended quality improvements
To ensure that supplier quality is maintained through quality assessment and implementation of recommended quality improvements
To investigate Quality Notifications (Customer complaints)
To load product formulations and SOPs onto SAP as and when required
Training Co-ordinator for MasterControl – Electronic Document Management system
Enable collaborative relationships between internal stakeholder departments and Quality with the overall focus of improving customer satisfaction
Work closely with Operations, R & D, Purchasing and Engineering to improve quality while reducing material scrap and costs
Assure that Basingstoke site standards comply with division policies, national and international codes, and applicable safety requirements
Bachelor’s degree required in science discipline or related field
A minimum of 2 years experience in QA
Experience in auditing practices and principles; formal auditor training desirable
Knowledge of qualification / validation (process, sterilization, cleaning, software) requirements
Willingness to travel within the UK and abroad to undertake quality audits and assessments
Experience in supervising or leading small teams to a successful outcome is desired
Medical device, GMP, EU Regulation or ISO 13485 background
Minimum of 3 years experience with administering quality systems such as change control, CAPA, training, etc
Strong leadership skills with the ability to challenge, influence, and build consensus

152

QA Specialist Resume Examples & Samples

Responsible for the customer complaint handling process, including logging complaints and performing and writing investigations
Responsible for the initial QA review of a customer complaint and requesting initial follow up information/facts from Customer/Technical Services or the Distributor as required
Responsible for monitoring the progress of complaint handling and investigation, and working with applicable individuals and departments to ensure complaint handling time requirements are met
Responsible for tracking and trending complaints and preparing complaint analysis reports, highlighting any adverse trends
Responsible for highlighting any potential reportable events to QA/RA Management as soon as possible as per the Medical Device Reporting/Vigilance procedures
Responsible for the CAPA process, ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy
Responsible for coordinating and capturing records of the Material Review Board, Quality Review Board, CAPA Review Board and other such reviews pertaining to the CAPA system
Responsible for establishing and maintaining training materials for effective nonconformance handling, root cause analysis, CAPA handling; complaint handling and delivering such training to users of the applicable process
Responsible for monitoring the progress of nonconformance investigation and each stage of the CAPA process e.g. CAPA determination & approval, CAPA implementation and CAPA effectiveness checks; capturing and reporting metrics and highlighting to management when CAPA processing target times are not being met
Responsible for preparing & presenting data/reports regarding CAPA metrics (e.g. cycle times, number open, % effectiveness) for submission to Site, Divisional and Corporate Management Review
Responsible for planning & performing nonconformance investigations when required
Responsible for planning & performing effectiveness checks on CAPA when required
Responsible for contributing to the continual quality & reliability improvement of APD products and services
Ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy
Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management
Associates Degree required, with Bachelor’s Degree a strong preference
Minimum 2 years of experience working within a QA/RA department
Experience of working with FDA regulated products (Medical Device/IVD preferred) (pharmaceutical or dietary supplement experience is acceptable)
Knowledge of ISO13485 / FDA QSR Part 820 / 803 requirements preferred,
Experience working with complaint handling and/or CAPA & management review
Ability to work in a timeline driven environment
Excellent communication skills both written & oral
Less than 5% travel (US, European & International)

153

Principal ESH / QA Specialist Resume Examples & Samples

Identification and evaluation of ES&H related risks,
Formulation of standards compliant strategies that are consistent with NST staff and users programmatic research objectives,
Assistance in the implementation of hazard controls, and
Review of user proposals to determine whether work falls within NST policies and procedures regarding ES&H. Holds the role of Quality Assurance Representative
Professional discipline of ES&H and with DOE safety standards
Project, team and management skills and the ability to work with a diverse internal and external workforce and to achieve compliance within all aspects of ES&H
Knowledge of hazards found in and effective control measures for chemical laboratory operations
Knowledge and experience in the physical sciences, scientific equipment, and chemistry laboratory operations
Experience in working within a scientific environment with unique, high tech instruments and equipment
Team abilities and the skill to prioritize, set objectives and achieve compliance
Ability to keep current of emergent technologies, best practices and lessons learned and communicate to management, staff, and users
Applied knowledge of human relations and behavior
User knowledge about and experience with personal computers, associated software, the internet and information management systems
Professional oral and written communication skills
Knowledge of Argonne and DOE safety requirements highly desirable

154

Clinical QA Specialist Resume Examples & Samples

Perform vendor qualifications and ensure quality oversight of vendors throughout term of service
Plans and leads GCP audits of clinical sites, vendors and trial master files to ensure compliance to the Code of Federal Regulations, ICH, applicable regulations and company SOPs
Responsible for initiating and managing corrective action plans for the department
Reviews and identifies gaps in department SOPs
Performs a quality review of clinical documents including but not limited to protocols, clinical study reports and investigator brochures
Ensures compliance of clinical development activities with GCP, ICH guidelines, federal and international regulations and Depomed SOPs
Assists in investigative site preparation for regulatory agency visits
Provides training to the Clinical Affairs team members in GCP and ICH guidelines
Performs internal audits of the Clinical Affairs department
Bachelor's degree preferably in a science or healthcare field
A minimum of 3-5 years of direct experience in GCP QA activities
Extensive knowledge of GCP, ICH guidelines and federal regulations as it relates to clinical research
Demonstrated computer skills (e.g. MS Office, MS Project, and MS PowerPoint)
Organized, detail-oriented and able to work independently with minimum supervision but also work collaboratively
Sense of urgency in completing assigned tasks
Willing and able to learn new skills to meet changing needs of the organization
Effective process and project management skills
Knowledge of clinical study conduct

155

QA Specialist Resume Examples & Samples

Implement the Cargill FSSC22000/ISO 9000/HACCP and others committed system in site; attend HACCP yearly review
Optimize the QA/food safety system, update/review related procedure and document to meet regulation/law/government/Cargill/customer requirement
Implement monthly, daily food safety / quality audit, and trace the corrective action that be highlighted during audit are in place in time, drive for/conduct the validation activities for corrective action with related department As coordinator of apply for the certification of FSSC22000/Halal/ISO/HACCP/IP and others will be implemented in the future
Support for SC certificate application,FDA audits ,CIQ and customer audit activity in site
Suppot for maitain government communication and relationship
Finished customer questionnaire and feedback other query from customer
Support for deal with the customer complaint
Conduct the GLP and quality control system in site like chemical control/record & COA management/equipment management & maintain &calibration/retention sample management etc,
Implement finished goods release,and responsible for check and ensure delivery document
Suppot for inspection/testing plan/ /sampling plan/environment monitor plan setting and ensure implementation; Cordinate the ring test with 3rd party and sister unit lab
Review analysis data and trace for deviation investigation
Support for analysis method development
Trace for deal with nonconforming and return goods
Attend relation training on time
Maintain good relationship with internal cooperated departments
> 3 years work experience on food safety and quality system management
Country and local regulations on analysis measurements of food products
Good skill with understanding of standard and regulatory

156

QA Specialist Resume Examples & Samples

Education: Associates Degree or Bachelors Degree in Nursing
Experience: 3-5 years as an RN in Acute Care setting
Licensure: RN
Skills and Abilities: None

157

DPS QA Specialist Resume Examples & Samples

Take corrective action, subject to the client Management approval, to resolve all issues and problems encountered with testing to ensure the applications perform as required
Ability to collaborate with supporting resources across business and/or functional lines
Have excellent organizational skills, proven analytical, planning, problem solving, and decision-making skills
Certifications in Software Testing Field
Certifications in Microsoft tools and technologies

158

Nestle Philippines, QA Specialist Resume Examples & Samples

Ensures the regulatory compliance of the product is monitored, controlled and achieved
Ensures that consumer complaints are properly evaluated and acted upon to prevent re-occurrence
Implement system resulting to safe and consistent product
Strong training skills
Able to write procedures and guidelines in simple terms
Key principles of NQMS, elements and implementation
Use of Microsoft Powerpoint, Word etc
Allergen Management
GLOBe/SAP QM
Graduate of Food Technology, Food Science, Chemistry; or Chemical Engineering or other related courses
With at least 3 years minimum experience in Quality Assurance Department

159

QA Specialist / RP Senior Specialist Resume Examples & Samples

Accountability as responsible person for pharmaceutical distribution activities
Responsible for the execution of product launches in Ireland
Support wholesaling activities for Shire Products covered by SPIL WDA
Ensuring the conditions of the Wholesale Distribution Authorisation are maintained
Ensuring that the operations do not compromise the quality of medicines by ensuring that systems are in place to monitor storage of the product through the supply chain under the control of the company
Ensuring there is an adequate quality system in place and that it is maintained in compliance with GDP requirements
To write, review and approve SOPs as required
Reviewing and advising upon the company’s standard operating procedures in relation to the operation of the license
Overseeing audit of the quality system on a regular basis, tracking and assisting in the closure of Internal and External Audits
Implementation, execution and administration of CAPA’s as required
Ensure that accurate records, as required by the individual elements of the QMS, are kept and maintained in a secure manner
Be involved in, and ensure that, customers and suppliers are approved
Ensure that there is a system in place for handling customer complaints efficiently and effectively
Assist the Supply Chain Organisation to ensure continuity of supply is maintained
Ensure that there is a system in place for handling of returned goods
The RP shall be involved, as required, in communications with the HPRA with respect to activities as they apply to the Wholesale Distribution Authorisation
The Responsible Person shall be contactable at all times and shall provide the HPRA with the appropriate contact details
On taking on these responsibilities, the RP shall ensure they have sufficient knowledge on the products distributed and on the detail of the operation. The RP shall keep themselves up to date with any changes in the legislation and with on-going training as identified
Ensuring that the required training programs are in place
To be involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified product
Participate in recall decision and support product recalls as required under the WDA. Ensuring adequate supervision of any product recall system implemented
Ensuring that a procedure is in place to handle suspected falsified medicinal products
Advising on Good Distribution Practice, outlining where the company may not be following Good Distribution Practice and providing recommendations to ensure compliance with Good Distribution Practice
Where contract organizations are used, responsible for review and approval of the Quality Agreement and ensuring that contractors are performing as required by the agreement
Support of projects within LOC QA, including launch/expansion in country
Is accountable for all quality KPIs for the country or country cluster as required
As an active member of Global QA Community, contribute to develop and strengthen global quality management systems, and provide flexible support to business both at the country level and global level
Providing any other duties or giving such other advice properly associated with the duties of a Responsible Person under the terms of the License and Guidelines on Good Distribution Practice for medicinal product for human use (2013/C 343/01)
Support ongoing integration projects at Shire associated with Distribution and Supply
Support to Quality Lead and other RPs within the cluster
Qualification as responsible person for GDP (as applicable and required by country regulations)
Bachelor’s Degree in scientific discipline
Practical experience of at least 5 years in the Pharmaceutical Industry, a majority of which has been gained in a QM / QA environment. Supply Chain knowledge is beneficial
Excellent knowledge of local GDP and Controlled Substances regulations, plus good awareness of other GMP\GDP requirements e.g. ICH, FDA

160

QA Specialist Resume Examples & Samples

Liaise with the Global Customer Service teams to learn and implement best practice and to drive customer and performance improvements
Assist with compiling, analyzing and driving First Contact Resolution improvement initiatives
Provide the NA operation with a holistic view of customer performance and identify the levers which will drive improvements
Assist in the development of robust quality improvement coaching and training processes to drive continuous improvement
Implement and own action plans which driver performance improvements
Create growth plans linked to performance improvements and drive through the associated benefits
Uses quality monitoring data management system to compile and track performance at team and individual level
NQF L4 or equivalent qualification
Proven background of quality related analysis, with ability to draw conclusions and recommend improvement initiatives
Advanced Excel Skills
Word, HTML or other technical skills are advantageous
Ability to communicate both written and orally to all levels of management and across various cultural backgrounds
Fluent English language skills (spoken, reading and written)
Additional European languages are desirable

161

QA Specialist Resume Examples & Samples

Adhere to and ensure compliance with company policies and procedures related to manufacturing and packaging
Serve as a direct, on-site contact for manufacturing personnel
Inspect production equipment for cleanliness to ensure it is prepared for future use
Perform QA functions (batch check-in, line clearance, in-process checks, etc) for manufacturing activities
Assist with deviation, containment, and CAPA processes for atypical manufacturing/packaging events under direction of QA Management
Participate in documentation management processes to include SOPs, APRs, batch records, protocols, and complaints as appropriate
Compile manufacturing data for drug products
Assist in product complaint investigations as applicable
Process rejected lots and product identified for destruction
Process retention samples
Review records (pest control, environmental monitoring, etc) as needed
Perform other duties as directed by manager
Proficient in Microsoft Office Word, Excel, and Outlook
Prior experience working in solid dose/tablets, sterile fill, and packaging preferred
Working knowledge of U.S., FDA, EU and JP GMP regulations
Must be detail oriented, self-motivated, organized and have the ability to prioritize work
Must be able to work independently and as part of a multi-functional team, able to handle high workloads, stressful situation and deadlines
Must be able to lift and carry up to 5-10 pounds throughout the day and on a regular basis
Must be able to stand and be mobile for long periods of time (production based environment)

162

QA Specialist Resume Examples & Samples

Phones experience (Member Support or preferably Payment Solutions & Payment Processing)
Ability to effectively communicate verbally and in writing
Superb attention to detail
6+ months of experience with Lending Club operations
Willingness to learn new proficiencies in other departments

163

QA Specialist Resume Examples & Samples

Functions as a quality assurance representative for the Deviation, Out of Specifications (OOS), and Trackwise® systems
Exercise independent judgment utilizing generally defined practices and policies to make sound, logical decisions and propose effective solutions to complex problems
3-10 years in QA/QC/Compliance in an FDA/DEA regulated environment or a minimum of 3 years in API manufacturing in an FDA/DEA regulated environment
Ability to exercise sound discretionary judgment, prioritize multiple competing tasks, and work with minimal supervision
Ability to communicate effectively with all departments
A basic understanding of Microsoft Office products
Familiarity 5S/lean manufacturing concepts
Familiar with Trackwise for exception reporting

164

QA Specialist Resume Examples & Samples

· Lead / supervise all aspects of Quality excellence with emphasis on continuing to improve operating results and strengthening underlying processes
· Providing Operational floor management by monitoring service levels, making appropriate decisions and regular monitoring of quality
· Regular Client interfacing for feedback and Quality updates
· 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
· Coaching, mentoring and training the team

165

QA Specialist Resume Examples & Samples

Must be 12 months in the current role,band and account
Good KPI standing for the last 6 months Must not be currently enrolled in aPerformance Improvement Plan (PIP)
Must not have incurred any disciplinary action / Remedial Action Plan (RAP)for the past 12 months (reckoning period will be the date employee received theNotice of Resolution)
Note: Written warning for WPS cases are excluded

166

Senior QA Specialist Resume Examples & Samples

Maintains a current awareness of EPA, FDA, and OECD Good Laboratory Practice (GLP) regulations and any other related Regulations which may apply to XBL activities
Other duties as assigned by QA management
Computer skills: working knowledge of Internet, MS Word, Excel, Outlook, SharePoint and PowerPoint

167

QA Specialist Resume Examples & Samples

Supporting the overall KPIs for QA Operations
Managing the establishment of processes and procedures
Supporting the overall KPI's for QA Operations
4 – 5 years of experience from a regulated company, or similar experience
Minimum 2 – 3 years of experience of handling NCR and Deviations
Knowledge of rules and regulations for Medical devices and/or In Vitro Diagnostic products
Extended knowledge of the rules and requirements in the non-conformance reporting process
Strong knowledge of quality systems
Proficient in English language, written and verbal

168

QA Specialist Resume Examples & Samples

Lead/supervise all aspects of Quality excellence with emphasis on continuing to improve operating results and strengthening underlying processes
1 year experience as a QA in a sales support environment
Experience with a travel account is a plus

169

Mobile QA Specialist Resume Examples & Samples

Bachelor’s Degree in Computer Science, Engineering, Math or related discipline
Extensive experience with blackbox testing
Proficiency with JIRA or other bug/project tracking software
Strong verbal and written communication skills with the ability to express complex ideas designs and issues to both technical and non-technical staff

170

Glp QA Specialist Resume Examples & Samples

Provide QA support to Preclinical Development in Verona
Review and sign GLP protocols and review amendments
Conduct GLP data and report audits and prepare and sign QA statements
Conduct and follow up GLP critical phase inspections
Conduct process, facility and system inspections
Maintain and archive QA files
Review and approve Standard Operating Procedures
Author of QA SOPs
Provide support during Client audits and Regulatory Authority inspections and follow up of corrective actions as required
Provide regulatory support to the business
Interact with business departments for the assessment and implementation of new procedures and processes
Identify problems and issues and have a proactive approach to resolving them
Degree in Biology, Biotechnology, Pharmaceutical Technology and Chemistry, Chemistry, or equivalent
A good understanding of the Quality management process preferentially in GLP areas
Good planning and organizational skill, team work, customers focus, proactivity
2 years of experience in a similar role

171

Cscn QA Specialist DCS Resume Examples & Samples

2+ years’ experience as a business or operations analyst with an emphasis on customer service, product management, or business strategy
Has 2 year proven analytical experience with data mining and reporting
Excel skills (intermediate to advanced proficiency)
Very good English communication skill on both writing and speaking
Goof soft skill on communication with strong business sense
Degree in mathematics, statistics, computer science, engineering, economics or related analytical field
SPSS, SAS, R or other statistical software packages
SQL or comparable data querying packages
Six Sigma Green Belt or Above

172

GCP Clinical QA Specialist Resume Examples & Samples

Review clinical protocols and informed consent documents for compliance with ICH and FDA GCP requirements and USAMRIID SOPs
Audit clinical study records, clinical database reports, processes, facilities, Office of Human Use and Ethics for compliance with protocols, study specific procedures, FDA GCPs, ICH Guidelines, SOPs and Army Regulations
Audit training records to assess compliance training needs
Using proper English grammar and syntax and Microsoft Word, write reports of audits no later than two weeks after audit completion and circulate these reports to appropriate individuals IAW USAMRIID SOPs
Maintain and update required supporting quality assurance documentation
Prepare and sign Audit Certificates
Provide GCP and compliance related training as needed
Maintain an SOP-compliant training record
Review and format SOPs as needed
Distribute SOPs to users
Consult with staff in matters of FDA GCP and ICH compliance
Write SOPs as needed using proper English grammar, syntax and SOP-required format
Attend meetings, representing QARCO, and keeping QARCO informed of meeting content
Be certified by the Society of Quality Assurance as a Registered Quality Assurance Professional in GCP (RQAP-GCP), or possess a thorough knowledge of FDA GCPs and the ICH Clinical Trial guidelines as well as the application of GCPs in regulated clinical research
Be conversant in medical terminology
Communicate effectively and professionally via written and vocal means with a community of personnel with varying levels of education
Be able to negotiate with customers on matters of compliance
Foster positive working relationships with the audited community
Be computer literate, having a comfortable facility with the Microsoft Office Suite, including Word, Excel, PowerPoint and Outlook
Stay abreast of current industry standards in GCP compliance and regulatory expectations through continuing education
Additional knowledge, skills and abilities in FDA Regulatory Affairs, International Standards Organization, GMP, GCP, Army Regulations, and other compliance areas is preferable
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Contractor employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the TOCOR immediately
Performs light duties and other related duties as required and assigned
Bachelor’s degree in science related field
3 years in GCP QA, or 3 years of hands-on experience performing GCP regulated research required
LPN, or RN, or BSN in MD preferred
Credentials, optional but ideal

173

Clinical QA Specialist Resume Examples & Samples

Batch documentation review and release activities per Shire quality systems of clinical trial material produced and released by Contract Manufacturing Organizations (CMOs)
Bachelor’s degree in chemistry, biology, pharmacy or a related discipline
3-5 years’ experience working in Quality Assurance role or in a QA environment in the pharmaceutical industry (in a clinical manufacturing/packaging environment preferred) to support the manufacturing of drugs, biologics, or devices
Must be flexible and comfortable with ambiguity in a “start-up” environment

174

QA Specialist Resume Examples & Samples

Bachelor's Degree or equivalent in a related life science/technical discipline
5+ years experience in a regulated industry, or equivalent combination of education and experience
Experience working in or support software development projects
Ability to write clear and concise summaries of complex technical topics
Problem solving, decision making, time management, organization, communication, leadership and computer skills
Strong understanding of GMP and quality systems

175

Call Center QA Specialist Resume Examples & Samples

Listen to and score CSR calls from all support center using Quality tools and scorecard
Reviews customer satisfaction responses and provides necessary feedback to management
Ensures customer follow up on calls or surveys that warrant Client Services attention
Spends 40 hours a week monitoring phone calls and reviewing customer feedback
Verifies that proper internal processes are followed, customer services skills are used and scripts were used where needed or requested
Identifies calls that are at the highest level ensuring employee is recognized for his or her excellence
Identifies excellence that can be used during training and coaching meetings
Identifies calls that may require additional coaching or training and works with Call Center QA Supervisor and/or Support Center Leadership
Identifies and addresses customers at risk and recognizes ways to retain and/or increase satisfaction
Participates in semi-annual calibration sessions with Call Center QA Supervisor, Support Center Leadership, CSRs, and other stakeholders to ensure scoring consistency. Makes recommendations for changes and improvements to scorecard/survey to meet company standards
Make recommendations that will improve sales, service, and overall well-being of our company
May be asked to assist on phones or support cases when needed
Complete special projects as assigned by management
Other job-related duties as assigned by Manager

176

QA Specialist Resume Examples & Samples

Conducts QA monitoring and reviews/analyzes data and documentation
Proactively identifies trends based on monitoring and provides formalized feedback to leadership
Ensures data and information are sufficiently accurate and reliable
Provides input in development and implementations of performance improvement initiatives
Provides coaching feedback to Supervisors who will then relay to front line staff
Makes recommendations for solutions
Facilitates calibration sessions with leadership to ensure scoring accuracy and shares best practices for coaching and monitoring
Reviews graded scorecards for accuracy/calibration
Additional projects as needed
Strong understanding of all parts of Wholesale (i.e. Subject Matter Expert)
Experience using a consultative approach toward delivering feedback
Proven track record for quantitative and qualitative monitoring results
Intermediate to advanced business productivity software experience – emphasis in Outlook, Excel and PowerPoint
Effective verbal and written communication skills
Ability to multitask and perform in constantly changing environment
Exceptional active listening skills

177

QA Specialist Resume Examples & Samples

Education: Associates Degree or Bachelors degree in Nursing
Experience: 3-5 years as a RN in Acute Care setting
Skills & Abilities: None

178

QA Specialist Resume Examples & Samples

Bachelor’s degree in chemistry, microbiology, or related scientific field
Proficient in Quality Systems and CGMP standards applicable to clinical and commercial products and AD/QC laboratory operations. Knowledge of European regulations is desirable
Excellent attitude with good verbal, interpersonal communication, excellent judgment and multitasking skills who can adapt to changing priorities
Ability to recognize deviations from accepted practice and apply knowledge of current Good Manufacturing Practices (CGMP) on a daily basis
Excellent technical writing skills when creating and presenting reports for management. Ability to work independently in a high-paced environment with tight timelines, while maintaining accuracy and quality. Ability to effectively present data, findings, improvement initiatives/projects to QA and cross-functional leadership
Use of Empower for single and multi-wavelength assays and LIMS with single and multi-component compounds highly desired,
A relevant background in Quality Control or Analytical Development working as a team leader or supervisor is highly desired

179

QA Specialist Resume Examples & Samples

Action Oriented -Enjoys working hard; is action oriented and full of energy for things he/ she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others
Perseverance - Pursues everything with energy, drive and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
Intellectual Horsepower - Is bright and intelligent; deals with concepts and complexity comfortably; described as intellectually sharp, capable and agile
Problem Solving -Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers
Peer Relationships - Can quickly find common ground and solve problems for the good of all; can represent his / her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers
Decision Quality -Makes good decisions (without considering how much time it takes) based on a mixture of analysis, wisdom, experience and judgement; most of his / her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions
Interpersonal Savvy - Relates well to all kinds of people - up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can defuse even high-tension situations comfortably
Basic Computer Skills (windows based software)
Basic written and effective communication skills
Ability to take direction and execute in a fast paced environment
Technical skills as it relates to machinery, and ability to troubleshoot
The ability to demonstrate strong operating knowledge of manufacturing equipment
High School degree

180

QA Specialist IV Inspection & Audit Management Resume Examples & Samples

Advanced years of experience in GMP environment
Intermediate years of experience in Quality Assurance
Biotechnology manufacturing background is required
Advanced knowledge of cGMP’s and regulations

181

Principal QA Specialist Stability & Process Control Resume Examples & Samples

Manage the Stability Program and Manufacturing and Quality Control Process Review systems
Provide Quality oversight, approval, and guidance to internal and external customers for the drug substance and drug product Stability Programs
Approve changes to QC assay controls and standards
Provides Quality oversight and approval of the manufacturing and QC process review program
Acts to ensure that the manufacturing and QC method/standard review process is consistent with company policy and industry/regulatory expectations
Makes quality decisions related to identified trends and unexpected results in manufacturing and QC data
Supports regulatory/internal audits, may present the process and systems associated with process control and stability
Authors or approves trend reports and statistical data evaluations
Provides SME support for deviations, change control, validations, procedural changes related to QC methods
Chairs or acts as QA point of contact at QC and manufacturing process control meetings
Provides data analysis and statistics to support local and global quality meetings
Bachelor’s Degree in a scientific discipline, or an equivalent combination of education and experience
Minimum of 7 years of industry experience
Knowledge and experience in biopharmaceutical subject matter areas including: Manufacturing of bulk, intermediates and final containers; Product disposition and release; Discrepancy management; Aseptic processing
Expert knowledge in statistics
Expert knowledge of QC method development and assay control/standard monitoring programs
Experience in continuous process verification and manufacturing critical quality attribute monitoring programs
Excellent communication skills, good presentation and influencing skills
Ability to effectively manage multiple, complex priorities
Ability to work cooperatively in teams and peer relationships

182

Linguistic QA Specialist Resume Examples & Samples

Experience with CAT tools such as Trados Studio
Authoring and production tools such as Word, InDesign, FrameMaker, Acrobat, Adobe Creative Suite
Confluence
Sharepoint
Knowledge of Web technology and Content Management
Localization workflows and industry best practices

183

RA QA Specialist Resume Examples & Samples

Oversight of quality personnel assigned to each of the Divisions within S. Korea to ensure compliance with MFDS regulations for imported products
Prepare Quality Records, including product inspection, import and release, including returned products, as needed
Supervise label management to eliminate risk associated with local labeling process
Develop and maintain Quality Management System in compliance with MFDS regulatory and internal requirements
Responsible for product complaints, including receiving and reporting complaints to appropriate manufacturing sites, following up on complaint investigation, and preparing customer response letter in local language. Execute and manage NCR and CAPA as necessary
Implement Quality holds as needed and work with manufacturing site QA and RA teams for field actions and recalls
Train Korean organization of MFDS regulations and quality requirements
Audit/monitor internal quality compliance level, as well as daily quality performance
KGMP inspections for foreign manufacturing sites
Registration of products per regulations and communication with government officials
Submissions to support nHTA and HIRA registrations to enter the medical market
Clinical trial preparation for MFDS, nHTA and HIRA registrations
Maintenance of records on legislation, regulations, guidelines and regulatory files; updates & maintenance of paper/electronic document archival systems
Product type testing in Korean test laboratories to support product approval
Work with internal & international project teams in all Thermo Fisher Scientific Divisions to provide guidance on regulatory requirements to key stakeholders
Provide regulatory input to product lifecycle planning and communicate regulatory information to stakeholders

184

Systems Supp IT / QA Specialist Resume Examples & Samples

Carries out activities relating to the implementation, maintenance, configuration and upgrades of our client Systems
Builds new procedures and documentation for support/installation of new/existing our client System Products including the development of field installation standards
Provides direct Technical Support to Systems Customers including after-hours coverage
Installation and maintenance of employee work stations and devices
Provide maintenance to the regional network, including internet and connectivity issues

185

Product Development & QA Specialist Resume Examples & Samples

Responds to and manages consumer inquiries, including complaints, and associated email box
Coordinates the organization of incoming receipt and storage of product shipments
Coordinates product cuttings and vendor samples on assigned projects
Assists with the set-up and administration of sensory taste panels
Maintains the Test Kitchen facilities in accordance with the guidelines of the local Health department which includes cleaning and maintaining the test kitchen as needed
May provide administrative support to the department including projects such as preparing correspondence, department mailings and maintaining department documents
Collects, reviews and consolidates data/information for department use in special projects or reports. Reviews information/data and makes decisions within well defined guidelines, parameters, and instruction
Creates and maintains complex records including vendor facility audit documentation and department reports

186

QA Specialist Resume Examples & Samples

Assists in establishing and documenting a tailored strategy quality plan for the performance of quality assurance activities for assigned project or task
Gathers, uses and independently analyzes defect metrics data. Communicates analysis findings to appropriate level verbally and through the preparation of periodic written reports
Good communication skills to interact with team members, customers, and support personnel
Basic personal computer and business solutions software skill
Ability to handle activities on multiple projects and tasks within the same or different accounts
Basic ability to handle multiple project and task responsibilities simultaneously and switch among them quickly to meet prioritized business needs

187

Software QA Specialist Resume Examples & Samples

Plan, coordinate and manage overall testing approach and strategy for large complex projects working independently or leading other test analysts
Lead and collaborate with project teams to understand complex requirements, create effective test plans and scripts for large projects
Improve overall department’s testing effectiveness and efficiency by identifying and implementing continuous improvements
Analyze and implement strategies for leveraging QA tools and techniques to create measurable improvements
Provide thought leadership to continuously improving Agile development practices

188

QA Specialist Resume Examples & Samples

Verification of the company’s compliance with ISO/cGMP quality system requirements as well as knowledge of 21CFR210, 211, 610 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1
Provide immediate support to operations and quality control staff to address compliance related concerns (QA “on-the-floor” support)
Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams
Audit internal quality system elements in manufacturing and operational support areas
Provide oversight for compliance of CA/PA and investigations, OOS and deviations
Perform external audits of suppliers/vendors/off-site facilities
Act as a customer interface during on-site audits, conference calls and other standard means of communication
Independently identify and manage special projects or QA compliance functions as agreed upon with QA management
Prioritize and manage a variety of projects simultaneously
May need to lead and direct the work of others
Review Device History Records (DHR) and Master Batch Records (MBR) and supporting documents. Perform review/release of batch records, as needed

189

QA Specialist Resume Examples & Samples

Providing technical expertise in quality risk management to a broad base of customers throughout the IOPS organization, including Quality Assurance, Quality Control, Manufacturing, Medical Device and Facilities
Facilitating data driven risk assessments and risk reviews
Formulating strategies for risk controls and mitigations
Preparing and revising QRM documents
Developing and improving the quality risk management program

190

Senior QA Specialist Resume Examples & Samples

Leading and/or contributing to system, product and process improvement projects
Leading and/or contributing to site-to-site transfer projects
Supporting product design and development projects and risk management activities
Administering and coordinating product design history files and design reviews
Contributing to the development, approval and implementation of product labeling and instructions for use
Supporting equipment, process and facility qualification and validation activities
Supporting with regulatory submissions
Aid in implementing process improvements with respect to Quality Assurance processes
Provide support (management/execution) with CAPA, change requests, deviations and NCMRs
Manage training program
Manage complaints as required
Manage supplier qualification program
Review and release batch records
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Demonstrates commitment to the development, implementation and effectiveness of Ameditech's Quality Management System per ISO, FDA and other regulatory agencies

191

QA Specialist Resume Examples & Samples

Follow company policies andprocedures
Maintain a state of inspectionreadiness
Provide input to the development ofpersonal performance goals and departmental objectives
Meet assigned targets and timelines
Prioritize assigned tasks within afast paced environment
Participate in process improvementand system design teams
Provide assistance to customers insupport of departmental functions
Work with colleagues to maintaincross-functional and cross-site process and procedural consistency
Apply advanced theory and technicalprinciples to address routine problems
Troubleshoot and assist in theresolution of Quality issues by fostering effective interdepartmental andcross-functional partnerships
Sign documents for activities as EQAas described by Roche/Genentech policies and procedures
Be accountable for behaviors asdescribed in Roche values and leadership competencies
Perform other tasks as requested byManagement to support Quality oversight activities
Manage the environmental monitoring(EM) and aseptic media fill programs
Support validation activities fornew equipment, facilities and utilities
Provide technical assessments andapprovals for changes to the environmental control program to ensureconsistency across manufactured products
Present and provide rationale ofenvironmental control programs during internal and partner audits andregulatory inspections
Provide input in the preparation ofregulatory submissions related to the environmental quality of Genentechmanufacturing facilities and processes
Provide quality oversight to ensurea compliant EM and pest control program
Perform and assess air flowevaluations
Collaborate and author departmentpolicies and procedures
Serve as the Quality representativeon cross-functional and multi-site teams
Identify, design, and implementprocess and system improvements
Apply advanced theory, technicalprinciples, expert judgment, and cross-functional expertise to independentlyaddress a broad range of complex problems
Troubleshoot and direct theresolution of Quality issues by fostering effective interdepartmental andcross-functional partnerships
Serve as a technical subject matterexpert (SME) in support of department functions

192

QA Specialist Resume Examples & Samples

Have Chemistry/Food Technology/Pharmacy degree
Knowledge on Quality and Food Safety System
Team working skills
1 - 2 Years of experiences in the same field

193

VBF QA Specialist Resume Examples & Samples

Direct in-line Quality support for all cGMP compliance, batch review, and environmental monitoring matters
Review and approval of batch record documentation (electronic batch record comment resolution, RT reports, autoclave records, review and approval of electronic and paper batch records as applicable)
Provide Quality oversight to alarm events (non-viable particles, differential pressure, temperature, and humidity) during processing
Review and classification of atypical events including accessing product impact for EM events
Author and review SOPs specific to the IPT
Investigate OOS results and/or laboratory atypicals
Evaluate environmental data and OOS reports for adverse trends
Observe and audit media challenges
SOP development and review
Direct support of validation activities and all other associated quality functions
B.S., B.A., or M.S. degree in Science, Engineering, or equivalent experience
Minimum 3 -7 years experience in pharmaceutical operations, technical services, and/or quality operations with at least 2 years in a quality function or targeted training in quality to perform the defined responsibilities
CGMP in pharmaceutical industry; ability to aseptically gown, previous QA experience
Ability to work independently, previous paper batch record review experience
Knowledge of CFR regulations,

194

QA Specialist Resume Examples & Samples

Participating in the CAPA process to ensure compliance together with the team
Participating in daily support in CAPA handling and follow up
Ensure good CAPA quality by QA review
Responsible for overall CAPA trending
Being part of CAPA training of organization

195

QA Specialist, / Ii-product Assurance Resume Examples & Samples

Review and approve commercial, clinical, and device batch records for compliance with all applicable internal procedures and federal regulations
Conduct independent inspection, review and release of direct and indirect manufacturing materials upon incoming receipt
Issue logbooks to requested departments. Review/approve logbooks in warehouse, label control and manufacturing suites for accuracy and completeness of data
Ensure accuracy of label reconciliation. Print, issue and perform routine cycle counts of printed components maintained in label control
Coordinate and respond to document inquires for certificate and archived files from internal and external customers
Revise/create Standard Operating Procedures (SOPs) and internal specifications
Provide timely and accurate reports for assigned project(s) and quality metrics to the QA Manager
File and index all quality documents for internal and external archival
Perform other related assignments and duties as required and assigned
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe. Working knowledge of MasterControl, SAP and TrackWise
Must be able to work in a cross-functional team environment with the ability to multi-task and continuously demonstrate the initiative to solve problems independently while exercising good judgment and discretion
Must have the ability to work under stressful conditions with a sense of urgency and exercise critical thinking
Must have effective interpersonal, written and verbal communication skills

196

Test / QA Specialist Resume Examples & Samples

Graduate Degree preferred
7+ years relevant experience
Readiness to serve as an advisor to management and team and provide expertise on leveraging testing assets and practices across TD Technology Solutions
Proficiency in developing test strategies for highly complex and multi-faceted projects
Ability to advise on testable software builds, test data / environment / configuration / defect management, test asset control
Talent in identifying risks both within and across projects and recommending ways to mitigate them
Strength at managing and directing activities related to analysis, design and support of technical business solutions on larger projects
Expert knowledge of QA methodology, best practices and processes while contributing to testing methods and tool selection direction
Strong knowledge in project financial management and reporting. Sound knowledge of external industry trends in relation to competency
Knowledge of principles, practices and IT processes appropriate to quality delivery development and stewardship

197

QA Specialist Resume Examples & Samples

Directly responsible for performing all Quality functions for assigned lines which include, but are not limited to
PTA Oversight: Oversee and train PTAs to desired levels of competence
Daily scheduling of PTAs
Audits: Perform routine monitoring for conformance of all related batch documents, logbooks, Standard Operating Procedures, etc
Key Performance Metrics: Monitor and take action to improve adverse variance trends i.e. deviations, re-works, in-process checks, AQL sampling, documentation accuracy, etc
Decision Making: Make and communicate routine real-time decisions on Quality issues regarding documentation, product, defects, etc. Escalate issues appropriately
Corrective Actions: Take appropriate (real-time and post event) corrective action in response to audit findings
Preventative Actions: Take action to eliminate the risk to the end user, recommend/implement preventative action to prevent recurrence, monitor success of preventative actions and follow-up appropriately
Documentation Completion: Complete and issue Off-line re-works, deviations, event forms, re-issue batch record documents, prepare hold tickets and quarantine request forms, etc
Continuous Improvement: Identify, deliver, manage and roll out specific improvement projects
Customer Samples Preparation and Batch Release
Perform Specific Duties and activities of PTA as needed
Proficient in the use of software (e.g., word processing, spreadsheets, database software etc.) is preferred
Must possess appropriate communication skills allowing direct interaction with STW internal Managers and Sr. Management
Foster teamwork to get results
Well organized and multi-task oriented
Must be able to perform risk assessments in a timely manner and act in conjunction with behavioral standards
Demonstrate initiative. Develop ideas, and collect them from others. Continuously seek improvement opportunities

198

QA Specialist UTC Resume Examples & Samples

Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
Support the development of GMP training packages and delivery of training
Participate in the preparation and review of procedures and batch documentation
Perform audits of all departments to agreed schedule
Ensure the quality system at Genzyme is effectively implemented and maintained
Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
Work with relevant departments to ensure timely closure of quality actions / findings
Actively contribute to continuous improvement initiatives
Conduct duties in a safe manner and report all safety issues or concerns
Maintain work area to good housekeeping standards
Ensure attendance at place of work when required
Support team in achieving team goals/targets
Attend team meetings as required
Measure and report RFT / trend data and work with departments to resolve recurring issues
Support investigation of deviations ensuring all product deviations are closed prior to product release
Ensure compliance to cGMP at all times
Third Level qualification essential (degree in science or related discipline preferred)
Minimum of 2 years’ experience in a similar role
Working knowledge of computer packages

199

Senior QA Specialist Resume Examples & Samples

The Software Engineer is Test will be responsible for developing & executing functional tests as well as implementing automated tests for Strategic Platform - our Analytic -based investment risk and performance attribution platform. QA Engineers combine their knowledge of testing complex software applications with their understanding of financial instruments, markets and risk. Tests are automated via a variety of tools in a JavaFX-centric environment
The QA Engineer will be given increasing responsibility for aspects of Quality Assurance in the ProjectONe systems. Duties will include
Implement, maintain and run automated and manual tests
Own and expand an automation suite written in Java using Web Services
Analyze requirements specifications for impact on the existing system as well as for gaps, testability, and applicability to stated use cases
Create and review test plans for coverage, efficiency, and efficacy
Amplify the effectiveness of local and global peers
Document and communicate findings for further action
Identify and diagnose issues quickly and accurately for impact on customer and the whole system
In addition, the role requires extensive coordination with QA, Development, and Product Management staff in our other development centers
5-8 years overall Software QA and test automation experience
Proven experience with test frameworks written in Java. C# programming experience also desirable
Knowledge of finance including equity and fixed income, financial data, and financial topics and the interest to learn such topics is desired
Experience with the Selenium, TestFX, TestComplete test framework
Experience with the core concepts of functional programming
Platform skills: Linux
Tools: Gradle, Stash, JIRA
Education: BS in Computer Science /Math/Statistics/Finance or a related field. Prefer Master's degree

200

QA Specialist Resume Examples & Samples

Implement MJN Quality Systems to support business strategies by ensuring compliance to MJN Quality Manual and applicable local regulatory requirements
Assist in communication of Global policies and procedures at the local level
Support Quality System awareness enhancement programs
Gather and review site functions’ Quality performance for trends and identify continuous improvement opportunities for sharing in the monthly Quality Meeting
Implement internal audit program and ensure compliance to requirements of

201

QA Specialist, TPM Resume Examples & Samples

1) Provide support to Supply Chain TPM operations
Perform routine disposition/release of conforming materials and products
Create and transmit product certificates of analysis (COAs) and documented release decisions
Review and perform statistical analysis of product performance data to support root cause analysis
Monitor reassay, check and monitor tracker, follow up any delay, weekly review with TPM team
System set up (SAP, GLIMS) and maintenance for all TPMs
Verify invoices from third party laboratory
Communicate changes to TPM through cover letter
Assist in crisis situations, such as a potential product recall, customer complaint
Coordinate testing with MJN and third party laboratory
Ensure materials releases within lead time
2) Provide support to quality systems and document management system
Provide support in finalizing and archiving of QA technical documents and reports including change notification, exceptional release, ship on test, etc
Develop and maintain the MASTR in GLIMS for all materials (RAW, PACK, HALB)
Provide quality documents as required by internal audit team quarterly basis
Creation and maintenance of a local document control system, and coordinate with other site functions’ document administrator to ensure local SOPs are aligned with current global and regional practices
3) Provide support to supplier performance management
Update raw materials supplier performance and scorecard for all TPMs
Consolidate supplier performance until Senior Specialist on board

202

QA Specialist, / III Resume Examples & Samples

Support the validation state of Internal Systems (PMD, RAR, LRA, LIMS)
Oversee and implement documentation concerning the validation of External Systems (IRT) across the GMP and GCP arenas
QC review data entered into, existent in, or autonomously generated by Internal and External Systems during system life
Represent Quality in collaboration activities concerning Internal and External Systems
Support Packaging and Labeling and Lot Disposition Quality Groups in performance of standard IMP packaging operations
Carries out technical evaluations of specialized systems or processes in a team of quality professionals
Gathers and analyses quality related data to ensure a high standard of quality is maintained and identify potential areas of concern
Provides a basic level of technical support for more straightforward quality related problems
Helps implement improvements in quality related business process
Adheres to defined processes and quality management systems
3-4 years of related job experience. Industry experience required
Professional certification(s) desired
Experience with Trackwise and/or non-conformance investigation experience a plus

203

Underwriting QA Specialist Resume Examples & Samples

Coordinate cross-regional underwriting self-review cycles
Coordinate home office SBU underwriting review cycles in accordance with Sarbanes Oxley requirements
Receive and review underwriting review summaries and reports, and, aggregate to an enterprise view
Analyze underwriting review summaries and reports such to assess negative and positive trends
Generate solutions for needs-improvement within the underwriting community – partnering with SBU, LOB, Legal, Compliance, Information Technology, Business Support Unit, (BSU) and Training functions as warranted
Participate in underwriting review wrap-up sessions
Ensure adequate controls for corrective action plans derived from regional and home office underwriting reviews
College degree in risk management, business, finance or a related field preferred
5+ years of commercial lines underwriting experience
Certifications in underwriting profession desirable – examples being CPCU, ARM, CIC, IIA
Strong multi-line underwriting technical skills
Understanding of state and regulatory requirements in the insurance industry
Excellent verbal and written communication skills, including collaboration, ability to influence and presentation abilities
Consulting experience a plus

204

QA Specialist, Product Resume Examples & Samples

Obtain a detailed understanding of the behavior of (and issues affecting) the SHOWTIME standalone streaming service and Showtime Anytime across all platforms
Perform tests of new features and functionality on the SHOWTIME standalone streaming service and on Showtime Anytime
Prioritize and collaborate with other team members to resolve issues interfering with the customer experience

205

QA Specialist Resume Examples & Samples

Support validation of patches through test development and execution
GxP/quality review of records, including operations checklists and test scripts
Maintain repository of customer facing deliverables for distribution (VeevaDocs)
Coordinate customer RFI/RFP requests and customer postal audits
Coordinate supplier management audits

206

QA Specialist, Documentation & Training Temp Resume Examples & Samples

Coordinate and maintain the Documentation and Training programs, as a means to ensure patient safety, product quality, and overall compliance, within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to
Manage Document Control processes and systems
Ensure consistency of documentation and compliance with internal policies and standards
Conduct and champion documentation control actions in a validated computer system
Prepare and analyze metrics for management review and escalation of issues
Participate in quality and process improvement initiatives and project teams
Identify opportunities for process and system improvement and enhancement
Manage Document/Record Archive Program
Maintain appropriate filing structure to keep archived material identified, secure, and easily retrievable when needed
Maintain appropriate chain of custody for controlled documents submitted for archival
Maintain archive database for accuracy of documentation details and location
Retrieval of documentation upon internal customer request and during inspection activities
Prepare and coordinate documentation transfer to offsite archive
Support and advise end users on document system requirements and workflows
Evaluate questions and issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, and escalate to management as appropriate
Identify user issues and trends for system, procedure, and training improvements
Conduct user training sessions for document control system and procedures
Support of the GxP Training Program
Collaborate with document authors to development appropriate training materials and exams
Bachelors Degree in science or related field and 3+ years of successful quality assurance related experience
Proficient in Microsoft Word, including document formatting, application of styles and numbering, tracked changes and comments
Comprehensive knowledge of good documentation practices and document control concepts
Knowledge of quality assurance principals, best practices, and quality systems used in a manufacturing environment
Demonstrated ability to coordinate process improvement initiatives and quality system related projects
Knowledge of both domestic and international cGMP regulations
Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, auditors, contractors and consultants

207

QA Specialist Resume Examples & Samples

Coach and train others on change control tools and processes and evaluate change control processes and tools to drive continuous improvement. Monitor and communicate metrics and trend reports to management for the Change Control system
Lead Change Control Committee meetings and act as point of contact for notification of partner change notices and inter-company change control related communication
Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory. Experience in change control function strongly preferred
Proficient computer skills in Microsoft (MS) Word, Excel and PowerPoint required. Experience with ProcessCompliance/QUMAS heavily preferred
Requires BS/BA in scientific or engineering discipline or related field with 3-5 years combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory experience, with demonstrated accomplishments in effectively implementing cGMP requirements

208

Junior QA Specialist Resume Examples & Samples

Execute a wide range of quality assurance test procedures for various ad products in order to ensure that specified standards and end-user requirements have been met
Log defects, document findings, and work with other personnel towards a successful resolution
Prepare defect lists and status reports for stakeholders
Continuously refine the QA process to ensure the delivery of high-quality, error-free deliverables
Maintain a suite of test devices, monitoring tools, test plans and test cases documentation
Must be willing to work flexible hours from time to time
Automation experience is welcome, but is not required (Java, Ruby, PHP)

209

QA Specialist Resume Examples & Samples

Test legacy and new test cases with the use of format test cases or scripts. Execute smoke, regression and functional tests
Ability to go beyond the specification and anticipate problem areas in the product design and document test cases results and compare expected results
A Bachelor's degree in a field such as Computer Engineering, Mathematics, Science or any related field is preferred; candidates with higher degrees are strongly encouraged to apply
Demonstrates knowledge of standards of excellence for products and services within own area
Demonstrates understanding of how own role contributes to the team; seeks clarity in assigned responsibilities when necessary
Authentically communicates clearly and concisely with others
Recognizes routine customer issues while understanding relevant project implications
Demonstrates knowledge of the skills, tools and requirements needed to support projects within the domain; seeks opportunities to build domain knowledge
Analyses information in order to help identify the root causes of problems occurring at the project level
Collects and summarizes raw data to determine risk probability

210

QA Specialist Resume Examples & Samples

Maintain a state of inspection readiness
Work with colleagues to maintain cross-functional and cross-site process and procedural consistency
Apply advanced theory and technical principles to address routine problems
Sign documents for activities as EQA as described by Roche/Genentech policies and procedures
Be accountable for behaviors as described in Roche values and leadership competencies
Perform other tasks as requested by Management to support Quality oversight activities
Manage the environmental monitoring (EM) and aseptic media fill programs
Support validation activities for new equipment, facilities and utilities
Provide technical assessments and approvals for changes to the environmental control program to ensure consistency across manufactured products
Present and provide rationale of environmental control programs during internal and partner audits and regulatory inspections
Provide input in the preparation of regulatory submissions related to the environmental quality of Genentech manufacturing facilities and processes
Provide quality oversight to ensure a compliant EM and pest control program
Perform and assess air flow evaluations
Collaborate and author department policies and procedures
Serve as the Quality representative on cross-functional and multi-site teams
Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems

211

Senior QA Specialist Resume Examples & Samples

Manage document control process through MasterControl. Track Standard Operating Procedures (SOPs), forms, and other regulated documents to ensure timely and accurate review and content
Ensure that all SOPs are written in accordance with GCP/GCLP standards and CLIA/CAP guidelines
Recommend, create, implement, and update SOPs, as necessary, to improve processes, and support compliance
Support improvements and maintenance of the Quality Management System (QMS)
Support the maintenance of the employees Technical Training Files
Conducts or contract internal and external audits according to the audit schedule and maintains and updates audit schedules and logs
Performs qualification and periodic audits of contracted vendors
Provide support to the QA team during regulatory agency inspections or third party audits by participating in inspection preparation and assisting the inspection strategy room
Support the preparation of timely responses and closures to client audits
Support efforts to verify that appropriate corrective actions are taken as a result of audit observations and investigations as necessary
Provide support to the team with the validation of the laboratory equipment, and IT systems
Responsible for maintaining certification/accreditations/licensures records for the laboratory
Oversee the organization and maintenance of all laboratory binders
Contribute to the team effort by accomplishing related duties as needed
Bachelor degree equivalent in Biology, Microbiology, Clinical Laboratory Science, or related field
Previous experience in a clinical/research laboratory environment, oncology environment a plus
Solid expertise and working knowledge of 21 CFR Parts 21 and ICH guidance documents
Solid knowledge of CAP, CLIA, New York States regulations, including successfully having completed at least one CAP inspection
Strong organization skills, with the ability to organize, plan, prioritize work, and manage multiple clinical projects effectively, within agreed upon timelines
Strong interpersonal skills, with the ability to positively interface with individuals at all levels of the organization
Strong professional communication skills, including written, verbal, and presentation
Strong attention to detail with an ability to perform critical review of various types of technical documents

212

Opqss Customer Incident Management QA Specialist Resume Examples & Samples

Biological manufacturing processes knowledge is an asset
Fluent English and French, spoken and written
2 years of industry experience, preferably within the Pharmaceutical Industry
Ability to engage people from different areas of expertise
Ability to work effectively in a highly matrixed organization across geographies and cultures
Ability to work in a regulated environment of pharma / biopharma / vaccines industry
Ability to communicate complex information both orally and in writing
Has the technical competency to evaluate investigations, product issues, etc. Incumbent does not need to be a subject matter expert, but must have the ability to ask questions that lead to the discovery of root causes
Ensure complaints are recorded, investigated adequately and answered in a timely manner for GSK vaccines worldwide (More than 120 markets)
Analyze complaint trends and manage complaints in such a manner to prevent recurrence of complaints, major incidents and recalls from the market
Manage technical signals seen on certain batches in accordance with procedures in place
Maintain continuous interactions with the Pharmacovigilance dept. in order to ensure appropriate investigation of safety signals and safety review of potential quality issues
Contribute to the continuous improvement of the Complaints Management System
Participate actively in taskforces related to Complaints
Respond to external (GSK commercial units) and internal (Manufacturing sites, Safety, etc.) clients' needs through explanation and clarification of issues and reporting (per building, site, product, country, topic )
Participate to the management of serious product incidents on vaccines, which may lead to product recalls and communications to authorities, by being the secretary of the Product Incident Review Committee; which is a cross-functional and multidisciplinary team involving representatives (Directors, VPs) from different departments as Quality Labs, Regulatory, Legal, Safety, Medical, and Communications which mission is to evaluate and decide if a batch must be recalled. Liaise with the GSK Corporate to ensure the Product Incident Management Process is respected
Coordinate vaccine recalls when needed
Represents GSK Vaccines in case of inspection by Authorities to defend Technical Complaints and Recall systems; prepare inspection-ready documentation and more generally offer support in case of inspection

213

BC Contractor & QA Specialist Resume Examples & Samples

Work with the leadership team to identify key process performance metrics. If metrics are not currently measured, work with team to develop measurement system
This individual will have an increased focus on providing coaching, training, daily oversight and reporting of activities related to the installations and services provided by the Business Class Contractors
Establish improvement and sustainment targets for metrics and facilitate exception-based discussions when measurements are out of acceptable range
Continuous Service Improvement ITIL certification or understanding
Bachelor's degree; or equivalent training, education and experience

214

QA Specialist Resume Examples & Samples

Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation
Objectively monitor Agent-Customer interactions to ensure engagements are of high quality and high customer satisfaction and adherence to the policies and procedure of the organization
Attend and co-facilitate client calibration sessions with QA Manager or Lead QA Specialist
Provide feedback to assist in the creation of performance improvement goals and training programs
Conduct customer survey analysis, chat transcript review and agent mystery shopping
Conduct live internal/external audits to identify competitive positioning of chat and surface best practices that can be leveraged for optimization
May participate in limited coaching sessions, focus groups, and group training with agents
Complete quality assurance monitoring forms and related documents
Maintain a training library of strong and opportunity chat examples for coaching/development
Create and maintain QA records for assigned agents
Promote teamwork within the department and actively participate in quality, conversion and customer satisfaction improvement efforts
Assist with EPA and chat proficiency assessments
Must be a self-starter, personable and motivated person who enjoys working in a team environment
Strong organizational skills and strong attention to detail, yet can be flexible and able to incorporate changes efficiently in a short amount of time
Must have excellent verbal and written communication skills and must be able to interact effectively with all levels of employees and departments
Must be proficient in Microsoft Excel

215

Healthcare QA Specialist Resume Examples & Samples

Claims Auditors supporting the following Clients: GWY, MTC, NHPRI
Claims Auditor supporting Trusted and Sr. Administrative Specialist
Perform analysis, provide reports to management, and recommend appropriate actions
Mentor less experienced associates
Work on complex projects

216

QA Specialist Resume Examples & Samples

1-3 yrs. industry exp. specifically with a Microbiology focus
Responsible for the implementation, maintenance & improvement of the quality systems
Conduct and/or support GLP studies including but not limited to: master schedule maintenance, protocol review, and study audits

217

QA Specialist, Russia & CIS Countries, Moscow Resume Examples & Samples

Pharmacist/biochemistry/Biologist/Microbiologist (pharmacist degree and auditor skills is a plus)
External professional certifications is a plus
English fluent/intermediate
High proficiency with MS Office, Windows, SharePoint
3 years of experience in Quality management in a global/pharmaceutical environment
Ability to proactively anticipate multiple deadlines, and drive and manage project priorities
Excellent interpersonal skills and the ability to interact with staff on all levels and within a culturally diverse environment

218

QA Specialist Resume Examples & Samples

Audit prefund, closed, cancelled and denied loan files within established timeframes, utilizing the Audit File Checklist and TENA software
Request the files that were selected in sample from the appropriate department
Secure the necessary reports (credit & appraisals) as required
Mail out verifications to re-verify all information used in making the lending decision on closed loan files
Track the receipt of reverifications and analyze the information returned
Report any questionable items or inconsistencies to manager
Coordinate data from Accounting and Secondary Marketing as necessary
When findings are received, assist in the preparation of audit data for responses to the relevant institutions
Respond to individual HUD & VA audit requests for closed loans as required
Review automated underwritten loan files to validate data
Assist in the preparation for state, agency and investor audits
Audit Ryland title and settlement services files in accordance with established guidelines and plan
Prepare HMDA reports for submission to HUD annually
Review reports of all HMDA data maintained in the processing system
Coordinate corrections of HMDA data exceptions and forward files to outside contractors for geocoding
Maintain the HUD required HMDA register
Work closely with the Operation Center staff to resolve regulatory questions on files
Analyze files run through fraud software to address discrepancies
Prepare and distribute Exception Reports/Individual Summary Reports to inform designated personnel (i.e., Loan Processors, Loan Closers, Underwriters) of the exception findings
Retrieve files and ship to various requestors as needed
Participate in monthly preparation of the audit sample selection
Assist processing staff in clearing Compliance Ease/Mavent alerts
Be familiar with and at all times comply with the Company’s Code of Business Conduct and Ethics, the Company’s Employee Handbook and all other Company policies and procedures, as each may be in effect from time to time
Do not engage in any fraud, misrepresentations, or any other illegal activity
High-school diploma, 4-year college degree a plus
Previous underwriting experience is a plus
Extensive knowledge of FHA/VA, FHLMC/FNMA guidelines and federal regulatory requirements
Strong computer skills (i.e., MS Office a plus, AUS systems)

219

QA Specialist Resume Examples & Samples

Analyze defects found during testing to identify likely root cause and create defect reports
Assist in streamlining and improving the daily test processes
Working or learning Experience on Selenium, WebDriver and other automation technologies

220

Operational QA Specialist Resume Examples & Samples

Bachelor of Science or Engineering degree or equivalent
Advance user of Microsoft Office (Excel, Word, PowerPoint)
Pharmaceutical industry experience or experience within a highly regulated technical environment (2 yrs
Strong self awareness (both strengths and opportunities) and ability to self develop
Ability to adapt to change and work flexibly to overcome boundaries
Must be able to work days, afternoons, midnights and weekends on occasion
In-depth understanding of cGMPs
Proficiency in computer systems including SAP
Working knowledge of Statistical analysis, data trend analysis, interpretation, conclusion and

221

QA Specialist SAP Process & Data Management Resume Examples & Samples

Proactively identify potential quality processes risks and manage these risks through the dedicated risk register
Lead and coordinate a continuous improvement and compliance program to ensure processes are performing optimally both in terms of efficiency and compliance to department-specific and GSK standard requirements
Masters the key QA activities related to production, QC, maintenance and calibration, warehouse, CSV, validation, project activities in his/her area of responsibility
Represents QA (decision responsibility) in all meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPC follow-up meetings, …)
Ensures critical topics are adequately escalated to higher management

222

QA Specialist Resume Examples & Samples

Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations
Review and approve validation documents
Review and Master Batch Records (MBR) and supporting documents. Perform review/release of batch records, as needed

223

QA Specialist, Documentation Resume Examples & Samples

Review and approval of GMP documents – specifically batch related documents
Review and approval of non-batch related documents
Act as an editor for QA Quality systems group documents
Be involved in ongoing training and improvement activities
Provide support for other members of the QA Quality system group

224

QA Specialist Resume Examples & Samples

Job requires mobile use of hands and arms. Reasonable accommodations will be made for persons with disabilities
Excellent language and communication skills required
Must be able to clearly communicate responsibilities of solid documentation needs on a daily basis

225

QA Specialist Resume Examples & Samples

Serve as back-up recall coordinator [QM is primary]
Execute required testing of the traceability system [mock recalls]
Identify and follow up on corrective actions following tests of the traceability to ensure system is continuously improving and meeting regulatory requirements
9) Additional Quality Assurance Functions as needed

226

QA Specialist Resume Examples & Samples

Bachelor's Degree with minimum 5 years of biotech/pharmaceutical industry experience. Minimum 3 years of Quality Assurance experience
Master’s Degree with minimum 1 year of experience in biotech/pharmaceutical Quality Assurance. Experience working in a highly regulated environment (FDA, EMA)
Good understanding of basic scientific principles
Understanding of basic biotech manufacturing processes
Good understanding of cGMPs, regulatory standards and concepts
General knowledge of other related disciplines
Assists in oversight of complex projects and programs, interdepartmental and corporate goals
Supports strategy
May assist in the supervision of activities of other QA Specialists
Assists is training of other specialists

227

Software QA Specialist Resume Examples & Samples

Researching and resolving issues noted during system testing and regression testing
Assisting customer with user acceptance testing
Assisting with documentation and deployment of new or updated testing tools
Requires Bachelor's degree (Business, Information Systems, or related field) or equivalent and five to seven years of related experience
Requires strong analytical skills – ability to identify errors, determine impacts, and develop strategies to validate solutions
Ability to work both independently and with a team to solve problems
Initiative to quickly learn and apply new skills
Candidate should exhibit a superior degree of discretion and autonomy, be a fast learner, and be able to and interested in growing functionally and technically

228

Test / QA Specialist Resume Examples & Samples

Experience in automation using HP UFT and Advance programming in VBScirpts
Experience in automation using Selenium Webdriver, JAVA
Experience in writing SQL (data retrieval/update/inserts) on DB2 / Oracle / MS SQL Server
Good to have, knowledge on SQL server Integration Services Packages
Experience in using source code control systems GIT / Subversion
Experience in implementing continuous integration using Jenkins
Experience in working with JIRA
Experience in working in an Agile environment
Experience in Behavior Driven Development (BDD) approach and Cucumber
Knowledge of Testing methodologies and industry best practices
Knowledge of Canadian Banking and/or Wealth applications

229

Claims QA Specialist Resume Examples & Samples

Passion for service to our customers, internal and external
Able to work autonomously without constant supervision
Self-motivated / self-starter
Previous knowledge of Claims Processing, Reimbursement Accounts, Oracle CX are a big plus

230

QA Specialist Resume Examples & Samples

Maintains testing procedures required for the review process for proper versioning for Celgene products/test methods/specification as required
Significantly contributes to timely review of contract manufacturer’s batch and testing documentation and reported issues and exude confidence in making routine decisions related to their SME area on addressing and management of path forward with minimal oversight
Capable of providing input with department and cross functional teams, including CSPs, for administration, receipt, review of CSP documentation corrections
Schedules routine meetings internally and with CSPs in order to follow-up that requirements are being met
Reports into QO Batch Review Group meetings as required to update on the status of documentation review and pending items holding release, including any global issues
Performs training of Vendor Quality Manager (VQM) review/disposition requirements, for both internal and external personnel as needed
Generates review documentation and prepares batch disposition documentation
Responsible for the pre-disposition review for batch review
Generates CofAs and CofCs for batches as required
Required to perform tracking and trending of the batch review process, CSP batch review data as well as Incoming Quality Control data
Supports Qualification Process for designated CSPs. Works with CSPs to try and assimilate what will be required going forward to work towards this process, if not already qualified
Act as backup for final batch disposition as required
Provides support to VQMs and Quality Compliance Managers as required
Reviews changes controls related to test method/specification changes as required
Reviews/approves change controls related to labeling changes
Supports site Management Review and MQR/PQR process for site
Supports Health Authority inspections and audits of the site
Supports systems to facilitate timely finished product batch review
Performs investigations as required. Follows up to ensure corrective actions are implemented. Initiates/supports Management meetings/projects to facilitate timely product batch review
Maintains knowledge of current GMPs and regulatory guidelines
Acts as representation for Quality Operations and Compliance management as required
Performs supplemental investigations/projects as required by Management
Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams
Must develop employees and coach them to bridge knowledge gap
Most have strong authorship and be able to critically review reports while effectively inputting and expressing Quality risk management principles
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking

231

QA Specialist Resume Examples & Samples

At least 2 years’ experience in the creation of functional and automation testing strategy/test plan
At least 2 years’ experience in Software testing for established methodologies
At least 2 years’ experience in hands-on scripting automation experience including creation of test automation framework, design and test scripts
Excellent client interaction and communication skills
At least 2 year’ experience in scripting language
.Net or java programming skills

232

QA Specialist Resume Examples & Samples

8 to 10 years of hands-on work experience in QA
In-depth experience with Webservices
Understanding of Webservices automation
Prior experience in design of automation framework
Self motivated with an ability to take ownership and deliver
Strong communication and collaboration skills is a must.
Automation expertise in QTP/UFT, RIT, SOATest, or SoapUI
Devops experience a big plus
Having Agile, Rally, ALM hands-on experience
Client-side Automation in Java script or VBScript
Self-driven, highly-motivated individual to meet tight deadlines

233

Clinical QA Specialist Resume Examples & Samples

Lung SOPs and WI to provide adequate detail to achieve GCP compliance
Maintenance of SOPs and WI to follow current Lung/UT SOP for document control
Document reviews to be conducted per CQA SOP, checklist or other guidance document
CQA Associate to maintain a clear and effective filing system for all CQA deliverables and historic training records
Offer GCP and other training sessions based on needs of Lung staff
Maintenance of a GCP vendor list
Assures new hire orientation for Lung Document Control and Learning Management System takes place
Tracks Lung controlled documents to include regular status meetings with responsible parties throughout the year
Reviews and provides feedback of controlled documents content to responsible parties throughout the year and prior to revision
Assures GCP training or other necessary training is available and completed for all Lung staff
Maintains historical training records and CQA department records
Tracks and maintains a listing of audited GCP vendors
Tracks status of Lung Clinical Corrective and Preventive Actions (CAPAs)
Assists with CQA audit preparation, conduct and closure as need
Conducts document reviews as needed

234

QA Specialist Resume Examples & Samples

Assisting with customer questionnaires (SSAQs)
Preferably a minimum of BSc in Microbiology, Chemistry, Food Science or other Science subject
1-2 years’ experience in a QA position in a food/flavor laboratory or food industry is desirable

235

Scada QA Specialist Resume Examples & Samples

Provide technical expertise and guidance in the development of standards, procedures, tool selection and process improvement related to application development, maintenance, operation and system support activities that support the Northern SCADA system ISO 27001 and critical security controls efforts. This will require the development of a long term quality assurance program that will provide ongoing compliance and improvements related to ISO 27001 standards and critical security controls
Review requirements, specifications and technical design documents to provide timely and meaningful feedback
Create detailed, comprehensive, and well-structured test plans
Identify, record and document testing thoroughly
Perform thorough regression testing to resolve testing issues
Develop and apply testing processes for new and existing products
Liaise with internal teams to identify requirements
Monitor debugging process results
Track quality assurance metrics, such as defect counts and defect densities

236

Assoc QA Specialist Resume Examples & Samples

Investigate customer/sales representative complaints
Assure complaints are logged accurately and closed in a reasonable amount of time
Generate certificates of compliance/conformance/analysis
Run and distribute monthly and quarterly trending reports of complaints and initiate corrective action requests where appropriate
Update and train complaint coordinators SOP document on a quarterly basis and train coordinators on SOP
Write vendor letters and follow up with vendors on complaints for corrective actions
Perform updates of controlled documents in a timely manner
Assist in device/drug/cosmetic development process for hand hygiene, oral care, and wet wipes · Evaluate device/drug/cosmetic changes and work with vendors to gather appropriate documentation from vendor

237

QA Specialist Resume Examples & Samples

Review and approve laboratory testing methods, raw material specifications, and standard operating procedures
Generate, inspect and release materials labels
Release/reject raw materials
Generate quality data and reports
Assist in identifying and implementing process improvement opportunities to existing systems
Act as a resource to other departments regarding the implementation of the Quality System
Train/mentor new hires and transfers within the department
Maintain the company’s controlled documents in accordance with cGMP requirements

238

QA Specialist / Engineer Resume Examples & Samples

Coordinates and conducts annual audit of compliance records in advance of public service commission compliance records audits
Conducts special audits of new/revised procedures recently implemented or of newly certified employees
Valid drivers license
With engineering or technical bachelors degree, 2+ years engineering and operations experience in a gas utility, pipeline transmission, or other energy related field
Without bachelors degree, 4+ years engineering and operations experience in a gas utility, pipeline transmission, or other energy related field
Ability to effectively communicate assessment findings
MS Excel - basic proficiency

239

Customer Service QA Specialist Resume Examples & Samples

Oversee all aspects of quality assurance including servicemail file monitoring, call monitoring, evaluation and calibration scoring
Provide coaching, training and development to all contact centre agents
Responsible for scheduling, facilitation and documentation of regular continuous improvement meetings
Provides feedback to Customer Service Manager by monitoring calls; conducting help sessions

240

QA Specialist, Raw Materials Resume Examples & Samples

Review and Disposition of raw material lot files per BioMarin SOPs
Enter raw material lot disposition in LIMS and other databases, as applicable
Maintain electronic status control for cGMP raw materials
Understand the Materials Management and QC raw materials procedures to ensure raw material lot files are compliant with these systems
Provide QA verification of transfer of FBDS from Manufacturing to Quarantine storage
Perform QA approval of OWK pre-weight kits
Perform QA inspection of primary packaging components
Provide QA support to other QA raw materials activities: BioMarin reserve sample program, in-house label production, control of rejected materials, and in-process materials returned from contract sites
0-4 years of directly related experience in a GMP Quality or Manufacturing environment
Working knowledge of process and desktop computers
Experience with Trackwise, Oracle EBS, and/or Labware LIMS is desired but not required

241

Senior QA Specialist Resume Examples & Samples

Closing complaints that have been investigated in the system
Will directly communicate with patients/customers
Someone with combination products experience
Handling surveillance process, product Quality complaints, and CAPA
Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including
MS or Bachelor’s degree in a relevant scientific/engineering discipline with at least 5 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing related experience
The Senior Specialist will be strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality riskbased recommendations
Strong working knowledge of electronic data management systems (e.g. TrackWise and Master Control)
Strong working knowledge of Microsoft Office applications (e.g. Word, Excel, Power Point)
Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs
Complaints handling experience
Combination product background- device and drugs/biologics: they can have both but device background is more preferred
Commercial complaints experience

242

Assistive Technology QA Specialist Resume Examples & Samples

Bachelor’s degree desired
1-2 years experience in a quality assurance role or 3-5 years experience in a technical support role required
Able to independently conduct research on technical capabilities and use that research to identify potential risks to quality or security of assessment content
Capable of independently making effective recommendations to product development and delivery teams on best practices for setup and integration of assistive technology and applications with Pearson products
Functional knowledge of disability categories and the accessible materials and assistive technologies needed to support people with diverse needs is preferred
Ability to effectively create and deliver interactive training with limited advanced notice
Ability to create and maintain accessible documentation for assigned areas of responsibility that are useful in meaningful ways to diverse populations
Demonstrated ability to manage multiple, conflicting priorities in a deadline driven environment
Some evening and weekend hours will be required for this position
Demonstrated ability to leverage free training resources and to initiate and manage the acquisition of new skills as needed to meet job requirements
Functional knowledge of the education industry and/or assessment background desirable

243

RA & QA Specialist Resume Examples & Samples

BA in science, engineering, medical, law, etc
Min 3 yrs of RA experiences in healthcare industry
Better to have relevant experience of Government officials
Better if fluent in English

244

QA Specialist Resume Examples & Samples

Ensuring quality of operations and data being produced in the laboratories by performing data review, auditing laboratories, investigation/corrective action follow-up, and reviewing written procedures
Ensuring laboratory adherence to government regulations and client requirements
Understanding basics of technical procedures; identifying problems and suggesting solutions
Maintaining knowledge of current regulations and quality policy requirements
Perform Sample Unpacking, Entry and Receiving Functions
Administer and manage stability studies
Perform review and approval of SOP's
Review and approve exceptions
Administer document control systems
Administer CAPA system
Administer training records systems
Perform GMP/GLP training
Administer archiving system
Manage GLP studies
Prepare SOP's and forms
Apply other applicable regulations based on assignment, such as GLP
Perform data review (analytical, validation, investigations), review for compliance and identify issues
Review quality control (QC) data and nonconformance issues
Investigate and document quality assurance (QA), method, and regulatory deficiencies within the lab
Perform all QA functions in compliance with quality policy and regulatory requirements
Due to the size of the site employees are required to flex into positions and activities outside their normally assigned duties as workload requires and as trained. These activities require working in all departments including QA, microbiology, chemistry, and general support for laboratory operations
Planning, organization, and work management (multitasking) and follow-up skills; quality orientation and attention to detail
Good technical skills, including the ability to understand analytical methods without actually performing them
Computer skills including word processing, spreadsheets, and database
Bachelor's degree in chemistry or related science
Previous related laboratory or QA experience

245

QA Specialist Resume Examples & Samples

Perform System Administration actions for the GXP LMS
Record training related information into MC, including curriculum updates
Conduct New Hire training for UT and subsidiaries
Perform specific Quality related training. Drives curriculum updates
Support validation activities with supervision
Train users on the LMS
Assists in the maintenance of GXP Training and LMS SOPs
Schedule and coordinate training activities
Collect training records and check for accuracy and completeness
Maintains training records
Must be adept at learning to use data base type computer systems, specifically LMS and EDMS
Proficient in Microsoft Office (Word, Excel, PowerPoint and Outlook). Visio is a plus
Must be able to effectively communicate with users and present information in groups during training
Must have strong attention to detail and be able to multitask

246

QA Specialist Resume Examples & Samples

Working as a part of global and diversified team to test changes to the application
Create test plans based on requirements provided by the development team
Run tests on the application using UIs and spreadsheets
Communicate the results of tests and analysis back to the development team
Capture and report any defects throughout test execution
Provide regression scripts into automation functions and options
Communicate with stakeholders
Quality Assurance & Testing background
Great analytical and problem solving skills
Automated Testing experience (nUnit)
Knowledge of C# coding (understanding and developing the code)
Continuous Integration / build systems’ knowledge (TeamCity SVN,)
Experience of using JIRA or Quality Centre (or equivalent tools)
Non-functional testing experience

247

Revenue Cycle Trainer & QA Specialist Resume Examples & Samples

Develops and maintains detailed, step-by-step where indicated, training materials, both paper and electronic for the Hospital Revenue Cycle team. (20%)
Conducts initial and subsequent new employee or new-to-role training for the Hospital Revenue Cycle team. (20%)
Develops and maintains reporting that will identify deviations in standardized processes and distribute to stakeholders accordingly. (20%)
Maintains a working knowledge of changes to CMS/State billing guidelines or contract-specific payer guidelines to adjust training materials as required. (20%)
Develops manager-level audit materials that may be used to determine the level of procedural compliance by members of the Hospital Revenue Cycle team. (10%)
Prepares and conducts periodic desk-audits as requested by management. (10%)

248

QA Specialist Resume Examples & Samples

A high level of personal accountability, integrity and responsibility
Excellent organizational and time-management skills
Experience in high-throughput, fast-paced environments
Prior clinical molecular laboratory experience is a plus

249

RA / QA Specialist Resume Examples & Samples

Review of documentation generated during product development against current Design Control Process and regulatory requirements
Create and maintain the Risk Management Documentation for new and existing products
Support product and project managers as well as wider organization to meet product regulatory requirements for product registrations to support product launches
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Write or update standard operating procedures to ensure that they reflect current regulatory requirements
Identify relevant guidance documents, or consensus standards and provide interpretive assistance
Support creation of technical files for new products and implement updates for changes to existing products
Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved
Minimum of two year experience in RA/QA within medical device or pharmaceutical industry
Experience with ISO 13485, FDA GMP and Canadian Medical Devices Regulations
Experience with support of cross functional new product development from RAQA perspective including risk management, review of technical files, new product approval and registration
Ability to effectively communicate to all levels within the organization and influence change outside of the local span of control
The ability to adapt in an environment of change, uncertainty, and ambiguity; Can pragmatically make decisions in a timely fashion, especially when there is not a clear path
3-5 year experience working in medical device / IVD industry
3 year experience in preparing and submitting dossiers for class I and class II devices according to global product requirements
Experience as internal auditor with required detailed understanding of the IS013485/ FDA standards

250

QA Specialist Resume Examples & Samples

Prepare and and review batch records, procedures, specifications, validation documentation, and reports
Contribute to the improvement of Quality Management System and ensure compliance with all internal and external regulations
Evaluate non-conformances, perform root cause analysis, investigations, and CAPAs

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