Quality Assurance Associate Resume Samples

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K Ondricka

Kennedy

Ondricka

41207 Kemmer Row

San Francisco

+1 (555) 934 2176

41207 Kemmer Row

San Francisco

Phone

p +1 (555) 934 2176

Experience Experience

New York, NY

Quality Assurance Associate

New York, NY

Witting Group

New York, NY

Quality Assurance Associate

Assist in the design and implementation of a Regulatory Reporting QA Testing Plan covering Trade and Transaction Reporting. This will include the designing, coding and deployment of QA tests
Review and make recommendations to improve the Testing Plan
Assist in driving remediation of findings to improve overall controls environment; Communication of the purpose and scope of QA Testing Plan to wider stakeholder community and
Document QA testing activities and output to Governance Forums
Assist in the co-ordination of all Operations and other stakeholders across Product and Regulatory regimes
Record and assist in the management of QA issues and escalate where necessary
Coordinate testing activities across multiple teams and environments

Boston, MA

Gmp, Quality Assurance Associate

Boston, MA

Rodriguez, Hackett and Upton

Boston, MA

Gmp, Quality Assurance Associate

Assist Quality management in implementing and enhancing new and existing quality systems
Assist in managing quality-related matters during internal/external inspections
Assist in managing quality related matters during inspections, and support maintenance of inspection ready programs
Develop collaborative relationships with operational personnel and be a resource for them regarding questions on all GMP quality systems
Learn about auditing and participate in audits with the Lead Auditor
Working knowledge of electronic databases
Working knowledge of GLP, GMP, GTP

present

Dallas, TX

Senior Quality Assurance Associate

Dallas, TX

Kuphal Inc

present

Dallas, TX

Senior Quality Assurance Associate

present

Perform routine employee training file audits, prepare reports for respective department heads, and work with area management to resolve findings / issues
Assist with developing, revising, and reviewing SOPs. Perform SOP revision training, when necessary
Perform internal audits of Ionis’ cGMP operations and perform external audits of Ionis’ suppliers and contractors, as necessary
Performs such individual assignments as management may direct
Perform internal audits of Ionis’ cGMP operations and perform external audits of Ionis’ suppliers and software vendors, as assigned
Assisting in establishing and enforcing departmental standards
Participates in and provides leadership for projects as designated by upper management

Education Education

Bachelor’s Degree in Business

Brigham Young University

Bachelor’s Degree in Business

Skills Skills

Basic computer skills and ability to learn and become proficient with appropriate software
Having sufficient knowledge and skill to be able to use computers and Quality database systems
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
Ability to work with supervision and demonstrate good decision making skills
Demonstrate high attention to detail, with excellent written and spoken communication skills
Technical/Software tools used: Outlook, Lotus , Training database, Excel files, web-x, great working knowledge of Microsoft databases
Basic ability to use MS Power Point and navigate MS Access
Good work ethic, dependable, punctual, and flexible
Strong attention to detail
Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others

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AML Quality Assurance Associate Resume Examples & Samples

Strong leadership and execution ability
Report writing experience in the context of audits or desk/ themed reviews
Ability to work independently as well as part of a team
Must be able to work well under pressure and to tight deadlines

Quality Assurance Associate Resume Examples & Samples

Coordinate and manage key stakeholders requests and requirements
Assist in driving remediation of findings to improve overall controls environment; Communication of the purpose and scope of QA Testing Plan to wider stakeholder community and
Document QA testing activities and output to Governance Forums
Assist in the co-ordination of all Operations and other stakeholders across Product and Regulatory regimes
Manage QA deliverables in line with the project plan
Record and assist in the management of QA issues and escalate where necessary

Quality Assurance Associate Resume Examples & Samples

5 plus years in pharmaceuticals
Experience with ISOs, SOPs
FDA experience
Medical Devices experience

Ccb Risk Mortgage Banking Quality Assurance Associate Resume Examples & Samples

Must possess strong analytical and problem solving skills to be used in operational planning and evaluation, and interpretation of compliance information
Strong communication, presentation, project management and leadership skills required with the ability to present complex and sensitive issues to senior management in a persuasive manner
Highest level of professionalism, self-motivation and sense of urgency
Proven ability to build strong partnerships with key stakeholders, desire to learn quickly, be flexible and think strategically

Quality Assurance Associate Resume Examples & Samples

XML, XSLT, XLST2, DTD
Windows Server Platforms
Publishing Experience will be added advantage
Knowledge of Java will be added advantage
Is a role model to peers through professional conduct, integrity and attainment of results
Collaboration – build strong relationships that ensure the attainment of your objectives through the BDMs, RMs and RDs
Commercial ability – understands and utilizes economic, financial, and industry data to understand the customers’ business, accurately diagnose business strengths and weaknesses, identify key issues, and develop solutions that address needs
Communicates with impact – expresses thoughts and ideas in a clear, succinct, and compelling manner in both individual and group situations; adjusts language to capture the attention of the audience
Customer orientation – cultivates and maintains strategic customer relationships ensuring that the customer perspective is the driving force behind solutions that are offered
Driving execution – translates strategy and planning into operational reality. Collaborate with product specialists and others to effectively deliver solutions to customers
Effective problem solving – undertakes comprehensive analysis of problems to assess most effective solutions and enlisting support of others to ensure problems are adequately solved
High levels of tenacity and EI (emotional intelligence) – pursue everything with energy, drive, agility and a need to deliver in the face of resistance or pushback. Identify alternative approaches to achieve the desired result when unsuccessful
Negotiation – win the trust and respect of others, both internally and externally, to deliver outcomes that do not damage relationships while remaining direct and forceful as well as diplomatic
Team work – in all work groups, participate enthusiastically, share your unique perspective, remain open to the views of others and collectively resolve internal and customer issues

Quality Assurance Associate Resume Examples & Samples

Write test cases
For a given application and also lead the test effort for an entire application, if needed
Write SQL queries and verify test results in database
Create/Execute Test Metrics using ALM
Review and understand data flow across multiple systems

Quality Assurance Associate Resume Examples & Samples

Prior GMP experience is a mandatory requirement
Prior experience in Metrics compilation
Experience with SAP and TrackWise

Quality Assurance Associate Resume Examples & Samples

B.Sc Computer Science/GNIIT/B.Tech/ BE
XML, Publishing Knowledge etc
Minimum of 0-1 Years of experience required with:-
Ability to learn and grow – commits to and actively works at continually improving yourself. Deploy your strengths for the advantage of others and in recognition of your limitations, seek guidance and development opportunities

Ccb-risk-mortgage Banking Quality Assurance Associate Resume Examples & Samples

The Branch Quality Assurance (BQA) Analyst is responsible for determining an monitoring the level of quality maintained by originating offices and helping them improve their level of performance
The BQA Analyst will be responsible for assessing the level of quality and adequacy of controls surrounding mortgage loan originations and working with management to develop solutions for any issues identified
The BQA Analyst function addresses all risks including fraud, operational, reputational, and financial risk
Through the review process, the Analyst identifies gaps in processes, controls, performance, and compliance with established policy
The BQA Analyst is responsible for additional projects and leading various initiatives to continually maintain and improve the BQA Review program
3+ years audit/quality control experience with ability to evaluate key risk factors surrounding the mortgage loan origination process
Solid knowledge in audit theory and methodolity
3+ years mortgage banking experience, with preference for experience in loan originations (either in a line-of-business or review capacity)
Independent and Self Sufficient worker
Must be conversant with federal laws and regulations impacting mortgage banking
The BQA Analyst needs to be detail oriented and be an exceptional communicator
Must possess leadership abilities, and have strong written communication abilities to convey issues concisely and succinctly to an extremmely dissimilar distribution
Accuracy and thorough are critical as audits must withstand external audit scrutiny
Must be able to travel up to 10%

Quality Assurance, Associate Resume Examples & Samples

Interact with Product Manager and customers to develop business level customer facing tests using Cucumber, Selenium or similar tools
Full test lifecycle oversight, organising unit testing for instance feedback and continuous integration, and larger functional cycles for integration and deployment testing
Java development experience with solid understanding of programming principles
Experience working in Scrum teams and sprints
Understanding use cases, business rules
Experience in defining specifications by example and conditions of satisfaction
Reporting metrics
Financial Product Knowledge (e.g., Equity, Listed Options, Structured Products, Fixed Income, etc.) a plus

Ccb-mortgage Risk Quality Assurance Associate Resume Examples & Samples

Coverage Analysis - Mapping all investor requirements to current OQAT Quality Assurance Policy, Procedures and OQAT Questionnaires to ensure all components are met and appropriately documented using Chase preferred methodology
Ability to understand and comprehend origination policies, processes, and to effectively identify if it is applicable, what revisions may be needed and provide your summary findings concisely to your Business Partners. Responsible for executing all applicable changes timely
The Quality Assurance Associate may review performing and non-performing real estate loans to analyze Capacity, Capital, Character, Condition, Compliance, and Loan Integrity, including ensuring loans meet program and product specifications. The ideal candidate must understand all loan products (Agency, Non-Agency, Government, USDA and Equity), and possess strong Underwriting and Regulatory Compliance knowledge
Perform quality control reviews of OQAT test work when applicable
Assist as necessary with maintenance of testing procedures to ensure most recent version is up to date with OQAT policies and processes
Ability to understand and comprehend originations policies, processes, and technologies to effectively identify gaps in QA Questionnaires, Program Manual or Procedures
Ability to effectively communicate autonomously and concisely with business partners and team members
Required to submit Change Requests to address all Coverage Analysis requirements to QA Questionnaires, Sampling, Reporting, etc
Ability to structure job aids for QA Analyst and effectively utilized to communicate changes to QA Questionnaires
Minimum of five (5) years Senior Underwriting experience required (FHA DE, VA LAPP / SAR and RHS)
Minimum of five (5) years first mortgage underwriting experience within most recent seven (7) years
Strong knowledge of Automated Underwriting Systems (DU, LP, GUS and TOTAL)
Strong first mortgage (prime) underwriting and regulatory compliance knowledge
Bachelor’s degree in business, finance, or related field; or equivalent work experience required
Demonstrate proficiency in accessing multiple systems, platforms and applications

Quality Assurance Associate Resume Examples & Samples

Assist with test plan development
Detailed test case development, documentation, and execution
Test environment/data setup or coordination
Test automation execution and maintenance
Participation in requirement walkthroughs or User Story Refinement
Collaborate with Development and Business partners
Defect detection, analysis and documentation through to closure
Previous Software testing experience is a plus
Self-motivated, independent worker; ability to be a team player
Able to maintain a positive and professional attitude when working with complex issues
Ability to develop effective internal/external working relationships
Ability to work in fast paced environment and learn new technologies quickly
Familiarity with the following technologies, tools or practices is a plus: Agile/SCRUM, Dev Ops/Continuous Integration, Windows, IBM Lotus Notes, MS Office suite, Test Automation Tools (i.e. HP UFT, Selenium), HP Quality Center/ALM, IBM Mainframe platform, file/data compare tools

Quality Assurance Associate Resume Examples & Samples

Knowledge of regulatory requirements /cGMP/ ICH
Microsoft Office/Suite (Excel, Word, PowerPoint, etc.)
Knowledge of product complaints processing, stability protocols, and manufacturing activities

Cib-china Operation Quality Assurance Associate Resume Examples & Samples

Responsible for various ops control effectiveness and regulatory reporting quality assurance tests
Lead risk reviews and self-assessments required by local regulators
Perform branch onsite ops control and regulatory reporting reviews as well as gap analysis on those areas
Review ops SOPs and provide enhancement comment if control gap identified
Control reviews on selected high risk processes
Perform quality assurance testing on regulatory reporting
Oversight on all operation risk control issues and follow up remediation action
Assist senior management in establishing and maintaining strong regulatory relationships with PBOC, CBRC and other regulators
Provide KPI/KRI to senior management and control improvement suggestions
Provide risk and control awareness training to Ops staff
College graduate or above
At least 6 years of working experiences in banking/operations
Good ability of internal controls and compliance in local regulations on operations area
Be able to work independently as well as being a team-player
Ability to communicate proactively and openly with internal and external business partners locally and remotely
Good organization and time management skills with ability to handle multiple tasks with tight timeline
Fluent written and oral communication skills in English and Mandarin

CIB F&BM Quality Assurance Associate Resume Examples & Samples

Assisting in the creation of process maps which outline the LOBs being reviewed and help form the scope of our testing
Performing ad-hoc testing outside of our “scheduled reviews” and occasionally assisting external reporting team around quarter-end
Basic understanding of securities and derivatives products
Comfort liaising with business and risk managers
Ability to build and maintain partnerships within the various product aligned businesses and across other corporate financial, treasury, and accounting groups
Existing relationships and networks within JPMorgan IB community an advantage
Ability to understand business drivers and requirements and influence middle and front office partners to deliver solutions to business issues and problems
Strong analytical skills: Ability to quickly understand workings of a complex processing system and general ledger systems across the infrastructure and their interrelationships and dependencies

Quality Assurance Associate Resume Examples & Samples

Minimize monetary loss from defective merchandise including apparel, shoes, accessories, and soft goods received from vendors
Identify the most effective defect recovery process for each item – RA, Sellable Defect, Donate, Discard
Preserve and reinforce existing relationships with vendors, develop and maintain relationships with new vendors
Bachelors’ Degree in fashion preferred or sufficient experience working in a production or QA/QC environment
2-3 years minimum working in a production or QA/QC environment required
Microsoft Office Suite required
Technical fashion knowledge preferred

Field Sales Quality Assurance Associate Resume Examples & Samples

Liaise with various internal and external teams to audit Sales Reps
Lead Kiosk audits (i.e. compliance to dress code, Bell collateral, etc.)
Driver’s licence and vehicle
Strong leadership, training and coaching skills
Very autonomous, but works well in a team environment
Strong and confident independent thinker
Exceptional project management and organizational skills
Demonstrated ability to develop an environment which inspires employee involvement and teamwork
PC Proficient – MS Office, Windows environment
Strong interpersonal skills – someone who enjoys having fun in a fast paced and dynamic environment
Strong knowledge of Bell’s ordering, installation and billing systems and processes

Senior Quality Assurance Associate Resume Examples & Samples

A minimum of a Bachelor’s Degree (or equivalent degree) is required
A degree focused in Biology, Biochemistry, Microbiology or Chemistry is preferred
A minimum of 4 years of experience in Quality Assurance is required
Experience in the medical device, consumer goods, biopharmaceutical, and/or pharmaceutical industry is required
Advanced knowledge and experience with regulatory requirements, policies and guidelines is required
Significant experience with Quality document reviews and regulatory inspection processes is preferred
Advanced knowledge of quality systems (ETS, etc.) and Investigation tools is required
General cGMP knowledge is required
Familiarity with 21CFR 210, 211, Part 11, and Q7A is required
Advanced validation experience, including: cleaning, process, steam sterilization, computer, equipment, calibration practices/methodology, method validations and transfers, change control practices/methodology is preferred. Familiarity with HVAC systems, high purity water systems, QC testing, Biologics Manufacturing is strongly preferred
This position will be located in Malvern, PA and may require up to 5% travelQuality Assurance

Quality Assurance Associate Resume Examples & Samples

Excellent communication skills and superb attention to detail
Excellent inter-personal skills and customer service focus is required
Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB
Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice

Senior Quality Assurance Associate Resume Examples & Samples

Represent the Quality Assurance Unit and interact with multiple departments to provide GLP guidance in an effective manner
Become intimately familiar with company Standard Operating Procedures (SOPs), FDA and MHLW regulations, OECD guidelines, and other appropriate regulations and guidelines. Also be familiar with any sponsor SOPs that may apply to studies
Review validation, sample analysis, and associated data, and reports for compliance to GLP regulations and guidelines, the study protocol/plan, SOPs, and Bioanalytical Procedures (BPs)
Determine that deviations from approved study protocols/plans or SOPs and BPs were made with authorization and documentation
Assure compliance with GLP regulations and guidelines and company procedures (SOPs and BPs)
Submit to the Study Director and the Study Facility Management periodic written reports of each study, noting any problems or corrective actions taken
Assist with developing, revising, and reviewing SOPs. Perform SOP revision training, when necessary
Take the initiative on any QA related issues with regards to GLP compliance
Periodically review training records of employees
If necessary, interact with the Sponsor QA team during visits to the laboratory as well as prepare written correspondence regarding QA audits and compliance audit findings
Perform periodic facility inspections to ensure laboratory maintains compliance
Perform study phase (in-process) inspections to ensure compliance and integrity of the study
Maintain the Master Schedule
Support of other QA functions as needed
5+ years of relevant experience in QA, QC, Regulatory Affairs, or within a GXP (GCP, GLP, GMP) environment

Quality Assurance Associate Resume Examples & Samples

Learn about all aspects of the SDLC in an agile environment as well as QA best practices
Play a major role to improve quality, functionality, reliability and usability of software products
Analyze business requirements to develop and execute comprehensive test plan
Perform thorough test case execution and defect reporting
Bachelor’s Degree in Computer Science or similarly technical/quantitative field or
Bachelor's Degree in Business, Information Systems, or Finance with a proven interest and/or experience in technology, SDLC or Fin-tech space
Experience with C#, PowerShell scripting and SSRS reporting is a plus
Ability to excel in cross functional team environment
Self-motivated and good team player

Interviewing Quality Assurance Associate Resume Examples & Samples

Do you understand the importance of data integrity and accurate research results?
Are you a caring individual who enjoys providing recognition and encouragement to others?
Do you have a talent for listening and the ability to communicate easily with others?
Are you a perfectionist with an eye for detail?
Are you a highly responsible person?
Do others rely on you to get the job done right?

Quality Assurance Associate Resume Examples & Samples

Prepare such forms, documentation or calculations as may be required from the Quality Control Laboratory in the manufacturing process and quality assurance program
Maintain an accurate, legible and current laboratory notebook recording all tests or results of experiments, which are not otherwise recorded on approved forms
Maintain the Quality Control Laboratory and laboratory equipment and instrumentation in an orderly and clean condition performing any maintenance, calibration and repair of such equipment and instrumentation as may be required
Maintain the product retention room in a clean and orderly condition
Perform In-Process QC testing and maintain the documentation on all materials requiring such testing as needed to support the production facility
Review, approval, and/or dispose of non-conformity reports associated with the manufacturing operation
Review production device history records for completeness to facilitate the release of finished product
Assist with the review of batch documentation provided by contract packagers or manufacturers of distribution items
At least one year of relevant experience
Bachelor's degree (B. A.) from four-year college or university

Quality Assurance Associate Resume Examples & Samples

Development, implementation and maintenance of Stryker South Pacific Quality System
Liaise with relevant SSP and Corporate process owners regarding development & implementing process requirements
Monitor site implementation of the Quality System requirements, and provide mentoring, assistance and training to process representatives
Develop and / or revise QS process procedures to incorporate appropriate regulatory and corporate requirements
Monitor the quality standard activity and ensure Management is informed in a timely manner of changes/trends that could affect SSP’s Quality System

Quality Assurance Associate Resume Examples & Samples

Check overall product quality and measure product utilizing predetermined points of measurement and comparing against standards and spec sheets
Fit apparel on body form to confirm fit, identify inconsistencies and make fit recommendation
Enter measurements, fit recommendation and descriptive product details into PDP
Systemically move product that has been checked to the next location
Enter PID details into QC Product Tracking document for metric tracking

Quality Assurance Associate Resume Examples & Samples

A High-school diploma or GED is required
A Bachelor’s Degree is preferred
Biology or other Life Science degree is preferred
At least 1 year of work experience in a GMP (Good Manufacturing Practice) facility is preferred
At least 1 year of experience working with and/or auditing batch records is preferred
At least 1 year of experience working with Standard Operating Procedures and associated documentation within a regulated industry is preferred
At least 1 year of technical writing experience is preferred
At least 1 year of experience performing visual inspections for cleanliness is preferred
At least 1 year of experience performing inspections for process conformance and complete documentation is preferred
Flexibility to work a non-traditional shift is required
Microsoft Office Suite proficiency is preferred; this includes Microsoft Outlook, Word and Excel
Lean Six Sigma, ASQ certification or other related professional certification is preferred

Quality Assurance Associate Resume Examples & Samples

Review assay data, protocols, reports, technical specifications, certificates of analysis, RIRs, Cell banking Production Records for compliance requirements
Review lab records, batch records, SOPs and other documents for auditing requirements
Audit routine assays
Conduct Systems Inspections
Interact with other departments to ensure compliance with internal procedures and FDA regulations
Demonstrate verifiable turnaround times
Participate in projects, as assigned
Zero to one year experience in Quality Assurance or related field within a GXP environment
Introductory to working knowledge of FDA regulations (cGMP, GLP, Part 11)
Working knowledge of good documentation practices
Good oral, written communication and interpersonal skills required

Quality Assurance Associate Resume Examples & Samples

Assist in the development of Standard Operating Procedures in order to maintain quality systems in line with current regulations, BMS directives, and industry standards
Lead tagging efforts of released direct materials for production
Participate in company project teams
Scan/Submit completed documents for document system archival
Author Standard Operating procedures, Forms, and other Operations related documentation
Assist with monitor and inspect the production facility during product manufacture and notify QA and other departmental management of potential quality issues
Participate in corporate audits and FDA or other health authority inspections (as needed)
Assist in the preparations of periodic trend reports of quality data such as deviation, CAPA, Quality Council data, Other duties as requested
Bachelor's Degree in scientific or technical discipline plus
1603728

Quality Assurance Associate Resume Examples & Samples

Performs Quality Assurance audits of the entire FAO DOL operation
Monitors and audits department operating procedures
Reviews weekly statistics and record data necessary for analysis of key processing areas
Generates daily, weekly, and other periodic reports
Compiles monthly/weekly QC sample data required by the client
Provide support for individual department quality control processes
Maintains Quality Assurance Procedures manual
Supports departmental staff training
Analyze quality control data and make recommendations to departments based on findings
Good organizational skills and decision-making ability
Must be able to work independently and multitask
Experience using Microsoft Office applications
Must have the ability to analyze data, determine needs, implement solutions and track results
Must be prompt and dependable
Previous quality control or claims processing experience preferred

Transaction Quality Assurance Associate Resume Examples & Samples

Minimum of 1 year work experience in a BPO / Call Center Industry catering US Healthcare services
Bachelor’s Degree/Associate Diploma Holder
Wide knowledge on Healthcare Revenue Cycle
Can work with minimum supervision

Senior Quality Assurance Associate Engineer Month Fixed Term Contract Resume Examples & Samples

Participate in the creation and approval of complete, unambiguous, and measurable design outputs
Review and approve specifications, including those for raw materials, intermediate products and finished products
To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485
Holds a professional scientific qualification e.g. B.Sc. Hons Electro-Mechanical / Electrical/ Manufacturing Engineering or equivalent science or chemistry based degree
Or a HNC or equivalent qualification with a substantial amount of experience in a similar Quality, Compliance or Regulatory related role in relation to product development within a Medical Devices and / or Medicinal Product / Healthcare / Pharmaceutical environment
Position requires the individual to demonstrate a good understanding of QA and have substantial relevant experience within this type of area to be able to lead aspects of this project
The jobholder will act as a team player in the organisation by being aware of the scope, responsibility and authority of his/her functions and activities and their impact on product and service quality as they relate to applicable laws, regulations and standards
The role serves as an example of quality excellence, applies technical rigour in problem solving and analysis, mentors and teaches less experienced quality staff and maintains currency of all necessary legislation, regulation and standards
Successful individual will be able to work independently and be comfortable not being micro-management but also work collaboratively across different areas

Quality Assurance Associate Resume Examples & Samples

Participate in the creation and/or revision of relevant Quality standards. Will support the rollout of quality processes for the site
Assist with preparation activities for regulatory authority inspections to enable inspection readiness at the site
Provide quality and compliance training to R&D personnel. May contribute to training content
Develop Quality skills to provide support for customers and for implementation of legal regulatory quality requirements. Seek continuous technical quality improvements
Assist QA team members with maintenance of Quality (Q) Agreements in support of Elanco R&D team’s activities. Assist with the initiation, review, and renewal of Q Agreements with assigned Quality team members. May maintain some Q Agreements independently
Anticipate customer (internal and external) needs and handle non-standard requests
Responsible for planning and conducting GXP oversight activities at the site, and at Contract Research Organizations: GRP, GCP or GLP study protocol, in-life and data/reports reviews/audits; site process self-inspections; and GRP, GMP, GLP or GCP qualification and oversight activities for work completed at third parties. Issues inspection reports, and reviews and approves responses and corrective actions. Proficient in one or more GXP areas, and may be seeking skills in other GXP areas
Completes release of investigational batches (drug substance/API, Drug product, vaccines), seed and cell lines, and other development materials as per Elanco R&D Quality System requirements.Proficient in one or more types of material to release
Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies
Perform any other duties or serve in such other capacity as may be determined by Company management
Vaccine/animal health development experience, with R&D-related Quality Assurance
Ability to operate in a business focused R&D Quality organization recognized as a collaborator and partner to both the R&D organization and CRO business partners
Knowledge in one of the following: GCP (VICH GL9), GMP, or GLP compliance in one or more global regulatory requirements (USDA, CFIA, MHRA/VMD, EMA)
Knowledge of PC tools including all MS Office applications and Internet
May lead small to medium scale projects with minimum to moderate risks
Knowledge of business process and the ability to work within the general business hierarchy
Aware of risk-assessment methodologies, and project organization
Ability to effectively work with teams
Ability to set priorities and manage multiple tasks

Quality Assurance Associate Resume Examples & Samples

Bachelor's degree in Business, Quality Assurance, or similiar discipline
A minimum of 1 years regulated GMP industry and/or QA experience
Experience with DCA and LMS, SharePoint, and Trackwise a plus
Strong attention to detail and decision making skills
Strong analytical skills and experience with data analysis
Ability to work independently and keep up with rapid changes in priorities; to work on multiple projects without loss of efficiency and move to new projects with relative ease
Ability to gather information from a variety of sources and analyze all data to provide management with comprehensive reports
Strong verbal and written communication skills and interpersonal skills
High level of PC competence (proficiency of all software used by the company including MS Project, MS Access, MS Excel, MS Word, IE and Netscape Navigator) and an understanding of computer and database logic
Requires independent judgment and decision making in conducting audits and recommending a course of action for discrepancy resolution
Knowledge of medical and/or clinical trial terminology
Relational database concepts

Senior Quality Assurance Associate Resume Examples & Samples

Ensure compliance of Ionis’ change control and validation program with respect to Ionis’ QMS, SOPs and applicable domestic / international regulatory requirements. Perform activities that support execution, maintenance and oversight of equipment, facility, and utility qualification, computer system validation (CSV), cleaning validation and change control
Review IQ/OQ/PQ protocols, quality control data, and other GMP records (for GDP and technical conformance to protocols, internal methods and procedures, and material specifications)
Provide quality oversight of change control and validation activities (includes execution or re-execution of equipment, laboratory instrument, facility, and utility qualifications, cleaning/process and software validations in accordance with Ionis' QMS and validation master plan
Resolve moderately complex quality events and issues (e.g. deviations, investigations, Out-of-Trend investigations, or any others as appropriate)
Manage contractor and employee training files and electronic or paper-based training records (e.g. CVs / resumes, Job Descriptions, Analytical Training Forms, Group Training Records, etc.)
Perform routine employee training file audits, prepare reports for respective department heads, and work with area management to resolve findings / issues
Perform internal audits of Ionis’ cGMP operations and perform external audits of Ionis’ suppliers and software vendors, as assigned
Develop and implement enhancements to Ionis’ Quality System procedures, as assigned
Support external regulatory or partner cGMP audits, as assigned

Senior Quality Assurance Associate Resume Examples & Samples

Ensure the compliance of Ionis’ manufacturing and testing activities with respect to Ionis’ procedures as well as FDA, EU, ICH, and other regulatory expectations and requirements
Coordinate and/or perform collection and processing of samples for environmental monitoring and water testing; manage the receipt and review of test results; prepare monthly, quarterly, and annual trend reports as required per relevant procedures
Perform batch record review and lot disposition activities for raw/starting materials, reagents, intermediates, and drug substance
Review analytical data packages associated with stability testing for drug substance and drug product. Recognize and communicate trends associated with the data over time
Resolve moderately complex investigations and events as directed by area management
Review SOPs, logbooks, and other documentation related to daily QA activities
Perform internal audits of Ionis’ cGMP operations and perform external audits of Ionis’ suppliers and contractors, as necessary
Provide support for external regulatory or partner GMP audits
Develop and implement enhancements to Ionis’ quality system procedures

Quality Assurance Associate Resume Examples & Samples

Partner with Product Development, Regulatory Affairs, Clinical Research, Facilities and Manufacturing to meet clinical project and product needs
Compile, track quality metrics for critical quality attributes and report to management on a quarterly basis (i.e., Lot disposition, Deviations, CAPA, Change Control, OOS, and audits)
Working with QA Managers, maintain the QA databases for Product Genealogy, Deviations/CAPA, Change Controls and Audits
Support training events related to Intarcia quality procedures, cGMP regulations and guidelines
A minimum Bachelor’s degree in a scientific discipline is required
Strong working knowledge of cGMP regulations (for e.g., 21CFR4, 21CFR211, 21CFR820, ISO13485), and ICH guidance’s
Attention to detail in review of GMP records e.g., batch records, specifications, analytical, EM data, CoA etc
Pro-active in identifying opportunities for improvement along with strong problem solving and negotiation skills

Quality Assurance Associate Resume Examples & Samples

Register Technical Product Complaints (TPCs)
Opening TPCs for all SAEs, AEs, other events coming into the AER Argus system workflow
Monitoring complaints for timely follow-up
Work with investigators and contract manufacturers to ensure timely complaint investigations
Send “30 day” updates on complaint status to customers
Prepare customer letters, manage letter translations, reviews and delivery to customers
Perform trending and data analysis for meetings / reports
Provide support for Regulatory authority and customer requests regarding complaints
Provide training on the product complaint process
Identify compliance weaknesses and ensure the implementation of workable solutions
Write/revise/review SOPs/INSs as necessary
As requested
Bachelor’s degree or equivalent in a scientific discipline with a minimum of 5 years’ experience in a pharmaceutical or medical device industry or Master’s Degree with a minimum of 3 years’ experience
Minimum 3 years’ experience in regulated operations
Strong understanding of the FDA QSR regulations, Medical Device Directive, ICH Q7, ISO 13485, and sterilization standards
Ability to exercise independent judgment
Strong data review and technical writing skills
Direct experience with product complaint handling, including investigation and documentation
High-level understanding of scientific approach and analytical thinking of others
Strong communication skills (encompasses verbal, written, interpersonal, listening)
Ability to influence others
High level of attention to detail and accuracy; very observant in order to audit properly
Flexible; ability to adapt to changing priorities
Excellent time management skills (schedules, timelines, task prioritization)
Perform internal and supplier quality audits and facilitate corrective actions
Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner

Quality Assurance Associate Resume Examples & Samples

Review manufacturing, QC, release records, and documentation for medical device and drug substance/drug product
Audit reports and raw data for compliance with protocols, SOPs and regulations, including design verification, stability, aging, sterilization, and validation
Participate in product development project teams
Perform supplier quality audits and facilitate corrective actions. Interact with suppliers on quality matters
Oversee change control program, including review and approval of change documentation, tracking activities, and verification of effective implementation
Write/revise/review SOPs/INSs, prepare flow charts and other quality documentation, including investigation reports, audit reports, quality metric trend reports, etc
Conduct internal audits/inspections of regulated in-house operations
Provide training and guidance in the areas of government regulations to effected employees
Perform other related duties as required
Minimum 3 years’ experience in GMP operations
Strong understanding of the FDA GMP regulations, Medical Device Directive, ICH Q7, ISO 13485, and sterilization standards
Direct experience with auditing techniques and evidence development

Quality Assurance Associate Resume Examples & Samples

Responsibility for Lack of Effect complaint handling to ensure complaints are processed in compliance with timelines and metrics targets are achieved
Preparing product certifications and providing to customers, arranging meetings, assisting in typing correspondence and preparing presentation material, travel arrangements, documents filing (both electronically and hard copies)
Performing reconciliation activities to ensure all adverse events (AE) combined with PQCs are reported to Drug Safety and PQCs combined with AEs are captured in the Complaint handling database
Reviewing reports from other intake organisations to ensure all relevant PQCs are captured
Acting as SOP owner for role allocated SOP's, review, re-write and prepare self-directed on line learning training materials for others to complete, as required to reflect internal/external changes
Other QMS activities as required
Self-identify relevant information and actions and prioritise workload
Excellent interpersonal, collaboration and verbal and written communication skills, self-motivated, clear thinker and organised
Ability to communicate with internal and external customers
Ability to identify ways of streamline processes and take initiative in suggesting new approaches in order to drive continuous improvement
Ability to work to deadlines in order to work to compliance metrics
Degree in pharmacy, chemistry, microbiology or related scientific discipline

Quality Assurance Associate Resume Examples & Samples

Reviews batch templates for new products to be manufactured or repackaged, to ensure alignment with IND/CMC as well as clinical trial protocol, prior to initial use
Reviews batch record documentation for accuracy and completeness according to cGMP to ensure timely release of finished products
Reviews study-specific SOP’s for high-risk products against the clinical trial protocol and other relevant materials, prior to study launch
Performs retrospective quality checks on dispensing for high-risk products and clinical trials with high complexity
Develop and maintain a system for release of raw materials for use in manufacturing processes
Conducts ongoing and targeted audits of operational processes, policies, and procedures to ensure compliance with regulatory requirements and internal SOPs
Documents findings and communicates results with applicable personnel
Assists in coordinating and overseeing operational compliance monitoring activities, including providing subject matter expertise to address/resolve questions
Assists in developing corrective action plans to address compliance deficiencies, minimize violations and prevent systemic compliance issues. Conduct deviation triage and preliminary investigation
The minimum of a Bachelor’s degree in a science-related field and 3 to 5 years of applicable experience or an equivalent combination of education and experience required. Experience should include time as a Quality Assurance Associate, performing batch record reviews, and releasing products for use in clinical trials
Experience with pharmaceuticals is strongly preferred. Previous working experience in a lab is preferred
Demonstrated cGMP knowledge and experience is required
Previous experience implementing Quality Systems (CAPA, Root Cause Analysis, Change Management, Deviations, Inventory Management)
Demonstrated experience of working collaboratively in a team environment is required
Strong analytical skills, detail-oriented
Demonstrated experience meeting critical deadlines; maintaining precision and accuracy and performing under pressure

Imaging Quality & Assurance Associate Resume Examples & Samples

Japanese level 2 or similar, can fluently read, write and have phone call in Japanese
Open-minded, easy-going, reliable, patient, positive working attitude, good sense of responsibility
Strong ability of execution
Be able to analyze & judge independently
No Vision problem
Good Aesthetic judgment, be able to understand the meaning of images displaying; good cognition of product shape and pattern
Customer Obsession
Familiar with Photoshop software at elementary level
Familiar with other MS Office software
Good command of English reading skills
Experienced in QA in an E-commerce company is preferred
Have customer support experience is preferred
Good command of Excel and experience with using Excel as basic analysis tool is preferred
Good command of written English is preferred

KYC Quality Assurance Associate Resume Examples & Samples

Perform ongoing formal testing of completed KYC records to ensure standards are met
Review the quality of completed KYC records using pre-defined test scripts which are based on KYC and Quality Assurance standards
Question and investigate the reliability and integrity of data, the validity of conclusions and the appropriateness of assumptions made (where appropriate)
Present findings via formalized feedback loop process, track and monitor corrections to identified critical defects
Effectively communicate with key points of contact to ensure the fluid sharing of information and feedback across pertinent teams
5+ years of experience with Financial Services industry, AML/BSA, KYC, Sanctions, Compliance, Investigative or Quality Assurance background preferred
Demonstrated experience adhering to controls and compliance standards
Working knowledge of MS office & MS SharePoint

Temporary Call Center Quality Assurance Associate Resume Examples & Samples

Strong knowledge of customer care processes and techniques
Projects positive team image and demonstrated ability to work well in a team environment
Understands and maintains confidentiality of information and results
Requires moderate to intense concentration due to complexity and/or need to meet deadlines, and flexibility to readily adapt to a changing environment
LI-JY1

Quality Assurance Associate Resume Examples & Samples

Functioning knowledge of Microsoft systems including: Word, Excel
Ability to meet deadlines in a fast-paced work environment driven by software systems and processes
Ability to trouble-shoot and make visual quick decisions based on training
Authorized to work in the U.S. without sponsorship
At least 18 years of age
Experience in quality assurance
Experience in tracking data
Ability to multi-task & prioritize, with strong organizational and follow-up skills

Senior Quality Assurance Associate Resume Examples & Samples

Attending and participating in applicable company-sponsored training
Ability to work in group setting and independently; ability to adjust to changing priorities
Excellent attention to detail and orientation toward meticulous work
3+ years relevant experience in areas of Quality Assurance, Inspection, or Auditing
Possesses a strong working knowledge of Good Clinical Practices (GCP), Quality/Regulatory Guidelines, and is competent with quality control procedures including acceptance criteria
Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)

Quality Assurance Associate Resume Examples & Samples

Reporting responsibility for Product Quality Complaint (PQC) to ensure complaints are processed in compliance with timelines and metrics targets are achieved
Acting as SOP owner for role allocated SOP's, review as required to reflect internal/external changes
Other Quality Management System activities as required (nonconformances)
Ability to communicate with internal and external customers (English, Polish)
Working to tight deadlines (ability to work to deadlines in order to work to compliance metrics)
Having sufficient knowledge and skill to be able to use computers and Quality database systems
During studies or up to one year after graduationQuality Assurance

Production Quality Assurance Associate Resume Examples & Samples

Troubleshoots and researches production issues
Verifies file totals prior to processing
Audits calculations after print processing
Performs file verifications to ensure correct number of items have been processed
Verifies necessary postage and inserts are included for outgoing mailings
Ships packages to clients via Courier, USPS, UPS, DHL or FedEx and traces packages as needed
Tracks quality control issues in appropriate computer database(s)
Maintains various records and files
Assists less-experienced peers on issues they are not able to resolve on their own
As needed, may train new clerks
Performs administrative duties, including but not limited to filing and data entry
Proficient in the use of basic office equipment and tools as well as applications specific to discipline
Works well in an environment with firm deadlines; results oriented
Ability to multi-task in a fast-paced environment and adjust schedules to meet deadlines
Ability to work in an organized manner
Team skills, including the ability to establish and maintain effective working relationships with employees, clients and public
Requires the ability to stand for lengthy periods of time and the ability to lift up to 40 pounds
Occasional lifting, standing, walking and bending in a production environment

Quality Assurance Associate Resume Examples & Samples

Represent and interact with multiple departments to provide GLP guidance in an effective manner
Become intimately familiar with company Standard Operating Procedures (SOPs), FDA, OECD, and MLHW regulations, and other appropriate guidelines and regulations. Also be familiar with any sponsor SOPs that may apply to studies
Review validation and project data for compliance to SOPs and Bioanalytical Procedures
Determine that no deviations from approved protocols/plans or Standard Operating Procedures were made without prior authorization and documentation
Assure compliance with GLP regulations and company procedures (SOPs and BPs)
Troubleshoot and take the initiative on any QA-related issues with regards to GLP compliance
Submit to Study Director and/or Study Facility Management periodic written reports of each study, noting any problems or corrective actions taken
Assist with performing study phase (in-process) inspections to ensure compliance and integrity of the study
Assist with maintaining training records of all employees
Assist with performing facility inspections to ensure laboratory maintains compliance
Support all other QA functions as required
Bachelor’s Degree (BA or BS) preferred; equivalent work experience/training considered
2+ years of relevant experience in QA, QC, or in GXP (GCP, GLP, GMP) environment

Quality Assurance Associate Resume Examples & Samples

Quality call monitoring and scoring
Auditing cash receipts for quality and compliance of procedures used
Communicating errors, issues and solutions to leadership
Provide leadership with detailed information regarding monthly quality results
Communicating audit results monthly during the team meetings
Continually evaluates processes and procedures for team
Identify areas requiring training and ensure gaps are completely filled within given time frame
Enhance quality across organization and provide stable performance to customers
Works one-on-one with front line staff to educate and provide the training staff examples of common errors
2 + consecutive years of cash applications and/or commercial collections (preferred)
2+ consecutive year of quality audit experience (preferred)
High level of organizational skills, integrity and accuracy
Strong communication skills with excellent written and verbal communication
Strong attention to detail, analytical and problem solving skills
Excellent interpersonal skills working with internal and external customers
Proficient in Microsoft Office Suite plus proficient in use of Oracle (preferred)
The ability to prioritize workload and meet tight deadlines
Must be a self-starter, able to work independently as well as be part of a team

Quality Assurance Associate Resume Examples & Samples

Working knowledge of US Drug Product GMP requirements and associated guidelines
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
Experience in administration of quality systems for drug product manufacturing and quality control operations
0-2 years’ experience in a Quality Assurance role in the pharmaceutical industry

Quality Assurance Associate nd Shift Resume Examples & Samples

Knowledge, Skills, Education and Experience
Ability to read and write in the English language
Must be detailed oriented

Preferred Banking Client Services Quality Assurance Associate Resume Examples & Samples

Navigate through various client-information based systems (OnBase, TotalPlus, CRB, and Flightpath) to review account documentation as assigned by QA Supervisor and update the QA Database with exceptions as necessary. Additionally, properly communicate outstanding KYC issues to Preferred Bankers. Assignments from QA Supervisor include both new accounts assigned in the QA Review database and supersede changes on existing accounts
Review pending exceptions on a daily basis and clear exceptions in a timely manner. Ensure pending exception notes are kept up to date within the QA
Review Database to ensure Exception Reports are current and accurate at all times. Work with QA Supervisor, when necessary, to resolve all pending items and escalate any outstanding exceptions over 15/20 days
Familiarize and understand the in’s and out’s of Flightpath system for efficient and accurate data entry of KYC information for business, individual, and trust entities. Stay up to date with all Flightpath system changes. Communicate any Flightpath issues/discrepancies to QA Management
Use various Imaging tools when best applicable (Ephesoft Scan, VPD, Outlook Integration, Onbase - all versions, and/or “Drag and Drop”) to image documents received from the Preferred Bankers for New Accounts/Supersede Accounts and uploaded to Onbase accordingly. Be familiar with the scanning, uploading, and keyword process for all Imaging tools to ensure 100% imaging quality (0% reject error rate)
Ensure new accounts are linked properly to existing Signature Card within timely manner to avoid imaging rejects. Be familiar with delinking closed accounts from existing Signature Card to help review closed account report when needed as backup
Remediate any audit exceptions cited by internal audit functions (i.e: QCM reporting, KYC trigger report, QCT review)
Perform duties & responsibilities specific to department functions & activities, and other duties & responsibilities as required or assigned by Management
Familiarize and stay updated on all policy and procedure (P&Ps) updates in the Big Green Book, internal Preferred Banking Procedures (including EaglesNet), BSA/AML KYC policies in Collaborate, and any Regulatory changes to ensure QA review is audited in line with current standards. Be proactive to escalate any questions to the QA Supervisor
Assist with research on various reports and projects as needed. Support management by proactively identifying opportunities to improve the QA Review process
Have a well-rounded understanding of the bank’s deposit products and transaction processing to have a clear grasp of BSA/AML/KYC policies and how the quality review of documentation impacts other deposit business units
The successful candidate will be someone who can demonstrate the ability to coordinate multiple priorities, successfully resolve complex matters, quickly understand processes/workflows, identify risks, and effectively tailor their communication (written/verbal) to their audience in a clear and concise manner. They must be able to identify opportunities for process enhancements while supporting existing standards with a focus towards providing excellent service to our clients. Any combination of education and experience equivalent to a bachelor’s degree, plus two years of progressively more responsible experience with audit review preferred. Complete knowledge of banking platforms used by the bank – OSI/Total Plus, Flightpath, OnBase, Ephesoft Scanning, Outlook, Adobe Acrobat, MS Office, etc

KYC Quality Assurance Associate Resume Examples & Samples

Interpretation of KYC standards, guidelines, policies and procedures
Review the quality of completed work cases to pre-defined test scripts which are based on quality assurance standards
Consider regulatory requirements and best practice to implement changes to process
Strong knowledge of KYC requirements for CIB

Quality Assurance Associate Resume Examples & Samples

Supporting, maintaining, and improving all facets of the Quality Management System for ISO 9001 & AS9100
Facilitating and leading projects and investigations across cross functional teams (e.g., technical, operations, regulatory, document control, sales, product management, etc.)
Facilitating or supporting root cause analysis and corrective action identification through the use of quality problem solving tools (i.e. 5Why, 8D, Ishikawa Diagram)
Supporting and leading the management of change process
Participating in selection, qualification, and management of suppliers and service providers
Participating in process improvement teams to provide quality input and direction
Continually evaluating systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards
Bachelor's Degree in a technical discipline with at least 5 years' experience in a Quality Assurance related role
At least 2 years of work experience with ISO 9001 or other Quality Management Standards (ISO 13485, AS9100, etc...)
Strong experience with AS9100 standards

Quality Assurance Associate Resume Examples & Samples

Job Title:* Quality Assurance Associate
Req ID:* 714516BR
Canada Walmart Division:* Distribution Centre
Province:* Ontario
Canadian Cities:* Cornwall
Store Location:* 2401 SCM Way
Employment Type:* Full Time

Quality Assurance Associate Director Resume Examples & Samples

Provide guidance to technical areas within the laboratory in order to meet all regulatory and client requirements
Direct the planning, hosting, coordinating of audits performed by sponsors and regulatory agencies
Follow-up on action items and CAPAs that arise from routine Client, Regulatory audits or other quality issues that arise to ensure appropriate and timely escalation, CAPAs and closure
Schedule, coordinate, and document in-house QA / regulatory training program for technical and non-technical areas performing FDA / EMEA regulated work and other appropriate areas as directed by QA, Compliance, or business
Perform audits of Quality System including audits of corresponding documentation to ensure compliance
Lead Quality Assurance Team Meetings
Direct the planning and execution activities of a team of direct reports as well as resourcing within the larger QA organization
Direct, lead, coordinate and participate in qualification audits of subcontractors, referral labs and or vendors as requested
Manage and perform internal Pre Study, Study and Post Study audits in relation to Bio-Analytical / Bio Equivalence
Perform raw data audits to ensure accuracy and compliance to all applicable regulations and local SOPs
Determine if and assure that study deviations are appropriately documented and communicated
Coordinate the assembly of the Bio-Analytical report and upon compliance sign off as required
Bachelor’s degree in a life sciences related discipline
10+ years Quality Assurance Laboratory Management experience in pharmaceutical, technical, or related area
California Medical Technologist License
Strong knowledge of CAP, CLIA regulatory requirements
Strong interpersonal and communication skills; must be confident interfacing and speaking with auditors, all levels of management, and senior level executives
Extensive knowledge of pharmaceutical research and development processes and regulatory environments
Senior Lab Management experience in Quality Assurance
Ability to influence and guide others at all levels of management
Working knowledge of GCP, ISO 15189, ISO 9001 requirements
Demonstrated ability to manage costs effectively through appropriate resource allocation
Demonstrated ability to articulate and define departmental needs and processes
Demonstrated ability to establish and maintain effective working relationships with coworkers, managers and clients
Demonstrated knowledge of Microsoft office suite and database applications
Risk based decision making
Excellent leadership and motivational skills

Senior Quality Assurance Associate Resume Examples & Samples

Quality representative on internal and external CMC project teams with decision making authority
In conjunction with technical representatives - review and approve manufacturing and testing Deviations/CAPAs
Review and approve cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet GMP and internal standards
Review executed batch production records to ensure compliance with approved procedures and GMP expectations. Communicate and resolve discrepancies with CMO’s
Review release test and stability data to ensure data accuracy, conformance to specifications and documentation standards
CoA approval
QA disposition of product intermediates
Conduct internal/external audits of CMO’s and other service providers, write audit reports and follow up on observations/CAPAs
Assist with the reporting and presentation of department metrics including annual product reviews
Write and review Standard Operating Procedures as needed
Bachelor’s degree in a scientific discipline or equivalent with 8+ years relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing/QC or QA
Knowledge of cGMP and applicable FDA/international regulation
Detail oriented team player with effective planning, organization, and execution skills
Innovative, proactive, and resourceful: committed to continuous improvement
Ability to make risk based decisions
Experience working with clinical and commercial products and supporting regulatory inspections desired
Experience in Small Molecule and Biologic manufacturing desired
Ability to travel domestically and internationally up to 10% of time

Quality Assurance Associate Resume Examples & Samples

Reviews, assesses and monitors records, processes, and systems at the critical control points in the manufacturing process
Monitors the implementation and effectiveness of corrective actions
Identifies manufacture, testing and/or distribution of biomedical products or services that are compromised and takes appropriate action
Participates in and/or leads internal quality reviews of critical areas, operations, and processes

Am-gwm-client Service & Fiduciary Business Control Quality Assurance Associate Resume Examples & Samples

Perform qualitative analysis of processes key to the Trusts & Estates and Client Service businesses including sworn documents and client callbacks
Develop and execute quality control/quality assurance programs of Trusts & Estates and Client Service business processes
Establish and manage the reporting and analytics of metrics for the Trusts & Estates and Client Service businesses
Develop and monitor solutions to support continual improvement of the control environment
Follow-up with Trusts & Estates and Client Service professionals to remediate any gaps identified during QC/QA
Assisting in completing requests from the Internal Audit department as well as U.S. regulators such as the OCC
Provide on-going review and assessment of Risk and Control Self Assessments (RCSAs) and existing action plans pertaining to the sworn documents process
Develop and implement improvements to various analysis, testing and verification program
Strong analytical skills, with experience in assessing the probability and impact of a control weaknesses
Excellent verbal and written communication skills, with the ability to present complex and sensitive issues to management in a concise manner
Principled, enthusiastic, self motivated, effective under pressure and willing to be accountable for work performed
Proven ability and desire to learn quickly, be flexible and think strategically
Collaborative working style, ability to manage through conflict, and ability to find creative and practical solutions to problems,
Detail oriented and proven ability to multi-task
Minimum of 3-5 years of experience
Bachelor's degree is required; advanced degree or certification a plus

Quality Assurance Associate Resume Examples & Samples

HS Diploma or higher education
Proficiency with data entry
Proficiency with MS Excel and Word
Basic ability to use MS Power Point and navigate MS Access
Familiarity with using PCs and navigating programs

Quality Assurance Associate Old Courthouse Square Resume Examples & Samples

Must have the ability to carry out detailed but uninvolved written or verbal instructions; deal with variables as they present themselves
Ability to do simple addition and subtraction; copying figures, counting and recording
Possess the ability to understand and follow verbal or demonstrated instructions; request supplies orally or in writing
Visual requirements include clarity of vision at a distance of more than 20 inches and less than 30 feet with color vision, depth perception and field of vision

Quality Assurance Associate Resume Examples & Samples

Bachelor's degree in applicable field of study or equivalent job experience
Three years experience in a GMP environment such as blood banking, pharmaceutical, medical devices or a hospital
Two years experience in QA, QC or Quality Auditing
Knowledge of federal regulatory requirements pertinent to pharmaceutical, biologic or medical device manufacturing
Demonstrated effective verbal and written skills. Strong analytical and problem solving skills. Strong skills needed to advance compliance and quality in operations; must deal effectively with management and staff in areas, at BHQ, and outside the organization. Persuasive skill to achieve compliance with relevant procedures
Must display tact, diplomacy and professionalism in difficult situations. Must protect the confidentiality of sensitive information in the department. Must operate as a team member

Quality Assurance Associate Resume Examples & Samples

Provide support for product complaint management including complaint registration, investigation, trending and follow-up with customers
Audit reports and raw data for compliance with protocols, SOPs and regulations
Communicate compliance requirements at all levels
Bachelor’s degree or equivalent in a scientific discipline with a minimum of 3 years’ experience in the pharmaceutical or medical device industry or Master’s Degree with a minimum of 2 years’ experience
Minimum 1 year of experience in regulated operations
Understanding of the FDA QSR regulations, Medical Device Directive, ICH Q7, and the ISO 13485 standard
Experience with product complaint handling, including investigation and documentation

Quality Assurance Associate Resume Examples & Samples

Perform quality/process monitoring functions allowing Biologics to maintain a proactive quality program and to exceed customer expectations, as well as industry and regulatory quality standards
Identify quality assurance opportunities by leading/participating in internal and/or external audits; including completion of all documentation requirements (audit checklists, reports and written/verbal communication)
Develop, implement and revise quality audit plans for existing and new clients according to contract requirements
Support the development and review of Standard Operating Procedures (SOP); ensure content is aligned with SOP requirements and applicable regulations
Efficiently and effectively partner cross-functionally with Pharmacy Operations, Patient Support Services, Quality Control, Program Management, and others as required to ensure compliance
Use critical thinking skills to support the development and closure of Corrective Action Preventive Action (CAPAs) and risk assessments
Analyze quality trending reports and present key observations/recommendations to stakeholders
Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements

Quality Assurance Associate Resume Examples & Samples

Assists customers by: (examples include)
Works with co-workers as a team to ensure customer satisfaction and a pleasant work environment
Adheres to company policies and individual store guidelines

Quality Assurance Associate Resume Examples & Samples

Re-creating defects within the software and determining the cause of the issue
Preparation and issuance of reports
Ability to follow a test case or test set to achieve specific results
Ability to receive a customer’s database and restore it
Understand the capabilities of the Configuration Manager, including backup, restore, etc
Familiarity with SQL Server Management Studio
Keep the QA server cleaned up by deleting old databases when detects are verified
Maintain documentation for quality assurance procedures, programs, and initiatives
Proficient in Microsoft Office programs
Maintaining a professional attitude at all times
Experience as a tester or in light accounting

Quality Assurance Associate Resume Examples & Samples

Conduct training verifications for the USCO Service department and work directly with managers and supervisors to ensure timely turnaround for sign off on the verifications
Maintain his/her own training requirements and follow overall company policies and expectations
Cross train with Manager and peer for any other assignments as applicable Conduct direct upload of training records from two repositories onto the training database on a monthly basis
Review, edit documents for punctuality and accuracy and ensure approvals are obtained accordingly
Provide training records and evidence of training during scheduled internal and external audits of USCO
2-3 years administrative experience , detailed oriented, proactive, attention to accuracy , excellent customer service both internally and externally
Preferred background: Administrative and training , working with databases and multitasking
Technical/Software tools used: Outlook, Lotus , Training database, Excel files, web-x, great working knowledge of Microsoft databases
Top 5 characteristics to be successful in this role: Organized, Detailed Oriented, accurate, focused, business professional How is performance measured: When we get no training observations during internal and external audits of the USCO organization
4 + years of experience

Quality Assurance Associate Resume Examples & Samples

High School Diploma/GED required, Bachelor Degree preferred
3+ years experience in an industrial plant environment required
Must be able to work the shift outlined in the position

Quality Assurance Associate Director Resume Examples & Samples

Manages work groups representing multiple processes and/ or regions
Bachelors or Master Degree or University Degree or equivalent plus 5+ years of relevant experience as a first level and/or second level manager
Must have 5+ years of relevant experience in commercial pharmaceutical manufacturing settings overseeing Quality Assurance
Demonstrated strong management and leadership skills in implementing program/organization strategies

Quality Assurance Associate Director Resume Examples & Samples

Provides leadership and guidance to Quality, Manufacturing, Development, Research and Sourcing departments. Establishes requirements and assures product conformance through appropriate inspection and test activities
Develops and implements quality strategy and objectives
Identifies and solves product and process problems and supports various operational groups
Prepares and monitors operating and capital budgets
Responsible for development and oversight of departmental goals and projects
Communicates and escalates issues to Sr. Management as required
Requires extensive independent decision making ability and applying regulations and standards (ISO, QSR, etc.) governing the manufacturing and distribution of medical devices
Demonstrated management ability including effective employee selection, development, motivation and performance
Understand interactions and interdependency of elements within the quality system in a manufacturing organization

Quality Assurance Associate Resume Examples & Samples

Providing hands-on coordination and support for execution of the nonconforming product (NCR) process and corrective and preventive actions (CAPA),
Working and communicating with the QA and non-QA organization across MPD to support a quick and robust decision-making process in support of quality system requirements
Supporting prioritized activities, including NCR, CAPA, FIR and operational improvements
Helping manufacturing with daily issues related to quality system requirements
Training and educating others on quality-system requirements and good documentation practices to help ensure compliance
Performing compliance audits
Advising and working with various teams (e.g. sterilization, raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, manufacturing, engineering, etc.)
Developing procedures and initiating change documentation in support of FPP for new and existing products
At least 2 years of Quality Assurance or related experience in a medical-device, pharmaceutical, biotech or other regulated industry
Demonstrated working knowledge of FDA medical device quality system regulations and ISO medical device industry standards
Bachelor’s degree in an applicable science or engineering, OR a 2-year degree plus 2-5 years medical device or pharmaceutical experience in a manufacturing or operations role
Lead Auditor Certification
Strong knowledge of E1 and PLM systems
Experience supporting various manufacturing processes

Quality Assurance Associate Resume Examples & Samples

Responsible for overseeing quality activities to ensure success against quality KPIs, including the quality associated with inbound call and email customer interactions, updates to existing customer services and set-up of new customer services
Supplement monitor allocation performed by quality vendor, focusing on individual support and coaching for low performing agents
Perform ticket audits of each operations team, ensuring the proper documentation and workflow of service request per internal procedure
Conduct audits of services to ensure SOX compliance
Produce reporting based on audits and offer suggestions, job-aids, etc. for improvement
Conduct side-by-side monitoring and coaching as requested by the supervisor/team lead or as need is recognized
Participate in monthly meetings and calibration sessions with third-party quality vendor
Complete analysis of results to identify root causes or trends that will lead to efficiency and quality gains in the contact center
Participation in new hire and skill enhancement training, helping to reinforce behaviors and processes that drive quality
Collaborate with supervisor and management to drive process improvement and technology initiatives aimed at creating efficiency and quality in operational processes
Assist in utilizing reporting tools that track performance at a department, team and individual level to measure quality rates
Assist with customer service calls, emails and spec creation as needed for business continuity purposes
Ability to work in and/or back-up all incoming call queues for the various segments within the department. Assist with dispatch when needed
Advanced typing and computer skills – MS Office (including Excel, Word, Outlook, etc.)
Identifies and resolves problems in a timely manner
Prioritizes and plans work activities
Focuses on solving conflicts and listening to others without interrupting
Balances team and individual responsibilities and helps build a positive team spirit
Adapts and able to deal with frequent changes in the work environment
Able to manage difficult or emotional customer situations and respond promptly to service requests to meet customer commitments
Demonstrate accuracy and thoroughness to meet productivity standards in a timely manner
Required to exert physical effort in handling objects less than 30 pounds rarely
Required to be exposed to physical environment which involves dirt, odors, noise, weather extremes or similar elements rarely
Normal setting for this job is: office setting

Capa Quality Assurance Associate Resume Examples & Samples

Be passionate about providing CAPA quality assurance support for a world-class manufacturer
Leading CAPA processes including
At least 2 years' experience in a Quality Assurance role in the medical-device, pharmaceutical, or biotech industry
Sound knowledge of FDA quality system regulations and ISO standards
Conflict resolution skills
Ability to
Bachelor's degree in an applicable science or engineering

Quality Assurance Associate Resume Examples & Samples

H.S. Diploma or GED is required
Excellent interpersonal skills and high professionalism
Minimum 2+ years Administrative Support or Document Control is preferred
Outstanding oral and written communication

Quality Assurance Associate Resume Examples & Samples

Support relevant stakeholders in understanding and generating appropriate systems, processes and policies, as required within defined areas of the business in compliance with QMS principles
Build strong relationships across the LOC Commercial Business functions and work with them to develop meet quality objectives
Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity
Represent GSK Australia LOC at relevant QMS forums
QMS implementation and monitoring of compliance within the Australian Rx LOC. This includes awareness and understanding of the QMS as it applies to the LOC
Ensure that local operations are in full compliance with the GSK QMS, GxP and regulatory requirements, by performing the following
Undertake assigned activities and support the development of internal procedures and systems, compliant to the GSK QMS, as well as local regulatory requirements, as assigned by the Commercial Quality Manager, including the following
Successful completion of relevant tertiary qualifications – science degree
Minimum of 3- 5 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably with Commercial exposure
Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and in the conduct of audits
Strong knowledge of regulatory requirements pertaining to GMP/GDP
Good knowledge on effective quality documentation systems
Proactive, self starter and highly motivated
Ability to work autonomously and as part of a team
Professional written and verbal communication skills
Influencing and stakeholder management skills
Analytical mind and good problem solving skills
Team work and people management skills
Good time management skills, with ability to multi-task and work under pressure
Concise and persuasive in the description of the different QA situations

Quality Assurance Associate Resume Examples & Samples

Ensures raw materials, in-process and finished products meet company and/or ISO standards
Minimize down time by reducing production rework and recalls
Perform tests and experiments for process analysts or engineers
May perform set-up of processing equipment
Monitor, audit and provide guidance to line operators
Process test runs and prepare records, charts, and graphs of results for presentation to process analyst or engineering to identify problems, inefficiencies or test new products
Provide clerical and administrative support related to documentation requirements
May audit good manufacturing practices document files relating to the maintenance, repair and calibration of manufacturing equipment in order to ensure compliance with external and internal quality assurance requirements
Resolves routine questions and problems, and refer more complex issues to higher levels
Works under direct supervision and follows standard procedures and written instructions to accomplish assigned tasks
High School Diploma/GED or equivalent combination of experience, education and/or training
Minimum of 0-2 years of related / relevant experience to position or specialization
Ability to apply basic skills and possesses the ability to develop advanced skills using tools and equipment appropriate for the position or specialization
Ability to perform standardized duties and tasks
Perform tasks to meet deadlines
Comply with Company Policies
Post-high school education

Quality Assurance, Associate Resume Examples & Samples

Review cGMP Controlled Documents such as master batch production records, test methods, and specifications. Manage implementation of required changes to meet GMP and internal standards
Review executed batch production records to ensure compliance with approved procedures and GMP expectations. Communicate and resolve discrepancies with CMOs
Review and provide input into manufacturing deviations.Track open deviations through to final closure
Review release data to ensure data accuracy, conformance to specifications and documentation standards
Participate in internal audits; write audit reports and follow up on observations/CAPAs
Participate in external audits of CMOs and other service providers; write audit reports and follow up on observations/CAPAs
Assist with the reporting and presentation of department metrics including Quarterly reports and Annual product reviews
Create and revise Standard Operating Procedures as needed
Represent QA and participate as QA Lead on CMC sub teams
Participate in regulatory inspections
Knowledge of cGMP and applicable FDA regulations
Bachelor’s degree in a scientific discipline or equivalent with 5+ years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA
Very detail oriented team player with effective planning, organization, and execution skills
Strong computer skills with Word and Excel
Ability to work effectively at a fast pace with cross functional departments
Experience supporting regulatory inspections desire

Quality Assurance Associate Resume Examples & Samples

Review transactions for accuracy and completeness and return inaccurate or incomplete transactions to the processing associates for correction
Review work items that have been completed by department Quality Assurance Associates
Monitor and provide input regarding department AWD work flow and queue management
Participate in the dispute process and provide input/resolution regarding processing procedures
Contribute to the maintenance of “library procedures”
Maintain with consistency department quality and productivity expectations
Demonstrate resourcefulness and initiate creative ideas to reduce errors and improve quality
Strong understanding of TA2000 processing procedures and computer systems
One or more years experience in the Client Service processing departments or equivalent with another Broker/Dealer
Solid verbal and written communication
Working experience with Microsoft Excel and Word
Ability to effectively adapt to change, variables, and “gray” areas
Ability to adapt to heavy work volumes
Ability to work with supervision and demonstrate good decision making skills
Demonstrate flexibility with work assignments, time, and work schedule. Overtime can be frequent and often work volumes cannot be predicted in advance. Overtime is generally worked at the end of the work shift
Demonstrated ability to work well with others
Unwavering commitment to confidentiality
Tremendous attention to detail and commitment to error-free work
Grade Level is dependent upon industry experience

Quality Assurance Associate Resume Examples & Samples

Release for products for local distribution
Complete QA tasks related to local packaging/repackaging processes
Support processing and resolution of technical product complaints
Co-ordinate the handling of rejected product and associated destruction activities
Co-ordinate the handling of product returns and associated QA assessment to determine disposition
Participate in supplier audits and self-inspections as required
Collate data for the Quality Management Review Process where required; and
Raise and investigate deviations and complete associated CAPA actions as required
Experience within a Quality Assurance role in a Pharmaceutical environment
Ability to prioritise workload in a changing environment, work efficiently and autonomously
Demonstrate a winning spirit through creating a can-do attitude and positive energy amongst others
Demonstrate high attention to detail, with excellent written and spoken communication skills
Intermediate level in MS Office Applications, Outlook, Excel and Word

Quality Assurance Associate Resume Examples & Samples

Conducting monthly internal GMP audits as directed by QA Supervisor/Manager
Conducting daily walkthroughs of assigned projects
Releasing “Quarantined” product into good upon the receipt of documentation from the client
Monitoring inventory adjustments by reviewing data gathered by operations personnel
Notifying Operations Manager and QA Supervisor/Manager of any unusual trends
Conducting random checks of inbound receipt put always for accuracy
Verifying that the system is identifying “quarantined” product accurately
Verifying that the system is identifying “released” product accurately
Work closely with Operations to identify and correct any system or human generated discrepancies inclusive of corrective and preventative action
Assist in trending data to look for ways to improve quality processes
Verify that the system is identifying “quarantined” product accurately
Guide warehouse in determining root cause of discrepancies and the development of corrective actions
Make suggestions on quality improvements and facilitate change control process when changes are made

Quality Assurance Associate Resume Examples & Samples

Maintain thorough knowledge and understanding of all Standard Operating Procedures (SOPs) pertaining to the review process
Familiarity with all laboratory techniques and equipment applicable to the tasks performed in the laboratory
Highest commitment to GMPs with regards to the recording of laboratory data for testing of pharmaceuticals and medical devices
Must have a solid grasp of the fundamentals and importance of teamwork in the contemporary business world
Must be able to think analytically
Must be capable to work at a desk and computer terminal for up to three hours at a time, and for up to eight hours on a given day

Quality Assurance Associate Resume Examples & Samples

Working knowledge of all produce items in the warehouse
Ability to properly stack pallets, preventing damage to product
Minimum 1 year produce handling experience
Must have strong speaking, reading, writing, and typing skills
Strong decision making skills
Preferred background in computer software including Microsoft Office and Microsoft Windows
Stand for extended periods of time; bend, stoop, reach, push, pull, squat, turn body, and walk
Lift and move cases (selecting product and placing on a pallet) ranging in weight up to 75 lbs continuously to and from heights ranging from floor to knee, waist, shoulder, and overhead
Use hands and fingers to peel and stick labels on cases
Must have the ability to talk and hear; must be able to hear warning horns on moving machinery and equipment
Specific vision abilities required to perform this job include close and distance vision, depth perception, color vision, peripheral vision, and the ability to adjust focus
Must be able to climb on and off the box of the truck

Software Quality Assurance Associate Resume Examples & Samples

The ability to interact with department heads regarding corporate compliance
Must be highly motivated and able influence and motivate others
Ability to make sound judgments
Ability to manage multiple tasks effectively & efficiently
Possess high-level ethics and integrity
1-3 years experience in a Validation role within the pharmaceutical industry
1-2 years experience in creating and maintaining SOPs preferred
Demonstrated above average written communication skills in the English language

ESG Quality Assurance Associate Resume Examples & Samples

Software: MS Excel, MS One Note
Sales Force (preferred, but not required)
Minimum of 2 years of experience in data operatons, quality control, support or client service
At least 2 years of working in EMEA work shift and working with colleagues abroad
Bachelor's college degree in Information Management, International Business, or similar concentration
Demonstrated analytical skills; ownership over his/her work and/or assigned subject
Strong organizational and problem-solving skills, attention to detail, background in process-oriented tasks
Excellent English comprehension (written and verbal)
Ability to work in a global team, especially in a collaborative team environment
Ability to work under tight deadlines and multiple tasks
Familiarity with data science and database management is a plus

Quality Assurance Associate Resume Examples & Samples

Establish and maintain rapport with vendors through positive and consistent communication
2-3 years minimum working in a production or QA/QC, production or Warehouse environment
Proficiency in Microsoft Word & Excel, Email
Must be proficient in English

Quality Assurance Associate Specialist Resume Examples & Samples

5+ years of relevant pharmaceutical/scientific experience
Demonstrated ability to interpret and organize scientific data
High degree of problem solving ability (e.g. performance of root cause analysis)
Experience with MS Office Suite (Excel, Word, PowerPoint)
Demonstrated ability to manage multiple priority projects/workload, ensuring timely completion
Ability to work well independently as well as part of a team
Ability to stay organized, manage time, and work on multiple documents/projects at once
Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues
Experience writing and supporting pharmaceutical manufacturing deviations and investigations
Knowledge of product complaints processing, stability protocols, manufacturing activities

Quality Assurance Associate, nd Shift Resume Examples & Samples

A minimum of a Bachelor’s degree (or equivalent) is required
A minimum of 4 years of related experience within a GMP environment is required
Strong knowledge of regulatory cGMP and CFR is required
Knowledge/understanding of drug manufacturing and packaging processes from sampling and inspection through warehouse distribution is preferred
Knowledge/understanding of Batch Record Review, Product Release, Raw material and packaging components review and approval is required
Knowledge/understanding of the product development life cycle is required
Knowledge/understanding in various computer systems: ERP, LIMS, MES and Microsoft Office (including Outlook, Word, Project, Excel, PowerPoint) is preferred
Understanding of PLC programs is preferred
Ability to work 2nd shift hours with flexibility for 1st shift when needed is required
This position will be located in Fort Washington, PA and will require up to 5% local travel as business needs require.Quality Assurance

Quality Assurance Associate Resume Examples & Samples

Perform enhanced due diligence and annual refresh for GBM high risk clients
Working under guidance of AML Advisor/Director Quality Assurance to ensure proper execution and maintenance of AML controls
Assisting in the training needs for the business lines, and the development or presentation of the training as appropriate; and
Developing and reporting metrics and preparing management reports for Business Line Compliance Op Risk and executive meetings
Minimum of 5 years in financial services and/or AML/ATF compliance
Minimum Bachelor’s degree in business, related field, finance, audit or equivalent experience
Strong communications, analytical, organizational, project management, and planning skills
Knowledge of businesses, products, operations, systems, and organization; and
Concentrated use of visual attention is required when reviewing agreements. Some eye strain is possible due to this and the use of a PC
Extreme stress is derived from pressure to meet deadlines as well as pressure from management to finalize issues
Constant interruptions create difficulties when frequent complex analysis is required. Uncertain deadlines, the lack of control over the pace of decision-making by other Bank departments and some external counterparties at times can create frustration and delays

Quality Assurance Associate Resume Examples & Samples

College degree preferred, or 3 years commensurate experience within Olympic Steel is required
Steel industry and product knowledge
Proficiency in Lotus Notes, MS Word, MS Excel applications and Olympic production control computer systems
Knowledge of customer service standard and procedures
Strong organizing, planning, prioritizing and multi-tasking skills
Strong interpersonal/communication skills with the ability to work effectively with a wide range of constituencies

Quality Assurance Associate Resume Examples & Samples

Quality Assurance testing of Company software applications and ensuring that functionality meets design specifications and business requirements
Design and execute manual tests and report findings
Provide high-level input as to the testing approach and methodology to be used in the testing of each application. Provide testing recommendations during the formulation of test plans
Participate in application development walkthrough and design sessions; provide input from a quality standpoint, and identify the specific applications and functionality that require testing
Break down business and functional requirements into use scenarios and test cases
Perform functional, integration, and regression testing for each release according to requirements documented in TeamForge
Ensure that all in-scope requirements for a given release are effectively tested
Monitor Mantis tickets assigned to QA and make appropriate recommendations for resolution
Strong observation and analytical skills; keen attention to detail and problem solving ability
Proficient in documentation of software functionality, processes and procedures using Microsoft Office
High-level understanding of web, client-server, and mainframe software development
Experience or related coursework in translating business requirements into test scenarios and test cases
Experience with data manipulation and formatting using Excel
Familiar with Quality Assurance procedures and testing approaches
Must be able to learn quickly a system with complex business processes and rules
Moderate level of technical ability to include HTML, Chrome Developer, Tools, JavaScript, and SQL
Experience with Java or similar object oriented programming languages is a a plus
Minimum of 2 years college or equivalent experience is preferred

Quality Assurance Associate Resume Examples & Samples

Assist in the management of 3rd party manufacturers
Support product artwork approval process
Support other Quality Assurance projects as required
Ideally, 1-2 years’ experience within a Quality Assurance role in a Pharmaceutical or Animal Health environment however Consideration will be given to talented individuals with significant experience in a regulated function

Lab Quality Assurance Associate Resume Examples & Samples

Work with Invitae’s QA/QC group on compliance and quality improvement projects
Serve as liaison between the wet-laboratory and the QA/QC group to ensure procedures and practices are current
Work with state and federal regulatory bodies, to maintain, document and demonstrate compliance and proficiency
Prepare for and participate in CAP, CLIA and NYS inspections, respond to recommended corrective action through process revision and preparation of response reports
Research, evaluate, validate and help to implement improvements to the current lab practices of the pre-analytical through post-analytical phases of testing
Investigate and document corrected reports, and other deviations from protocol
Write, review, and revise related policies, protocols and procedures
Plan and perform regular internal quality audits of all aspects of the laboratory as required by CAP and CLIA
Adhere to laboratory health and safety guidelines

Field Sales Quality Assurance Associate Resume Examples & Samples

1) Daily auditing of active kiosks and monthly training sessions, in the Montreal area
2) Reporting on all non-compliance immediately to Management for immediate action
3) Support and coach Sales Reps where opportunities lie
4) Reporting of all results and tracking of coaching opportunities
Assure corporate compliance is adhered to during Kiosk audits and monthly training sessions (i.e. compliance to Bell Branding, Dress code, Bell collateral, Kiosk condition, etc.)
Bilingual in English and French

Quality Assurance Associate, Hyderabad Resume Examples & Samples

Complete 100% of scheduled weekly quality reviews
Work with leadership to review program performance, consistency, and areas of concern
Provide feedback relative to compliance guidelines and highlight risk areas
Provide tracking and reporting of Quality Assurance metrics
Work with management to identify training needs
1-3 years’ experience in a Quality Assurance environment required
Proactive approach, with ability to work under remote supervision
Exposure to Information Security, and risk mitigation procedures is desirable
Previous exposure to Microsoft Outlook
Strong listening, analytical and research skills
Intermediate to advanced proficiency in Microsoft Office 365 (Word/Excel/Powerpoint)

Quality Assurance Associate Resume Examples & Samples

Sustain robust total Quality Systems for the Clinical Diagnostics Laboratory / Bioanalysis Lab and revise processes as necessary
Audit analytical batches from LC/MS runs and immunoassays for FDA submission under QSR regulation
Review and approve SOPs, forms and validation reports that are used for CLIA and FDA regulated activities
Perform internal audits and generate reports
Manage deviations, incident reports, external audits, etc
Requires a BS in a related scientific discipline with 1-3 years’ experience as a QA in a GLP regulated environment. MS degree a plus
Must demonstrate attention to detail and excellent record keeping skills
Knowledge of Microsoft Word and Excel required for review and preparation of documents and reports for inspections

Gmp, Quality Assurance Associate Resume Examples & Samples

Working knowledge of GLP, GMP, GTP
Have, organizational, and time management skills and the ability to handle a multitude of tasks
Working knowledge of electronic databases
Able to work effectively independently or in a team environment
Ability to interact well with employees at all levels
Excellent verbal, written, and interpersonal skills
Possess good problem-solving skills

Quality Assurance Associate Resume Examples & Samples

Maintain a thorough knowledge of Alorica’s programs, policies, and technology
Maintain accurate and sufficient documentation admin records including
Participate in monitoring and calibration sessions with clients
Perform other duties as assigned by the Quality Assurance Supervisor
Ability to write reports, and business correspondence

Project Manager / Quality Assurance Associate Resume Examples & Samples

Proficiency with Microsoft Word and Visio
1-3 years of experience with data driven project implementations
Strong experience in project management activities
In-depth knowledge of all phases of the Software Development Life Cycle
In-depth knowledge of relational database technology and Structured Query Language (SQL)
Understanding of financial markets and instruments
Knowledge of attribution and risk
Self-driven and well organized
Thrives in entrepreneurial environment
MBA degree
CFA or CIPM
Experience with TestComplete is preferred

Quality Assurance Associate Resume Examples & Samples

Ensure the inbound product is inspected when needed and signed off to Home Delivery Contractor to ensure 100% ownership of product and condition, accounts for all inventory in Remote Site via Tillscan. Holds Remote Site accountable to Service Level Agreement
Ensure that returning Home Delivery Trucks are checked in and product is inventoried and scanned to Till. Inspect and verify all returns with Damage Codes to ensure accountability is recorded and claims are processed when justified
Create reports to capture Shortages, Overages, Damages, Inventory discrepancies and non-conformances. Escalate concerns or issues to Regional Delivery Office
Work with contractors to ensure inventory accuracy and non-conformances are addressed
Supports Regional Delivery Office as required
Work in compliance with all laws and regulations and attend or complete all required health and safety training, report all accidents and take every precaution reasonable to ensure personal safety and the safety of others
Secondary school diploma
A minimum of 18 months of previous work experience
Demonstrated organizational/planning and analytical skills
Demonstrated oral and written communication and interpersonal skills
Demonstrated Attention to Detail
Computer skills including word-processing, spreadsheet applications, etc

100

Senior Quality Assurance Associate Resume Examples & Samples

Review and approve manufacturing, packaging and labeling and test results for API & finished drug products from contract organizations
Issues certificate of compliance and performs product disposition according to established procedures
Write, review and approve SOPs, test methods, specifications, protocols, and reports, and other documentation related to product disposition
Participate in change controls, product complaints, deviations and CAPA’s associated with manufacturing, packaging and labeling, and shipping activities, and OOS, annual product reviews and review of pertinent CMC sections of regulatory filings
Participate in mock product recall
Review vendor audit reports
Participate in vendor management program in activities such as providing feedback on (i) planning of vendor audits, (ii) any quality or compliance concerns from interactions with CMOs, (iii) review of vendor audit agenda, (iv) review of vendor audit reports and (v) any post-audit tasks assigned, such as review/follow-up on vendor’s CAPA’s
Compile quality metrics data related to QA CMC
Any other tasks assigned by Head of Quality or designee
Minimum B.Sc/M. Sc. degree in chemistry, biochemistry, or microbiology with 2 -7 years’ experience in the Pharmaceutical or biotechnology industry
Demonstrated knowledge of GXPs, ICH, and other regulatory guidelines for manufacturing, testing, and release of pharmaceutical products
Experience in handling commercial and clinical release, manufacturing deviations, OOS investigations, and product complaints with close attention to detail and adherence to cGMPs
Experience in working with contract facilities is preferred
Experience in sterile injectables, lyophilized products and biologics is desirable
Ability to manage priorities
Solution –oriented approach to QA CMC work
Strong working knowledge of Word, Excel, and PowerPoint
A certification in quality is highly desirable
Must be available to work in the evenings and weekends, as required

101

Quality Assurance Associate Resume Examples & Samples

Performing quality audits, inspections and unit testing for equipment
Performing troubleshooting of issues with equipment
Documentation and reporting of all test results
Perform incoming inspections on components
Work with vendors for processing rejected parts
Qualified candidate must have three plus years of previous industrial experience
Must have a great attention to detail
Minimum education of a high school diploma or GED required
Previous quality testing background preferred
Basic computer skills to include MS Office and email
Previous electrical and hydraulic knowledge a plus
Ability to read and follow blueprints

102

Quality Assurance Associate Resume Examples & Samples

Perform Deviation, Out of Specification (OOS), Method Validation Failure (MVF), and/or microbiology investigations following staff performance of customer test requests in a timely and effective manner
Ensure that all testing submitted by customers is completed within established parameters governing Company quality and regulatory compliance specifications
Ensure that all reasonable requests from Department Management pertaining to review of laboratory data supporting a given test or group of tests are met in a timely and effective manner
May act as a liason to customer auditors and regulatory inspectors and coordinate inspections involving the company as necessary with regulatory agents on-site
Perform internal audits of departments, data, systems and facilities. Report findings to management. Organize and plan follow-up inspections as part of corrective action processes
May conduct phase audits of GLP studies per 21 CFR Part 58
Perform audits of vendors and subcontractors as mandated by executive management. Approve qualified vendors and review vendor surveys as needed

103

Gmp, Quality Assurance Associate Resume Examples & Samples

Collaborate with Regulatory Staff in ORAQ and serve as key quality resource for projects as needed
Review quality agreements and quality documentation associated with manufacturing at Duke or in support of a Duke clinical trial if CMO is used
Write, revise, and review SOPs
Assist in managing quality-related matters during internal/external inspections
Prepare QSU Quality reports
Lead continuous improvement projects and initiatives
Attend meetings with Quality personnel
Assist with Deviation/Event management including corrective action and preventative action (CAPA) management and root cause analysis
Develop, compose, and review analytical, equipment and process validations
Assist with material/component inspection and control
Support vendor qualification processes, including performing audits to assess suitability of vendors/contract laboratories
Assist with batch review/release
Track and trend metrics and identify areas of concern

104

E-commerce Quality Assurance Associate Resume Examples & Samples

Ability to prepare and present recommendations for QA improvements that address short and long-term objectives of the business
Strong planning and time-management skills, with demonstrated ability to handle multiple tasks simultaneously, prioritize projects, and meet deadlines
Strong and palpable “sense of urgency”
Genuine enthusiasm and excitement for Lilly Pulitzer merchandise and brand positioning
A Bachelor's degree in Computer Science, Information Systems, Business Administration or equivalent practical experience
Working knowledge of HTML, XML, CSS, and JavaScript

105

Quality Assurance Associate Resume Examples & Samples

Adhere to food safety and HACCP Principles
Monitoring and maintenance of all products
Perform all line checks to ensure compliance with product specifications
Record keeping, including but not limited to, lot verification, weight verification, temperature verification, etc
Uphold the safety and quality standards of the company

106

Training Quality Assurance Associate Resume Examples & Samples

Perform copyediting on materials including instructor slides, instructor guides and student workbooks. Ensure compliance with technical documentation standards, and improve clarity and flow of information
Perform user test on training lab exercises. Report issues and comments back to the author via our JIRA process
Work with the Training Quality Assurance Specialist to define our processes and develop templates, in line with industry standards and best practices. Balance the need for fast Time to Market with requirement for high quality customer facing materials
Assist the Training Quality Assurance Specialist to educate the ADLS staff on our process and template requirements, as well as enforce these on a day to day basis
Consistently improve and innovate our process, templates and tools
Document guidelines and standards for course developers to ensure consistency across globally distributed team. Provide knowledge transfer and mentoring to drive adoption of standards and improved quality
Provide final approval of customer-ready quality levels for all course material developed by Curriculum Development team
Maintain strong stakeholder relationships, and partner with ADLS teams to ensure high quality and accurate materials
Adobe InDesign
JIRA
Basic web application QA testing
Internal content repository systems (i.e. Scene7 and Drobo)
Basic SnagIt and/or image editing tools for screenshots

107

Quality Assurance Associate Resume Examples & Samples

50% Product safety and quality systems implementation, maintain ingredient approval, training, assessment, and compliance
20% Proactively manage and resolve product safety and regulatory issues in collaboration with head office quality team, regulatory affairs insuring root cause identification and preventative actions. Provide targeted follow-up on claims and complaints
20% Develop a working knowledge of pre-mix Quality Control, systems, processes, and procedures as related to plant manufacturing. Act as the champion for product safety/quality; monitor and repost on trends alerting the Director and/or Sr. Quality Mgr
5% Lead assigned projects in critical process monitoring and capability; working with operations, QA/QC, and plants to establish new product/process measurements and preventative control at the source
5% Able to back up divisional formulator and create formulations in Brill software as needed

108

Senior Quality Assurance Associate CZ / SK Resume Examples & Samples

Responsible for the execution of Quality Management System and Compliance elements such as documentation, record, metrics and KPIs, dashboard, training documents, document review, standard gap assessment, Consolidated supplier overview, audit schedule and audit follow-up within SEE of the Transport & Temperature Control activities (e.g. during IBF, OBF, LTL, Parcel shipment)
Responsible for overseeing the development / remediation controls and quality standards for all distribution and inventory management activities (e.g. receiving, pick, pack, lot reconciliation), and managing communication on progress within J&J
Responsible for the quality oversight of all product quality holds and field actions impacting the Distribution Center
Accountable for ensuring requirements for physical product testing (e.g. functional testing, visual inspection & verification) occurring in the DCs
Responsible for ensuring implementation of the requirements for repackaging and relabeling operations to be conducted within the Distribution Center
Accountable for ensuring appropriate Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC
Accountable for ensuring adherence to temperature control and monitoring requirements within the facilities
Responsible for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of Quality related issues
Responsible for overseeing the controls and quality standards for Quality systems validation, including WMS, CAPA, NC, Internal Audits, Doc management software systems
Responsible for ensuring management of Management Reviews of the DCs
Accountable for the successful management of all Health Authority inspections conducted
Responsible for the proactive identification and mitigation of compliance risk at the DCs through internal audits
Complete University Level Education Pharmacy to be able execute as deputy QP for Good Distribution Practice and Narcotics Handling according to relevant local legislation
Change management and project management experience
Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority
Compliance experience, QMS experience
Issue remediation experience
Collaborative approach
Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc
Fluent in Czech/Slovak & English
Organized, must have excellent communication and presentation skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations

109

Quality Assurance Associate Resume Examples & Samples

Across multiple projects (typically > 3 concurrent projects) provide satisfactory QA support such as review and approve master and executed batch records, deviations, OOS/OOT investigations, test method qualifications and validations, stability and Quality Control data and reports compliance to internal and GMP standards
Identify issues that may impact products or failures to comply with local or regulatory procedures/guidance and propose appropriate solutions to resolve issues
Represent the department during project meetings, client audits and FDA inspections, if needed
Provides guidance to Quality Assurance staff in the accomplishment of Quality Assurance operation activities
Recommend and provide supporting evidence for the cessation of manufacture activities and/or distribution of product, if necessary, to QA management
Review master documents such as In-process forms and Batch Records
Approve stability study protocols, reports, and test methods
Is knowledgeable in the understanding of all EH&S policies and procedures
Ensures that all job activities comply with any EH&S related rules and regulations that pertain to the department
Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2025 principals into daily activities

110

Quality Assurance Associate Resume Examples & Samples

2-3 years of operational experience in a Product Quality or certified (e.g. ISO) manufacturing environment and HS Diploma
Exceptional analytical, problem-solving, and root-cause analysis skills
General familiarity with spreadsheet, word processing, and email software
Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820

111

Quality Assurance Associate Resume Examples & Samples

Analyzes/audits live and recorded calls, emails, and customer surveys to identify areas of service delivery that did not meet pre-established performance standards within the Contact Center
Provides structured and timely recommendations; verbal and/or written feedback to Contact Center leadership, Contact Center operations, and the Training teams
Develops and conducts targeted group coaching sessions for analysts that address Service Quality deficiencies and/or improvement opportunities
Uses customer service expertise to assess existing practices and procedures for process improvement opportunities with all Contact Center teams and sites
Bachelor’s degree or equivalent business experience preferred
Quality Assurance related work experience demonstrating excellent analytical and reporting skills as well as contact center customer service & telephone phone skills required
1 to 3 years experience in customer service and/or business process/technology support required
Ability to negotiate change across organizational/firm boundaries. Adept at networking and building relationships with all levels of management and staff
Ability to work in virtual team environment
Experience with Avaya / Verint WFO a plus
BI-lingual ability preferred

112

Quality Assurance Associate Resume Examples & Samples

Become familiar with operations for cell-based therapy at SCCA
Learn regulations and standards specific to cellular therapy
Perform audits of Apheresis and CTL
Review processing documentation and release products for infusion
Review controlled documents for compliance issues
Provide regulatory guidance on collection and processing issues
Write investigation reports regarding significant deviations/variances
Qualify suppliers of critical materials
Perform metrics and analytics
Participate in hosting inspections
Develop and maintain effective working relationships with a variety of colleagues and stakeholders, including cross-functionally
Identify process improvements, facilitate development and documentation
Write, revise, review and implement controlled documents. Assist in document control activities
Maintain understanding of applicable regulations, standards, scientific theory, terminology and practice at a level to be able to work effectively with CTP colleagues. This includes learning about new cell-based therapeutics entering clinical trials in which CTP participates
Baccalaureate degree (BA or BS)
Outstanding organizational skills
Collaborative
Experience preparing and reviewing regulated documents
Strong skills with Microsoft Excel and Word
Experience interacting effectively with vendors
Experience related to laboratory information management systems beneficial
Knowledge of regulatory requirements and standards for cell-based therapy preferred
Previous GXP QA experience required

113

Technical Quality Assurance, Associate Resume Examples & Samples

BS in Computer Science or related disciplines preferred
0 to 2 years' experience in software industry with an in-depth understanding of QA methodologies associated with Agile/Scrum
Experience on Agile/SCRUM, and TFS
Experience working with .NET Web based applications
Experience with Microsoft Test Manager, ISTQB

114

Quality Assurance Associate Resume Examples & Samples

Assist in the review and processing of quality documents associated with clinical, manufacturing and technical support documentation. Author and/or review SOPs as needed
Provide hands-on QA support in the MBR and EBR review including batch release as needed. Assist in the QC of genealogy reports received from CMOs
Assist in the management of Lexicon’s employee training program and serve as MasterControl administrator and as backup across all functional areas
Support CAPA program, deviation management, internal/external audit program, assignment tracking numbers, and in label and packaging control and specifications associated with components, drug substance and drug product
Generate and create quarterly quality metrics/indicators associated with quality systems
Support all quality systems associated with GxP operations in collaboration with GMP and GCP directors to ensure compliance at all times
Bachelor’s Degree required in biological/life sciences or chemistry
A minimum of 2-4 plus years of GxP experience in the pharmaceutical industry with a minimum of two years in pharmaceutical quality assurance functions
Experience working in solid dosage forms is required
Training in the use of MasterControl is a Plus
Ability to communicate effectively between departments/disciplines in a matrix environment
Outstanding ability to produce technical documents for all levels of corporate structure and regulatory authorities
Must be exceptionally attentive to detail and organization

115

Senior Quality Assurance Associate Resume Examples & Samples

The routine analysis of production samples and raw material samples by various wet, classical and instrumental methods
The operation of instrumentation such as densitometer, PSA, pH meter, Karl Fischer, and FTIR
The standardization of various instruments and titrants in addition to the maintenance of SPC control charts and routine maintenance of laboratory equipment is included in the job duties
Preparation of monthly reports, project summaries and equipment justification are also functions of the position
8 – 10 hour work day, depending on business needs
Assist with ISO/RC and any other relevant audits required for certification
Immigration sponsorship not offered for this role

116

Senior Quality Assurance Associate Resume Examples & Samples

High pharmaceutical education
2 years+ experience in the pharmacy warehouse by an authorized person as a must
Experience in Quality Assurance within Pharmaceutical business preferred
Business travel (25-30% of working time)00001A77

117

Quality Assurance Associate Resume Examples & Samples

Conducts batch record review and approves batches for release
Assist with the Material Supplier Evaluation Program
Assist in scheduling and compliance of Environmental Monitoring, Equipment Calibration, and Equipment Maintenance Program
Issues Deviation, CAPA, and OOS investigations. Tracks investigations and outcome. Reviews and recommends approval of indicated actions to senior Auditors
Assist Document Control in review, filing, and issuance of AMRI documents
In conjunction with senior Auditors, conducts Self Audits of all areas of AMRI and assists with writing audit reports
In conjunction with senior auditors, acts as QA liaison to assigned project teams
Assists with customer/regulatory agency audits when necessary
Writes and reviews Annual Product Review reports
Writes protocols for Process Validation Protocols and assists with writing of Process Validation Reports
Assists with customer inquiries and investigations of customer complaints
Understanding of Good Manufacturing and Laboratory Practices, FDA regulations, SOPs, and current compliance standards
Ability to audit documents, procedures, and records for accuracy and continuity
This position requires a B.S. degree and 0- 3 years’ experience in pharmaceutical manufacturing or 4-8 years of equivalent experience

118

Senior Quality Assurance Associate Resume Examples & Samples

Undergraduate degree in engineering, scientific, business or QRC disciplines. Will accept the equivalent of 10 years relevant industry experience if no degree
5 years+ experience in Quality Assurance within Pharmaceutical, Medical Devices or FMCG business
DC Q&C management
Managing complexity
Previous experience interfacing with regulatory agencies, and a history of success and credibility resolving complex regulatory compliance issues
Fluent in German & English
Organized, Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations
Must have strong collaboration skills “hands-on” operational orientation

119

Clinical Quality Assurance Associate Resume Examples & Samples

Moderate to expert skill-level in Microsoft Excel and other Microsoft office programs is required
The role may also be responsible for authoring or assisting with procedure writing and/or training development or any other project related items for Inventory Management
This person will be trained and mentored by a Clinical Supply Logistics colleague, before working on the project
They will be responsible for regular interactions with MedSci partner lines, external vendors and quality assurance when clarity may be needed whilst reviewing/managing and transcribing data
B.S. degree in related field, required

120

Senior Quality Assurance Associate Resume Examples & Samples

Assists in providing disposition to bulk, intermediate, finished product and components based on batch record review for compliance to the current Good Manufacturing Practices, compendia standards and specifications. Inspects materials, reviews batch records for completeness and accuracy of entries, assesses the adequacy of investigations of deviations and verifies the conformance of test results with the established standards
Assists with the review and approval of all quality documentation e.g. SOPs
Assists in the evaluation of failure through notice-of-event (deviation) reports; assigns and communicates corrective and preventive actions (CAPA), both written and verbal to responsible departments; provides follow-up on corrective and preventive actions and assesses the effectiveness of corrective and preventive actions. Performs trend analysis for periodic review
Assists with review, approval and release of all non-conformances
Assists in the evaluation of change (change control) to validated processes, equipment, procedures and manages processes as needed
Authoring and revising SOPs and forms
Coordinates and performs, as required, internal and external audits of contract manufacturers and vendors. Writes audit reports and tracks and trends completion of corrective and preventive actions
“Person in plant” activities – monitoring of manufacturing activities
Review of product labeling
Coordination with distribution (product returns, managed quarantines, communicated product releases, etc
Recommends and conducts projects to improve the efficiency and effectiveness of the quality system. Develops and maintains databases and spreadsheets to support Quality Assurance systems as needed
Assists in the preparation and review of quality agreements
Manages compendia changes. Reviews applicable compendia and works with contract manufacturers to ensure continued compliance of products to compendia standards
Assists in the review of validation protocols and reports for processes, equipment and computerized systems
Establishes and maintains databases for tracking deviations, corrective and preventive actions, (CAPA) and change controls
Participates in Cross Functional Investigations
Participates in and provides leadership for projects as designated by upper management
Ensures that cGMP requirements and industry Quality standards are adhered to
Establishes and maintains effective work relationships within the department, the Company and the community; and maintains the professional competence, knowledge and skill necessary for the satisfactory performance of all assigned responsibilities
Bachelor’s degree (minimum) in a technical field or relevant scientific discipline i.e., Biology, Chemistry or Engineering
10 - 15 years’ experience with increasing responsibility in a quality assurance (QA) function
Significant hands on experience in a pharmaceutical company, including clinical and commercial products
Hands on experience participating in the implementation of quality systems in a GXP environment and experience with FDA and other health authority inspections
Knowledge of US GXP compliance regulations (21 CFR 210 and 211 cGMPs and Part 11) and industry practices
Computer knowledge to include databases, spreadsheets, etc
To perform this job successfully, an individual should have general computer knowledge as well as the following: Word, Excel, PowerPoint, Access, Outlook, etc
Analytical – Collects and researches data; analyzes information skillfully
Technical Skills – Excellent knowledge of manufacturing/packaging operations for evaluation of batch status; demonstrated knowledge of laboratory testing and data collection for raw materials and products for evaluation of batch status; knowledge of Microsoft Office and Access software
Communication – Listens carefully and gets clarification. Able to express complex ideas in a clear, concise manner. Capable of explaining technical issues to non-technical personnel
Team Work – Contributes to building a positive team spirit
Written Communication – Writes clear, accurate and concise technical and non-technical documents

121

Curriculum Quality Assurance Associate Resume Examples & Samples

Works closely with the Editorial and Quality Assurance team to ensure that curriculum in both online and offline (print and web-based) formats adheres to predetermined criteria
Assists the Manager of Quality Assurance regarding issues regarding the academic integrity of existing curriculum using database tools and documents these issues in order to capture and report this data to internal/external users
Becomes familiar with Connections Education’s general editorial style guide to perform editorial functions as necessary such as proofreading text for accuracy, consistency, etc
Works with the other functioning groups within the Curriculum department as needed
Provides regular status reports for all activities related to the project
Identifies new processes to meet the curricular demands of the program
Develops self to improve performance in current role and to prepare for future roles, and seeks and provides feedback and coaching to enhance performance; and

122

Quality Assurance Associate Resume Examples & Samples

Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP)
Reviews and compiles master production batch and control batch records
QA project lead for manufacturing campaigns
Provide validation/preventative maintenance support for critical equipment and write associated protocols
No supervisory responsibilities, but may provide training to new staff. Will be the QS lead on manufacturing projects as assigned. Coordinate activities of lab aide/assistant staff as directed
Wear pager, or other communication devices, and respond to emergency calls
Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP). Assist QS in establishing and maintaining Quality Systems as they pertain to facility operation
Writes, reviews and processes the approval of Standard Operating Procedures
Assists in internal inspections and audits (manufacturing, QC, safety) to ensure compliance with Federal Drug Administration (FDA) regulations and City of Hope and QS policy requirements
When necessary, assist with receiving, acceptance, handling, and storing of raw materials
Responsible for the continuous operation of the facility’s mechanical systems, monitoring systems and equipment. Responsible for co-coordinating preventative maintenance and maintaining cGMP compliance of all building systems and major process equipment (e.g. autoclaves, dishwashers, depyrogenation oven), as directed by QA Manager
Assist in the preparation of cGMP training program and conducts staff cGMP-training as necessary and maintains documentation
Cooperates with other performance improvement and compliance activities in the institution
Maintains and creates databases to track and trend monitoring data including environmental monitoring, equipment maintenance, excursions in facility operations. Analyze trends and generate reports/updates from these databases
May be required to conduct external vendor audits
May be required to attend off-campus training or COH training seminars
Masters of Science with 0 – 4 years of experience, preferred

123

Quality Assurance Associate Resume Examples & Samples

Manage Vendor Qualification System Audit vendors: coordinate travel, audit, and provide audit reports to the vendor
Manage controlled substance activities: ordering and completing DEA 222 forms; receive, log, issue controlled substances for laboratory testing, and maintain logbooks
Manage the Product Complaint process: intake, process, investigate, and trend complaints
Speak with patients and follow-up with vendors, physicians, pharmacists, etc
Route manufacturing and quality documentation to vendors and management
Initiate, review and route deviations and non-conformance documents
Issue, review, and approval Change Controls CCs related to all controlled documents
Perform QA document review on manufacturing and quality documents
Establish training for other departments and directly train employees in other departments
Write, review, and revise SOPs, protocols, etc

124

Senior Clinical Quality Assurance Associate Resume Examples & Samples

Responsible for the QA/QC content review of clinical trial-associated documents for new and ongoing programs
Bachelor’s Degree in Science or related field (preferred)
5+ years’ experience within Clinical Quality Assurance. Regulatory Affairs experience is helpful
Experience with clinical trial protocols, CSR’s (Tables and Listings, Source document verification) IND, NDA, BLA review
Familiarity with eCTD (Electronic Common Technical Document) format
Demonstrated advanced writing, reviewing skills, with strong command of the English language and grammar, strong organization skills and attention to detail. Working knowledge of ICH, FDA GCP requirements

125

Quality Assurance Associate Resume Examples & Samples

A Bachelor’s degree in life sciences and 5-7 years of experience in a quality assurance role or an equivalent combination of education and experience is required
Experience working in GLP/GMP environment and strong knowledge of GLP/GMP’s required
Experience in cell and gene therapy is strongly preferred
Demonstrated ability to work collaboratively, multi-task, and prioritize in a fast-paced environment a must
Strong analytical skills and attention to details required
Must have demonstrated experience meeting critical deadlines
Experience with Microsoft word, excel and access required. Proficiency with access databases preferred

126

Quality Assurance Associate Resume Examples & Samples

6+ months with LendingClub operations
Self-motivated, driven, and works well with others
Desire to pursue a career in Contact Center Quality Assurance field
Profient in Excel and PowerPoint

127

Quality Assurance Associate Resume Examples & Samples

Performs quality inspection and documentation for incoming biopsies
Reviews and approves records and associated data in support of cGMP operation activities
Creates batch records, product labels and performs label verification processes
Performs quality reviews and approvals of batch records. Responsible for dispositioning batches
Participates in company projects as a quality representative
Participates in risk assessment activities
Performs investigation report writing, reviewing and closing investigation reports
Conducts and documents training events
Management of customer complaints
Authoring quality system documents
Performs various office-related duties; filing, scanning, and data entry
Promotes GLP/cGMP environment and follows procedural guidelines
Bachelor’s degree in any Life Sciences or equivalent and/or at least 5 years of relevant experience in QA or equivalent experience
Knowledge of cGMP regulations and good documentation practices preferred
Demonstrates excellent problem solving and critical thinking skills
Detailed oriented and good written and oral communication skills
Experience in risk assessment preferred
Must be familiar with Microsoft Office applications

128

Quality Assurance Associate Resume Examples & Samples

Knowledge of phases of the Software Development/Testing Life Cycle
Knowledge of relational database technology and Structured Query Language (SQL)
Experience in JAVA, .Net, Ant, Java script, PowerShell, and MSSQL
Understanding of performance measurement and GIPS

129

Quality Assurance Associate Resume Examples & Samples

Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years’) or equivalent combination of education, training, & experience. Successful completion of PPD Foundation Training
Meets competencies for Associate QA plus
Basic computer skills and ability to learn and become proficient with appropriate software

130

Quality Assurance Associate Resume Examples & Samples

Live Our Values: People, Service, Quality and Innovation
Rework product that requires improved packaging or labeling
Inspect the quality, durability, and consistency of product
Ensure product stored/putaway/picked/shipped accurately and in a manner that will not damage the items
Comply with individual, team and departmental productivity and performance goals
Conduct operations in a manner which promotes safety and in accordance with federal, state, and local laws
Perform or assist in building, grounds, and housekeeping as required
Abide by all security policies and procedures
Ensure that the warehouse is consistently clean and free of debris

131

Quality Assurance Associate Resume Examples & Samples

1 – 3 years of related work experience in Auditing
Detail oriented and good organization skill
Self-starter and good problem solving skills
Ability to work in a multi-task environment
Strong mathematical and computer skills
Associates degree from an accredited college
Fluent in Spanish – not required, but would be a plus

132

GSS Third Party Oversight Quality Assurance Associate Resume Examples & Samples

Conduct quality assurance testing of line of business execution against firm-wide Third Party Oversight standards
Evaluate line of business control processes to determine their effectiveness and compliance with firm-wide standards
Conduct root cause analysis to determine source of business execution issues or ineffective controls
Partner with lines of business to determine appropriate remediation for identified issues
Validate effectiveness of remediation actions via discretionary quality assurance testing
Manage the efficient, timely entry and maintenance of documentation
Open to work in Night Shift - Important

133

Quality Assurance Associate Resume Examples & Samples

Design and execute test plans on web applications
Work very close with the rest of the development team to ensure the feature satisfies stakeholder expectations
Contribute to our automated tests library
Experience driving best practices in adoption and use of the advanced quality assurance techniques, including test automation, white and black box testing, predictive models, risk analysis, requirements engineering, test driven development,security testing, and continuous integration, build and release management
Hands on experience developing and implementing test strategies

134

Quality Assurance Associate Resume Examples & Samples

Maintaining and advancing the portfolio of projects
Providing technology planning/IT roadmapping, information security advisory services, and cyber resilience planning across the WPO
Collaborate with Service Delivery Organizations to provide technology excellence in support of the Fedwire Services
Develop and execute comprehensive test plans, test cases and execution scripts for highly complex Fedwire® business lines (over 40 applications)
Review test output and document results including logging and following up on identified problems
Utilize an end to end test management toolset (Silk Central), covering test validation linkage to its requirement
Develop a thorough understanding of all Fedwire® applications, interfacing applications, statements and reports
Key contributor to the development of business and user requirements for existing and/or new Fedwire® applications
Key contributor in recommending best solutions in achieving the business objective
May assist in the development of user training material; train various users (Wholesale Operating Sites, Wholesale Testing Unit users, and Backup Production Operations support team
Provide Fedwire® business operations and production support (including off hours and weekend support)
Work closely and collaborate with various project and operations stakeholders across Federal Reserve System
Support multiple concurrent initiatives occurring in numerous environments across all Fedwire® Business lines
Develop strong relationships across all QA Testing Teams and negotiate QA environment schedules for competing time critical projects and ongoing maintenance activities
Coordinate and support production implementation of all environmental and application changes to the Fedwire® applications to meet business production high availability requirement. Requires on-site weekend coverage to support this activity
Analyze and report production problems and operational issues to senior management and stakeholders. Work closely with technology groups in identifying the root cause and resolving the production problems
Stay abreast of the Quality Assurance techniques by self-training and on/off site courses
Bachelor’s degree preferably in Computer Science or Management Information Systems or equivalent work experience
Three to Five years of Quality Assurance testing experience in distributed applications, including web-based applications
Strong hands-on experience with multi-tier distributed technologies
Experience with Silk Central; Test Lifecycle management tool
Ability to create and troubleshoot SQL queries
In-depth knowledge and understanding of testing methodologies to define end to end test scenarios encompassing business process validation
Experience with non-functional testing and tools: Jmeter, SilkPerfomer
Knowledge of test automation tools such as the Silk suite of tools; Selenium
Knowledge of and experience with Fedwire® business, Payment Systems and/or Central Securities Depository systems is extremely desirable
Strong organizational and project planning skills, including the ability to participate in multiple projects with tight deadlines
Strong written and verbal communication skills. Must be able to communicate and share testing status with Function management and appropriate stake holders
Demonstrated ability to work effectively both independently and as part of a team
Ability to interact with various levels of staff and management
Certification in Quality Assurance (process/tools) or ability to obtain certification highly desirable

135

Senior Product Quality & Assurance Associate Resume Examples & Samples

Manage the end to end functional, business case and system integration testing of DHL Portal
Prepare the test cases/ documents on the basis of business requirement
Perform API testing and promote best practices
Prepare API user guides for customer implementation and considering legal and compliance implications
Bring best practices on BAT testing
Review test documentation and ensure it’s of a high quality
Ensure BAT environment is up and running prior to BAT commencing
Prepare API user guides for customer implementation
Work closely with business & technology teams, including offshore
Oversee Country BAT to ensure a sufficient level of quality is reached prior to live implementation
Collate daily BAT Reports and submit to the Manager
Ensure adherence to the internal processes including the defect management process
Identify issues and recommend solutions based on test result analysis
Escalate issues as required to ensure testing is carried out in an efficient manner
Generate the necessary test data for different stages of testing
Provide pre-Implementation as well as post-Implementation support
Deployment of change request and patch for the application
Incident support, performing root cause analysis, resolution execution and escalation of unresolved incidents

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