QA Associate Resume Samples

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G Beier

Giovanni

Beier

55227 Carroll Valley

Chicago

+1 (555) 434 8117

55227 Carroll Valley

Chicago

Phone

p +1 (555) 434 8117

Experience Experience

New York, NY

QA Associate

New York, NY

Metz Inc

New York, NY

QA Associate

Provide management with recommendations for staffing and process improvements
Perform real time review of executed Batch Documentation and prepare for eventual disposition by QA management
Assists in performing final approval and release of product for shipment to customers
Perform initiating/updating of Standard Operating Procedures within MasterControl with management oversight
Work closely with Learning and Development team in grading new hires/new lending authority training for Credit agents
Perform ticket audits of each operations team, ensuring the proper documentation and workflow of service request per internal procedure
Collect and analyze process, sanitation, and quality data, and make recommendations to operations and quality management based on analysis

Houston, TX

QA Associate Compliance

Houston, TX

Yost, Schamberger and Mante

Houston, TX

QA Associate Compliance

Develops recommendations for internal audit corrective actions/improvements and establishing timelines
Assists with management of electronic quality management system processes
Facilitates and manages the internal audit program
Develops detailed internal audit plans and prepares detailed audit reports
Creates, revises, and reviews SOPs
Performs regular walk-through audits of GMP areas
Develops detailed audit plans and conducts comprehensive audits

present

Philadelphia, PA

Senior QA Associate

Philadelphia, PA

Predovic-Ferry

present

Philadelphia, PA

Senior QA Associate

present

Working directly with the Manager, eClinical Quality Assurance in hosting/facilitating Customer audits
Work with Quality improvement and other quality challenges in close collaboration with mainly internal customers
Provide Quality support to risk management activities
Working directly with the Manager, eClinical Quality Assurance in responding to client audit observations
Provide QA support to initiate, participate and contribute to PQS process improvements initiatives and projects
Execute Supplier Management Program activities such as non-conformances, Quality Agreements, change notifications, audits and corresponding reports
Work with peers on all Alkermes sites and relevant steering committees on streamlining & harmonising common work practices and procedures

Education Education

Bachelor’s Degree in Industrial Pharmacy

Ashford University

Bachelor’s Degree in Industrial Pharmacy

Skills Skills

Excellent ability to work with the development team throughout the QA cycle to deliver a high quality product
Demonstrated basic computer skills and a working knowledge of basic computer software to include Microsoft Office and Microsoft Excel
Ability to maintain professional and positive attitude
French or German mother tongue (with good knowledge of the other language), fluent English
Strong attention to detail and some experience in Verification
Basic Scientific Knowledge
Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients
Good communication skills with ability to communicate effectively across all organization levels
Strong attention to detail
Good organizational skills and attention to detail

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Cib-QA-associate Resume Examples & Samples

Application Development - Preferred; Not Required
Mainframe testing experience - Desired
QTP Automation Script Creation - Advanced
Education and Experience-
Bachelor's degree in Computer Science, or Information Technology or related experience
3 years in software quality assurance with significant testing and automation experience
2 years experience with test automation tools QTP and HP Quality Center is a MUST - This includes scripting, programming and maintenance (not just record-and-play)
Experience with design, creation, execution, and reporting of both manual and automated test cases
Proficient with Functional testing, System Integration testing, Security testing, Negative testing, User Acceptance Testing and Performance/Load testing
Desired experience using various database query tools -
Proficiency in SQL is desirable
Strong time management and interpersonal skills

Cib-QA-associate Resume Examples & Samples

Good Unix skills
Data analysis skills (including SQL, spreadsheet analysis)
Has written regression test packs for batch processes / deployments
Core Java, Fitnesse

QA Associate Resume Examples & Samples

5+ years progressively responsible related QA and production experience in a medical device or FDA regulated industry
Bachelors of Science Degree in quality or science (chemistry, biology, engineering or medical technology) or related field
Must be knowledgeable of cGMP and OSHA regulations in a regulated medical device or distribution (medical devices) environment
Demonstrated experience in cGMPs, FDA regulations, and SOP development and technical writing
Experience in a manufacturing/operations or distribution environment
Demonstrated basic computer skills and a working knowledge of basic computer software to include Microsoft Office and Microsoft Excel
Customer service focus (internal and external)
Experience and knowledge of ISO13485 or ISO9001 standards

QA Associate Resume Examples & Samples

6+ years of experience in writing test plan, strategy and test cases from business/IT requirements. Highly skilled testing in UNIX/Linux, & Windows application
3+ years of database testing experience in SQL, Sybase/Oracle, DB2
3+ years of experience in leading geographically diversified team with onsite and offsite resources. Strong presentation skills and capability of maintain transparency is requied

QA Associate Resume Examples & Samples

Ability to discuss and understand business requirements with the business teams
Excellent ability to work with the development team throughout the QA cycle to deliver a high quality product
Excellent verbal and written skills are necessary especially with remote global teams
Experience building GUI test plans and test cases
Experience using UNIX shell scripting or Perl programming
Knowledge of MQ Series, SQL and XML
Experience using HP ALM/Quality Center, JIRA
Knowledge of the financial services/brokerage industry
Experience of TestComplete, Perforce, GIT

Senior QA Associate Gmp Resume Examples & Samples

Proven experience in a QA/compliance related position within the pharmaceutical or life-sciences industry
Profound knowledge and understanding of EU and US cGMP regulations with respect to the production and testing of pharmaceutical and/or biological products
Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements. Sound decision making
Experience independently performing internal and external Quality Systems Audits
Trained green belt. Certification is considered a plus
Clear experience working with/improving pharmaceutical Quality Management Systems
Minimum requirement of a bachelor degree in Sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc.). Degree in pharmacy and QP eligibility is a plus
Must be fluent in English; French and Dutch would also be beneficial

WLO CB / KYC / Qc-QA / Associate Resume Examples & Samples

People and resource management (e.g. people development, attrition, pipeline/skills monitoring, training programs) for the team
Maintain effective and standard operational processes
Improving and maintaining a controlled environment (e.g. necessary control activities along with process flow implemented, appropriate control tools in place, team members fully understand risks and related controls)
Manage relationship with internal clients, anticipate needs, take feedback, run conference calls
Act as a point of contact for escalations and high priority requests from internal clients
Monitor and actively prioritize workloads. Send early warning reports if workloads impact turnaround time or quality parameters
Take responsibility for the quality of work submitted and ensure that the highest standards are maintained
Identify/ manage risk and control breakdowns
Manage the performance management cycle- Objective setting, development and career planning, performance appraisal and reward & recognition
Conduct regular team meetings (onshore and offshore staff), 1:1s, and coaching sessions
Improve the departmental competency rating via use of staff training and the skills matrix
Develop and maintain written procedures and training materials as necessary
Manage projects and conduct User Acceptance Testing for enhancements to current systems or migration to new system
Excellent people and resource management skills (e.g. people development, pipeline/skills monitoring, training programs)
Ability to develop, implement and maintain effective and standard operational processes
Ability to maintain and improve a strong controlled environment (e.g. necessary controls activities along process flow implemented, appropriate control tools in place, team members fully understand risks and related controls)
Ability to manage relationship with internal clients. Past experience in this area with emphasis on service level deliveries, expectations setting, new products etc. is a must
Act as a point of reference for team members and internal clients
Ability to monitor and actively prioritise workloads
Ability to interpret and analyze system generated reports and other data, co-relate and analyze impact to overall processes and process deliveries and feed results into the decision making process
Graduates with a minimum of 7 years experience in a bank, financial services, compliance, risk management or other service sector environment OR Qualified professionals (e.g. CA, ICWA, and MBA) with 5 yrs relevant experience
Strong Interpersonal skills. Should be able to communicate at all levels
Sound understanding of AML and BSA regulatory requirements and knowledge of wholesale banking products preferred
Behavioral skills, Leadership, Problem solving and time management
Strong planning, negotiation and analytical skills
Excellent business writing and verbal English communication skills
Proficient use of PC software for document and worksheet preparation/presentation
Strong control and quality management skills; accuracy and attention to detail is vital
Assertive and self-confident
Previous experience of change management (e.g. new system implementation , business restructuring) within the organization
Excellent coaching skills
Good delegation skills
Well developed negotiation, persuasion and influencing skills

Cib QA Associate Resume Examples & Samples

Inspect schema and compare to data in the table to insure that the correct datatype was used to load the data
Identify and develop SQL and VBA code to perform QA testing based on Field Type (different QA is required for date, time, character, numeric and float data)
Identify and develop SQL code to perform QA testing based on business criteria (work with business area to identify calculations, verify that these calculations can be performed based on the datatypes, data content and selection criteria. Refine calculations and produce result sets showing problematic results)
Work with the group doing database loads and the groups providing source data to help root out the cause of issues (e.g. some errors are introduced due to Excel precision and parsing). Extract and provide the data the groups need to use to trace the source of the problem
Generate SQL code in an automated way so that queries can be developed quickly and accurately. Use of Excel functions and macros to produce this code is encouraged since data schema are being delivered that way
Stack queries so they can be run overnight; save both the query and result sets in the same file so queries can be run on large datasets continually and it is clear which result set came from which query
Analyze and summarize all result sets and be able to clearly communicate the issues
Efficiently store queries so that once issues are corrected, data can be re-checked and confirmed to be corrected
Estimate completion dates based on the size of the file (number of records, number and type of data fields)
Depending on the dataset, additional queries will need to be developed
Hours are regular London hours
Experience with data in financial markets
SQL for Oracle, with ability to run in TOAD and/or SQL+. Expert knowledge of data types
Excel including VBA and Macro development
Data analysis and problem solving skills

Senior QA Associate Resume Examples & Samples

Plan and perform routine analyses with efficiency and accuracy
Plan and perform multiple, complex routine/non-routine methods and procedures
Report, evaluate, back-up/archive, trend and approve analytical data
Troubleshoot, solve problems and communicate with stakeholders
Initiate and/or implement changes in controlled documents

Cib QA Associate Resume Examples & Samples

1) Strong QTP VB/VBA Scripting Skills
2) Strong QA/Testing/Automation Concepts
3) Strong Communication Skills
4) Eager to learn and work on new QA Scripting Technologies like Shell ,Perl, Python

QA Associate Resume Examples & Samples

Bachelor’s degree in computer science or related field required
1+ years of experience in QA, specifically in financial industry required
Comprehensive understanding of SQL necessary
Previous experience with a defect management system preferred
Familiarity with Scrum testing environment preferred

QA Associate CMO Management Resume Examples & Samples

Coordinates with CMO’s to obtain data required to generate the APQR’s. Reviews the data received and generates the final APQR for review and approval by QA management and Qualified person
Initiation of deviation records in Shire’s Trackwise for major and critical deviations occurring at CMO’s or manufacturing plants for chosen product
Reviews and provides status reports of compliance related records such as Deviations, CAPAs, Change requests, Technical Quality Agreements, Complaints and training records
Supporting business review meetings with CMO/external parties and representing Shire in a professional manner
Maintains active working relationships and has regular review meetings with the record owners to ensure timely closure of the associated records
Perform audits as assigned per the ongoing external audit schedule
Escalates issues proactively to management in case of compliance gaps
Prepares reports, maintains quality metrics and makes recommendations to management
Implements adequate communication processes and maintains CMO partnership
Authors, revises and/or reviews Standard Operating Procedures, Guidance Documents, Technical/Quality Agreements, and other documents as assigned
Maintain required QMS databases
Practical knowledge of working with QMS databases such as Trackwise
Knowledge of/experience with aseptic processing and biologicals is a plus

Hardware QA Associate Resume Examples & Samples

Participate in the product development process, testing prototypes for failures and performance measurement
Develop and prototype test jigs, test tools, including their design, fabrication, assembly, and testing
Use proprietary testing tools to test large numbers of pre-production and production samples for functionality and product quality
Collect, organize and analyze data related to RF, IR, electrical component and full product performance
In collaboration with electrical engineering, product and software teams, develop new product specifications meeting all product requirements
Manage and author documentation, data and product requirements
Diagnose basic electronic issues through physical testing and general tools (like multimeters)
Communicate effectively with creative, software, and product development teams
Bachelor degree, preferrably in mechanical engineering, electrical engineering, industrial engineering or equivalent experience
Ability to assimilate and prioritize conflicting demands and requirements, and find novel solutions to complex problems
High degree of comfort with ambiguity in early-phase investigative projects
Familiarity with soldering and other basic electronic workshop tools
Extremely organized with attention to detail
Background in QA engineering, especially around consumer products and consumer electronics
Experience with Python and/or C++

QA Associate Resume Examples & Samples

Monitor calls and provide representatives feedback and coaching
Review mail processing work, emails and customer service for quality and accuracy
Serve as resource for Customer Service Representatives (CSRs) by providing information and guidance
Alert management of potential issues
Update and maintain report and tracking tools
Assist in facilitating training
Provide management with recommendations for staffing and process improvements
Maintain up to date knowledge of services and procedures
Assist in the development of training materials

QA Associate Resume Examples & Samples

Bachelor’s degree in related field, or equivalent work experience
Minimum of 3 years of experience in health insurance/claims processing organization
Detail orientation and strong organizational skills
Maturity of judgment under pressure/ability to resolve problems in a timely, effective manner
Personal integrity and demonstrated commitment to sound, ethical, moral and legal business standards and practices
Flexibility and ability to handle varied functions/conflicting demands
Good written/report writing and verbal communications skills demonstrating clarity
Proficiency with Microsoft Office 2007 Suite, including Word, Excel, and PowerPoint

QA Associate Resume Examples & Samples

Master degree in Chemical/Pharmaceutical sciences or equivalent by experience; Degree in Industrial Pharmacy is an asset
1-7 years of experience in a strongly regulated or GMP environment
Extensive knowledge of Quality Assurance and Compliance
Experience with the release process of Clinical Trial Materials is an asset
Experience with the Good Clinical Practices and Good Distribution Practices is an asset
Ability to provide cGMP compliance support by investigating and resolving quality issues is required
Strong collaboration skills, able to influence without authority, good communication skills towards both the shop floor and senior management, able to lead in a diplomatic way
Leadership Skills are required, team lead experience is an asset
Proficiency in computer applications such as MS office is preferred; Experience with SAP is an asset
Excellent verbal & written communication skills.Quality Assurance

QA Associate Resume Examples & Samples

You are responsible for the handling of events with regard to the manufacturing unit. You assess the impact of critical and non-critical events and you reach out to other groups if needed (production, QC lab, environmental monitoring group, GTS, engineering, stability,…) for support during the investigation
You perform internal audits and check rounds as per schedule
You review and approve validation documents such as protocols, reports, master documents, rationales, statement, cleaning recipes,... in order to maintain compliance to regulations, guidelines, J&J policies and standards
Experience in the pharmaceutical industry and in depth knowledge and expertise in cGMP standards
You are fluent in Dutch & English (written and spoken)
You have strong influencing, collaboration and negotiation skills
You are able to correctly estimate the urgency, criticality and impact of decisions related to the function

QA Associate Externe Producten / EU Release Resume Examples & Samples

You are responsible for batch release of the products. You track regulatory approval and compliance with GMPs and manufacturing authorization before releasing product. You are in close contact with the QP with regard to any issues that would arise during the release process
You are the single point for release activities for the products
In consultation with the relevant departments you define corrective and preventive actions after which you follow up on implementation and you monitor effectiveness of the actions
You maintain a current knowledge of international regulations, guidelines and new evolutions related to the different quality processes through self-learning, literature studies, internal and external benchmarking and courses/conferences. You implement this knowledge to maintain and improve the quality processes at Janssen
You review and approve quality documents such as changes, procedures, annual product reviews,…
You prepare for regulatory and customer audits and inspections and you are the spokesperson for the related products during audits and inspections
You have a degree of Industrial Pharmacy, Bio-Engineering, or equivalent degree/by experience
You are capable of working in cross-functional teams and motivating people
You have good communication, organization and planning skills
You have demonstrated experience in writing and managing compliance documentation
You possess the credibility and experience to act as subject matter expert during internal audits and external regulatory inspections
You are capable of demonstrating the ability to manage QA aspects within complex projects, priorities and multiple tasks and are able to correctly estimate the urgency, criticality and impact of decisions related to the function

Senior QA Associate, QA Document Control Resume Examples & Samples

Pre approval of production orders for clinical studies, label artwork and other ancillary documents
Performs Post review and approval of batch records generated during the production process
Performs the review and approval of material specifications specific to packaging
Performs the review and approval process for Distribution Study Set Up & Distribution Study Amendment processes
Prepares new and reviews existing Standard Operating Procedures related to the processes for Document Review
Investigation and review of any complaints or unplanned deviation reports in association with Packaging/Distribution ensuring documents are completed within the agreed timelines. To ensure any discrepancies are identified and that timely action is taken to remedy the situation referring any issues to Senior Management
Acts as initial point of contact for client comments and queries in relation to Batch Record Observations
Audits – assists with client audits as Subject Matter Expert in the QA Document Control processes
To assist the QA Document Control Manager in the training of all QA Associates to ensure adequate training to perform required tasks
Provide an input into the recruitment process for the QA Document Control Team
To assist the QA Document Control Manager in the management of workloads and priorities on a daily basis
Responsible for the team in the absence of the QA Document Control Manager
Performs Adhoc duties as requested by the QA Document Control Manager
Must be educated to at least degree level or equivalent in relevant subjects
Related experience/knowledge of IMPs and Clinical Trials/Protocols
Previous working experience in clinical trials Packaging and or Distribution
Ability to work with a team providing support to other team members
Ability to work without direct supervision/own initiative within the remit of the role
Significant discretion and initiative
Responsible for own work
Teamwork/Cooperation
Problem Solving and decision making

Senior QA Associate Resume Examples & Samples

Function as QA representative on project teams primarily relating to facility, utility equipment and computerized system changes/upgrades to support site projects and the introduction of ALKS products
Participate as QA representative in qualification/validation based activities relating to facility, utility, equipment and computerized system changes/upgrades to support the above
Review and approve validation and project documentation relating to facility, utility, equipment and computerized system changes/upgrades in line with site/global procedures
Review and approve deviations and change requests generated during these projects
Initiate and/or review Change Control updates as they pertain to the project activities
Work proactively as part of a team and provide constructive input into resolution of problems impacting on Quality and the project
Provide Quality support to risk management activities
Provide support to QP certification for ALKS clinical supplies as required
Competency in the use of computerised systems
Maintain a high standard of documentation as required in a GMP facility
Participate in compiling and maintaining departmental KPIs

Senior QA Associate Resume Examples & Samples

Authority to approve written procedures and other documents
Perform Annual Product Reviews
Execute Supplier Management Program activities such as non-conformances, Quality Agreements, change notifications, audits and corresponding reports
Evaluation of change control records
Support regulatory and 3rd party inspections
Follow-up on actions related to audits’ observations
Interact with plant personnel to insure CGMP compliance
Evaluation and approval of complaints
Provide support to projects, metrics and other quality systems, when needed
8-10 years’ experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms
Working knowledge of US and European Drug Product GMP requirements and associated guidelines with ability to increase others knowledge
Experience in administration of quality systems for drug product development, manufacturing and quality assurance operations

Senior QA Associate, Quality Systems Resume Examples & Samples

Executes tasks associated with Quality Systems and applicable databases as an individual contributor which includes collecting and classifying information appropriately. Updates related databases in a timely manner. Generates status reports as required and maintains the database
Subject Matter Expert (SME) in one or more of the Quality Systems: Training, Documentation, Change Control, Product Complaints, Annual Product Reviews and Management Review
Utilizes technical skills and tools effectively to identify issues, evaluate risk and facilitate appropriate solutions to management
Coordinates the collection and tabulation of metrics related to the Quality Systems as directed by supervisor
Assures AUST/QAA and vendor compliance with corporate policies, SOPs and regulatory agency standards. Identifies issues and initiates corrective action as required
Assists in the coordination of recalls and regulatory agency inspections as necessary
Collaborates with departmental and cross-functional teams to address cGMP compliance issues and complete projects as assigned
Responsible for the storage and maintenance of departmental forms (hard copy and electronic.)
Authors, revises and performs maintenance and administration of departmental control documents (i.e., SOPS, WPDs, STLs, etc.) as necessary
Project management of assigned projects
Minimum BA/BS with 3 of industry experience with a minimum of one year of QA experience
Knowledge of cGMPs and other industry regulations
Effective communication and interpersonal skills, ability to ensure team success as an individual contributor, attention to detail and understanding current trends of industry standards relating to Quality Systems (Training, Documentation, Change Control, Product Complaints, Annual Product Reviews and Management Review)
Must be able to represent the company to external stakeholders including health care professionals
Requires experience with information management systems to log, track and trend applicable Quality Systems
Demonstrated experience in two or more of the Quality Systems highly desired
Executes assigned tasks following sufficient management oversight/guidance

Senior QA Associate Resume Examples & Samples

QA support in analytical method transfer. Approval of analytical method transfer plan, protocols and reports
QA support in Drug Substance technology transfer
Approval of process validation master plan, protocols and reports
Creation of Drug Substance Release Testing Specification
QA Approval of sample plans,
QA Approval of deviations and CAPAs
PQM assessor in change control requests
Hosting weekly Quality forums with partner
Participate in partner Quarterly Review Meetings
QA support in Annual Product Review
Responsible for maintenance of the Quality Agreement
To assess drug substance quality through review batch production records for intermediate products and drug substance (Upstream)
Be part of the disposition process of Drug Substance batches
Work with Quality improvement and other quality challenges in close collaboration with internal and external customers
Minimum 10 years’ experience from biotech or pharmaceutical industry
Knowledge of Good Manufacturing Practice (GMP)
Strong English communication and writing skills

Senior QA Associate Resume Examples & Samples

To assess drug substance quality through review batch production records for intermediate products and drug substance (downstream), and through being on the floor during manufacturing as applicable
Perform QA review and approval of Deviations and CAPAS
Assess and approve for execution change control requests
QA representative in Drug Substance Technology Transfer
Act as primary QA Downstream contact for the manufacturing team as needed
Be part of the disposition process of Drug Substance batches. Opportunity to become a delegated Qualified Person
Perform review and approval of documentation, including master records, work instructions and standard operation procedures (SOP´s)
Act as subject matter expert in audits and inspections from competent authorities and external parties
Work with Quality improvement and other quality challenges in close collaboration with mainly internal customers

QA Associate Resume Examples & Samples

Issues manufacturing batch records and labels
Reviews all ancillary facility and equipment records in support of GMP operations
Reviews Assay Qualification, Equipment, and Stability Protocols
Assures the Cell Bank and Bulk Drug Substance are manufactured and tested in a manner consistent with the applicable regulatory or client requirements
Identifies and drives resolution of all documentation and batch record issues to allow for timely release
Prior pharmaceutical Quality experience
Prior cGMP documentation practices
Direct Reports: N/A
Total Site Staff (includes directs): N/A

QA Associate Resume Examples & Samples

Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients
Documents all incoming complaints in to complaint management system timely and notifies other QA specialists for start of investigations
Provides acknowledgement letters to the complainant upon receipt of complaint
Notifies appropriate organizations for any product replacement requests from the complainants
Conducts follow up calls to the reporters as required
Communicates any Safety events to Drug safety
Provides general support to the quality systems group including but not limited to database maintenance and report outputs
Shipment of prepaid Fedex labels to the complainant for sample return
Performs returned sample receipt, storage and assessment
May participate in cross functional complaint related teams
May perform investigation of minor complaints
May perform basic data analysis in support of complaint investigations, trend reports and APQRs
Perform reconciliation of Drug Safety events
Ensure compliance with applicable regulatory requirements with current Good Manufacturing Practices (cGMPs)
Normally receives general instruction on routine work, detailed instructions on new assignments
0+ years of relevant experience in a GMP environment related field and an AA degree

QA Associate Resume Examples & Samples

Review documentation SOPs, validation documents, specific quality assurance reports, executed MBRs/PBRs, and executed MPSP
Responsible for QA inspection reports
Manage warehouse environment monitoring program
Monitor and manage stability samples and chambers
Handle and issue OOSN and NCR
Responsible for sampling duties such as, raw materials, contact plates, blend uniformity, and cleaning validation swab tests
Responsible for release and rejection of materials
Other tasks as assigned by the company
S. or higher degree is required
2-3 years working in biotechnology or GMP pharmaceuticals environment; laboratory experience is a plus
Excellent communication and interpersonal skills to work with cross functional teams
Great organizational and time management skills
Requires strong computer skills in Microsoft Office (Excel, Power Point and Word)
Fluent speaking and good writing skills in both English and Mandarin

QA Associate Resume Examples & Samples

Receipt, quarantine and release of incoming raw materials
Initiates documentation per SOP for receipt of cGMP materials and performs receiving inspection for some components and moves materials to quarantine status
Coordinates material movement, sampling and labeling of raw materials and components with Supply Operations
Interacts with Supply Operations personnel to resolve receipt and/or invoice discrepancies
Initiates and performs investigation in Quality Events in Quality System when appropriate
To perform the physical tasks involved in receiving, shipping and storing of raw materials, finished products, in process used materials and other supplies
Coordinates material and product transfer requirements directly with Manufacturing personnel
Performs various inventory transactions on the ERP system. Responsible for supporting complete and accurate inventory transaction documentation and files
Maintains required segregation, security, labeling and storage conditions for all inventory materials
Performs routine cycle counts, evaluates variance reports, investigates discrepancies and recommends corrective actions
Approves materials for release to supply operations by reviewing appropriate documentation
Maintains clean, organized and safe warehouse
Disposes of expired and nonconforming material to EHS
Prepares temperature sensitive filled product for shipment to commercial partners as well as contract manufacturers per SOP’s
Minimum 1 year of relevant Pharmaceutical Industry Quality Assurance experience preferred
BS/BA degree in scientific discipline from an accredited college or university or equivalent preferred or equivalent work experience
Strong knowledge of GMP’s and their application
Good written, oral, and interpersonal English communication skills
Must be competent literate and proficient with ERP inventory transactions
Ability to handle multiple responsibilities- self motivated
Ability to provide clear information effectively to peers in day to day work relationships
Willing to work with chemicals and hazardous goods
Knowledge of handling temperature sensitive products including exposure to environment in cold storage areas
Familiar with clean room gowning requirements and will work in a classified environment
Ability to lift 60 lbs. and ability to manage multiple responsibilities- self motivated
Ability to operate material handling equipment

QA Associate, CMO Resume Examples & Samples

Coordinates QTA & Audit programs
Drives QTAs towards completion; manages QTA renewal schedule
Manages Audit schedule and finalization of Audit reports in the Global system
Assists Associate Director, QA, CMO with routine quality assurance functions
Document management and cGMP document archiving and organization for easy retrieval
Assist with review and approval of batch records, change controls (TrackWise), deviations, Corrective/ preventative action records, and standard operating procedures
Assist with review and approval of validation protocols, master plans, and reports for CMO manufactured products

Senior QA Associate Resume Examples & Samples

5+ years current experience in a Regulatory or Quality Assurance role within the pharmaceutical industry
5+ years experience in conducting and facilitating customer/vendor audits
5+ years experience in creating and maintaining SOPs preferred
CAPA, GCP, process development and improvement experience strongly desired
Ability to maintain professional and positive attitude
Must be highly motivated and able to influence and motivate others
Proficient at problem-solving
Possess high-level of ethics and integrity

QA Associate Resume Examples & Samples

Phones experience (Loan Sales, Member Support, or Payment Processing/Solutions)
Ability to interact with individuals at all organizational levels
Desire to pursue career in Quality Assurance field

QA Associate Resume Examples & Samples

Conduct regular evaluations of Credit loan and documents review (e.g. loan conditions, income documents, tax returns, banks statements, credit reports, etc.)
Conduct regular evaluations of Credit phone calls
Partnering with central training team in grading new hires/new lending authority training for Credit agents
Support monthly business review meetings by gathering evaluation results and feedback for operations leadership
6+ months Lending Club Credit experience or similar
Ability to review, analyze, and verify income documents such as personal tax returns, bank statements, credit reports, etc
Fluent in general lending guidelines and loan terminology
Strong analytical, critical thinking, and problem solving skills
Superior written and verbal communication
Self-motivated, driven, and plays well with others—high energy and positivity is a must

QA Associate Resume Examples & Samples

Previous work experience at junior reviewer or inspection role in pharmaceutical manufacturing, GXP, QA, QC, environments
Previous work experience as junior documentation researcher, reviewer author or administrator
IT literate - MS Office – Word, Explorer, Excel, Access, Outlook
Previous GXP experience
Previous QMS utilisation experience

Marketing Optimization Control / QA Associate Resume Examples & Samples

Expert-level SAS programming with 3+ years of recent experience in data management (extraction, transformation, and manipulation)
Working technical experience with relational database servers with advanced SQL. (2+ years of recent, intensive SQL experience.)
Comfort and experience working in a Unix environment as well as Windows
Strong technical documentation skills
Good interpersonal skills coupled with proven experience communicating to business and technology stakeholders
College diploma or university degree in the fields of computer science, statistics, operations research, another technical discipline, or 5+ years equivalent work experience
SFTP client/command line experience
Unix KSH script experience
Experience using software version control tools preferred (Crucible, Tortoise/SVN)
Knowledge of applicable data privacy practices, laws, and regulations
Experience in campaign marketing area
Knowledge of targeted marketing campaigns

Senior GMP QA Associate Resume Examples & Samples

Release all finished drug products to the market in accordance with the registered specifications and with local/international regulations following batch release Key Quality Indicators (KQIs)
Manage and ensure effectiveness of Change Control system; responsible to assess, evaluate and execute QA related implementation plan as part of local Change Control process is in place
Act as QA responsible to provide oversight to all the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance. Coordinate all required activities to guarantee that third party manufacture, (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards
Support in CPO readiness for all GMP/GDP regulatory inspections and internal global audits
Maintain AQWA Trackwise system for complaints, deviations, quality events, CAPAs and artwork; act as QA responsible to perform evaluation on deviation, technical complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures

QA Associate Resume Examples & Samples

Post Compounding check and Release
2 years experience of working in a aseptic compounding operation
12 months experience of quality system implementation

QA Associate Resume Examples & Samples

Ability to remain objective when evaluating agent calls
Must be proficient with using computerized systems
Previous quality experience is preferred, but not required
No active written corrective actions
Must have a minimum of 6 months frontline experience at Xerox, to apply
Must average 91 or higher in quality, over a 90 day period, to be considered
Proficient with basic task assigned using Microsoft Word, Excel, and Outlook
Proficient with Sam’s Club systems, policies, and procedures that are related to servicing members

Senior QA Associate Resume Examples & Samples

QA support for assembly batches for devices and commercial finished products manufactured at our site in Hillerød
Support commercial projects related to product launches, product life cycle development etc
Close collaboration and daily contact with the Assembly, Label & Pack and support functions both in Hillerød as well as globally in Biogen in Switzerland and in US
Review of documentation, deviations, CAPA, Quality Agreements etc. related to batch disposition
Participate in compliance audits
You thrive in an international, multi-cultural environment where things are constantly changing
You are self-driven, positive and proactive and you take responsibility for your assignments
You are a strong team player, but also capable of working independently
Profound knowledge of Good Manufacturing Practice (GMP) is a requirement and knowledge within ISO 13485 is an advantage
2-3 years of experience from biotech or pharmaceutical industry is preferred and especially experience within assembly processes and devices are an advantage

Senior Research QA Associate Resume Examples & Samples

Ensure Research studies are conducted and data collected in compliance with approved protocols, appropriate corporate guidelines, internal work procedures, domestic and Japanese (i.e., JRS) regulatory guidelines and standards
Assign protocol numbers for new Research studies and maintain document control of protocols and study reports
Maintain the change control database for Research computerized systems (including equipment and validated computer systems)
Ensure new Research systems are properly evaluated for software validation needs in accordance with internal Work Procedures and Corporate policy
Monitor and facilitate Research staff training on SOPs/WPIs with emphasis on functions generating Research output intended for regulatory filings
Assist with the monitoring and training of Research staff on SOPs/WPIs
Publish the monthly status reports of Research QA activity
Provide Quality guidance to Research personnel as required
Perform data integrity reviews of Research, Process Sciences, Analytical and Formulation Development and Quality Control reports and data intended for regulatory filings
Training of existing and new Research personnel who are involved in writing and executing Research protocols and study reports subject to the internal Research Quality system
BA/BS or equivalent with typically 7+ years relevant experience or typically 5+ years with Master's degree in a biotechnological and/or pharmaceutical development Quality Assurance setting
In lieu of a Life Sciences degree, consideration will be given to candidate with minimum of typically 11+ years of relevant industry experience in a biotechnological and/or pharmaceutical development Quality Assurance setting
Experience in a pharmaceutical development environment with knowledge and review experience of in-vivo and in-vitro Research study protocols and reports for investigational stage products
Familiar with FDA regulations including Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations, FDA Guidance, and ICH Guidance
Able to multitask, handle multiple projects at one time, and change priorities based on business needs
LI-EP

Senior QA Associate Resume Examples & Samples

Review, approve and reject raw materials, packaging components and critical consumables for use
Review and approve Laboratory deviations and CAPAs generated during analytical testing and method development and validation
Review and approve any laboratory generated reports related to deviation trends, Analytical development laboratory protocols and reports, product related issues or impact assessments
Work proactively as part of a team and provide constructive input into resolution of problems impacting on Quality and the project or material impacted
Review, approve and provide quality oversight of vendor issues on incoming materials
Work with other QA departments to ensure quality systems are maintained
Participate or lead self inspections
Prepare Vendor sections for APRs
Preparation and tracking of site internal audit schedule
Participate in regulatory and customer audits as required e.g. audit preparation room, retrieving and returning site documents
Attend meetings related to key responsibilities

Senior QA Associate Resume Examples & Samples

To manage the workload and priorities on a daily basis for EPO and Post approval stages (and associated tasks) are reviewed to meet Operations timelines
Ensure all GPMS issues affecting the approval of batch records are completed with the required timescales
Prepares new and reviews existing Standard Operating Procedures (and associated documents) relating to the processes for batch record review to ensure standard working practices
Investigation and review of any complaints or unplanned deviation reports in association with batch record review ensuring documents are completed within the agreed timelines. To ensure any discrepancies are identified and that timely action is taken to remedy the situation referring any issues to the QA Document Control Manager
Acts as initial point of contact for client comments and queries in relation to batch record observations
To assist the QA Document Control Manager in the training of QA Associates (packaging) to ensure adequate training to perform required tasks
Provide input into the recruitment process for QA Document Control team
Provides a point of contact for the team in the absence of the QA Document Control Manager
Must be educated to degree level or extensive experience of pharmaceutical GPM
Previous working experience in clinical trails Packaging / Distribution
Previous experience in a supervisory role is advantageous
Team work and co-operation within team and different shifts
Problem solving and decision making

Senior QA Associate Resume Examples & Samples

5+ years in Quality Assurance within Pharmaceutical, Medical Devices or FMCG business
Experience as an internal auditor / lead auditor is an asset
Change management and project management experience is an advantage
Knowledge of quality and regulatory compliance in delivery to customer and health authority
Compliance experience, QMS, DC Q&C management experience
Strong presentation skills, collaborative approach, analytical skills, attention to detail
Fluent in Slovenian & English

CPO Development QA Associate Director Resume Examples & Samples

Minimum of 10 years of clinical research experience in the pharmaceutical industry. Experience in quality assurance, clinical development, field monitoring or auditing is a plus
Must be proficient of GCP, ICH and FDA regulatory requirements
Familiar with CAPA and Root Cause Analysis process
Effective oral and written communication skills are a must
Ability to lead project workstreams, work both independently and collaboratively on project teams
Must be flexible, dynamic and willing to adapt in a fast-paced environment
The ability to travel up to 10% is required
English fluent in speaking and writing

Contract QA Associate Resume Examples & Samples

Data Integrity review of regulatory documentation and submissions
Ensure all data are verified against identified and approved data source documents
Identify and communicate data discrepancies observed in data integrity review to supervisor
Quality Assurance operational support
Apply job related skills and understanding of policies and standards in completing tasks
Four or more years of experience in the quality function
Working knowledge of FDA cGMP requirements and guidance documents
Broad quality experience, preferably including manufacturing operations, API and drug product release
Familiarity with regulatory Submission process
Experience using Document Management Systems
Proficient with MS Word, Outlook and Sharepoint

Tax Conversion QA Associate Resume Examples & Samples

Develop test cases sufficient to test all facets of tax return conversion specifications developed by analysts
Identify program deficiencies and communicate them to product development and test corrected code
Review detailed tax return input and output to assure alignment with program behavior
Research and resolve related customer inquiries and production issues
Bachelor Degree in Accounting, Finance or Business Administration preferred. Relevant experience will be considered in lieu of a degree
Minimum 2 years’ experience in Tax Accounting or Tax Preparation preferably with complex individual, partnership and corporate returns
Ability to review complex tax returns line by line to determine appropriate tax outcomes, and identify problems, issues or inconsistencies between source and output
Ability to proof-read customer facing documentation and report inconsistencies
Ability to work both independently and in a team environment
Ability to work an extended and flexible schedule as required to meet objectives
Strong written and communications skills are essential

QA Associate Resume Examples & Samples

Assist with the oversight of the supply chain, manufacture and packaging of BioMarin products in various Contact Manufacturing Organizations
Review of Manufacturing/Packaging batch records and Quality Control records prior to recommending release of batch
Review and approve standard operating procedures (SOPs) and master batch records
Review deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented
Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements
Assist with regulatory inspections
Artwork Approval
Support the following activities, as appropriate
6+ years experience in a cGMP regulated manufacturing and packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance

QA Associate Resume Examples & Samples

Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives
Support the Technology Transfer of a new product into the site including raw material and supplier qualification
Support quality systems on site
Review and approve deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented
Assist with internal audits to ensure compliance with cGMPs and other regulatory requirements
Minimum 5 years’ relevant experience in a cGMP regulated manufacturing and packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance
Strong ability to communicate, present data, and defend approaches in front of audiences and inspectors

QA Associate Resume Examples & Samples

French or German mother tongue (with good knowledge of the other language), fluent English
Master in a scientific discipline. Master in Pharmaceutical Sciences or PharmD preferred
Previous QA experience in a pharmaceutical/biotechnological environment is a strong advantage
Must be a self-starter, able to work under own initiative and meet deadlines under pressure
Ability to independently analyse data and information to draw conclusions and make effective decisions
Ability to effectively interact with (verbally and written) and influence internal and external personnel on many aspects of project and product and quality related matters
Solid knowledge or willingness and aptitude to acquire knowledge of relevant legal requirements of the glocal pharmaceutical industry, including the interpretation and practical application of applicable regulations

QA Associate Resume Examples & Samples

Monitor and audit sanitation processes
Inspect process control points, Critical Control Points, and Essential Quality Attributes
Perform sensory evaluations of ingredients and product
Provide technical support; provide training and skill development to production personnel on various quality and food safety techniques
Technician will be expected to be knowledgeable on quality systems and regulatory requirements
Collect and analyze process, sanitation, and quality data, and make recommendations to operations and quality management based on analysis
Maintain and update controlled documents including quality, operational and sanitation policies, procedures and forms
Communicate summaries of quality data to customers and plant management
Collect and ship samples to testing laboratories in a timely manner
Responsible for ensuring work area is clean and organized
Ability to work independently with little or no supervision and as a member of a team
Responsible for Food Safety and Quality of food
Experience and Education: High School Diploma or equivalent and two years related experience
Skills: Must be proficient in MS Word and MS Excel software. Basic math skills
Pre-Employment Tests:The candidate will be subjected to pre-employment criminal background and drug screening tests. Any job offer will be subject to satisfactory completion of these tests. Other skill-related tests may be required
Experience and Education: Bachelor’s Degree in Biology, Chemistry, Food Science or related science field or equivalent
Systems: LEAN Manufacturing
Language: Bi-lingual Spanish

QA Associate Resume Examples & Samples

Performs routine Environmental Monitoring sampling
Reviews and updates Standard Operating Procedures (SOP's)
Participates in execution of validation protocols
Reviews laboratory investigation reports (inclusive if provided by third party purveyor)
Participates in training of other employees
Helps with receipt / sampling / testing / release of raw materials and products. Monitors, performs and documents sampling / testing and inspection of raw materials / components / in-process samples and documents the results in compliance with cGMP and company procedures
Updates corporate microbiological environmental monitoring results database
Accurately performs in-process inspections. Documents all activities on appropriate forms or in the batch record. Reviews completed batch records and issues batch records and associate forms to production
Maintains quarantine / release / reject system dispositions for raw materials, labeling materials and finished drug products
Notifies and escalates deviations to processes, materials and / or non-conforming incidents to manager upon discovery
Helps conduct investigations of process deviations and notifies production immediately of any problems that require their immediate attention to facilitate a timely completion (fresh in mind)
Assist in coordinating equipment maintenance and calibration
Provide necessary support to complete Annual product review
Provide necessary support to complete Annual retain sample inspection
Collection and submission of stability sample to QC
Perform other duties, special projects as assigned
Knowledge of basic or commonly used rules, procedures and operations, typically involving step-by-step instructions and required some previous training or experiences
Superior and proven written, verbal and interpersonal communication skills
Previous experience with Gram Staining and Incubation processes
Bachelor's degree in a life science or related field of study

QA Associate Resume Examples & Samples

SOP Management, including Document Control
Reviewing and where appropriate approving Trackwise PRs
Reviewing and where appropriate approving draft operational documentation. Performing Quality review of change controls
Responsible for status control of products/material
Assures compliance to ISO9001, company QMS and any other applicable regulations/standards
Assures compliance to MHRA regulations to ensure retention of MIA(IMP) and MS licenses
Assures compliance to HTA regulations to ensure retention of HTA license
Assures compliance to HFEA regulations to ensure retention of HFEA license
Performs required duties as an approved Archivist
Maintains QA metrics
Checking operational documentation for completeness, accuracy and adherence to Good Documentation Practices, where appropriate Quality approving documentation
Performs a QA related tasks as assigned by the Quality Manager
Performs QC functions as required
Travels as required
GMP experience is preferred

QA Associate Resume Examples & Samples

Education: High school diploma or G.E.D. (accredited)
Experience: Two years of relevant work experience
Call center or customer service experience required
Ability to cross train and develop others
Excellent verbal, written and analytical skills
Ability to multi task and to react well under pressure and treats others with respect
Work efficiently and effectively, both independently and as a team to ensure exceeding call center’s standards
Required to use motor coordination with finger dexterity (such as keyboarding, machine operation, etc) most of the work day
Required to be exposed to physical occupational risks (such as cuts, burns, exposure to toxic chemicals, etc) rarely

Senior QA Associate Resume Examples & Samples

Awareness of and familiarity with industry principles of quality assurance and quality management systems
Proficiency in global and local SOPs
Computer literate with expert knowledge of Quality database systems
Ability to negotiate and communicate with internal and external customers
Life science degree or pharmacy technician qualification (BTec or NVQ level 3 in Pharmaceutical Sciences)
Unique in our background and experiences

Senior QA Associate Resume Examples & Samples

Identify, test, and deliver enhancements needed by the business to the site Document Management system (Veeva) and the site Change Management System (selection process in progress)
Analyse, test and implement the multiannual Major version updates to the Veeva DMS ensuring all system documentation is maintained current
Create reports (Key Performance Indicator, Real Time, Dashboard) needed for executive, team and individual application users
Work with peers on all Alkermes sites and relevant steering committees on streamlining & harmonising common work practices and procedures
Function as Document Controller for changes relating to documentation, facility, utility, equipment and computerized system changes/upgrades to support site projects and the introduction of new products
Participate in QA projects where expertise and experience can be utilised e.g. internal and external audits, continuous improvement projects, migration of new document types to Veeva, generation of annual reports etc

QA Associate Resume Examples & Samples

Attending and participating in applicable company sponsored training
Attending educational workshops and reviewing professional publications
Participating in professional societies
Keeping informed of changes in the regulatory environment and/or regulatory requirements
Strong interpersonal, both verbal and written
Strong organizational and leadership skills
Goal oriented
3+ years experience in creating and maintaining SOPs preferred
3+ years current experience in a Regulatory or Quality Assurance role within the pharmaceutical industry
Proven ability to work with and direct teams to accomplish goals
Must be familiar with US and EU regulations and guidance

Nutrition QA Associate Resume Examples & Samples

Receive raw materials data and input into proprietary nutritional database
Generate 100g nutrition sheets for industrial customers
Ensure that data is accurate and compliant with FDA/USDA regulations

QA Associate Resume Examples & Samples

Raw material sampling
Creation and review of all Bulk Production Batch Records
Creation and review of all Finished Products Batch Records
Review and release of all Raw Materials

QA Associate Resume Examples & Samples

Provide exceptional customer service to Pacira’s internal and external customers in all assigned tasks
Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP)
Provide floor support for GMP activities
Monitor for GMP compliance of all in-process activities during GMP processing
Perform AQL particle inspection of in process product vials prior to packaging
Gown qualified for entry into controlled manufacturing areas and perform quality functions as assigned
Perform real time review of executed Batch Documentation and prepare for eventual disposition by QA management
Ability to search, document and generate Quality Event Reports for Batch Release with supervisor oversight
Organize documentation for Batch History Files
Assist with regulatory inspections and partner audits with supervisor oversight
Assist with the processing of DCR approval/review steps within MasterControl with supervisor oversight
Assist with Initiating /updating applicable Quality Standard Operating Procedures within MasterControl with management oversight
Contribute to/perform initial review of deviations of moderate complexity. Assign investigations as needed and assist in closure with minimal management oversight
Perform initiating/updating of Standard Operating Procedures within MasterControl with management oversight
Perform QA review/final approval of Deviation, OOS, CAPAs and NCMRs within MasterControl with minimal management oversight
Minimum 5 years of relevant Pharmaceutical Industry Quality Assurance experience
BS/BA degree in scientific discipline or equivalent experience
Prior experience with Batch Documentation review
Ability to manage multiple responsibilities with a high degree of self motivation

Senior QA Associate Resume Examples & Samples

Act as a point of contact for general queries relating to QA from customers and project teams
Draft, negotiate and complete quality agreements with customers
Act pro-actively towards external and internal customers
Support and host regulatory inspections and customer audits
Manage any outcomes/findings, ensure appropriate responses and escalate if necessary
Plan, execute the annual internal audit plan and for cause audits, report and escalate major and critical non-compliance issues
Provide QA support to initiate, participate and contribute to PQS process improvements initiatives and projects
Apply GMP regulations consistently and use knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement activities

QA Associate Compliance Resume Examples & Samples

Facilitates and manages the internal audit program
Schedules, coordinates, and conducts comprehensive GMP internal audits in accordance with written procedures and regulatory requirements
Develops detailed internal audit plans and prepares detailed audit reports
Develops recommendations for internal audit corrective actions/improvements and establishing timelines
Maintains an efficient corrective action tracking system to ensure regular follow-ups occur
Evaluates the effectiveness of corrective actions for closure
Performs regular walk-through audits of GMP areas
Leads the customer audit process
Hosts customer audits
Prepares document requests in accordance with customer audit agendas
Performs corrective action follow-ups to ensure that commitments to clients are completed as required
Independently conducts external supplier audits
Develops detailed audit plans and conducts comprehensive audits
Effectively summarizes audit activities within detailed reports
Assists with management of electronic quality management system processes
Creates, revises, and reviews SOPs
Trains new employees and other technical employees
Maintains GMP environment and follows SOPs
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practice

Sxl-field QA, Associate Specialist Resume Examples & Samples

Monitor and evaluate product quality through sampling and testing, as well as manage incoming product deliveries into Montello Terminal Tank Farm
Responsibilities include, taking product line and tank samples, performing laboratory testing on samples, evaluating test results to verify product quality and/or determine disposition of product
Direct incoming flow of products through HMI and manual pipeline valves. Conduct investigations of any product quality events or abnormalities
Communicate details of investigations and propose path forward to the Supervisor of Quality Assurance
Possess the ability to establish priorities, multitask and reshuffle workload based upon pipeline schedules. Perform duties independently with broad oversight from manager
mstr 30*

QA Associate Analyst Resume Examples & Samples

Desired understanding of software project life cycles
Working knowledge of Microsoft Office products (Word, Excel, PowerPoint, Outlook) and Internet Explorer
Knowledge of automation, defect tracking, metric software is desired
BS with 1 year experience directly related to the duties and responsibilities specified, or an equivalent combination of education and work experience
Detail oriented and a great communicator (both written and verbal) is required

QA Associate Resume Examples & Samples

1) Extract data from batch records and enter into client Enterprise resource planning system
2) Assist with authoring Standard Operating Procedures, Change Controls, and other related quality/technical documents
3) Assist with the evaluation of CAPAs as presented by Operations
4) Other Quality related duties as assigned
A minimum of 4 years of experience in a similar Quality Assurance role adhering to FDA guidelines
Previous experience with Annual Product Review reports is required
Technical writing experience (deviations/CAPAs/SOPs)

IT QA Associate Consultant Resume Examples & Samples

Ability to work in an international, virtual and highly diverse team
Excellent English skills (German could be a big plus)
Experience working in an Agile development environment, preferably SCRUM
0-20%

Senior QA Associate Resume Examples & Samples

BS/MS in Computer Science, Engineering or related degree 4+ years experience in QA role with automation systems Experience developing automated test suites using Selenium, MSTest or related tool suites
Strong understanding of methodologies for feature, regression, performance and load testing Excellent interpersonal and collaboration skills Able to build great working relationships Outstanding verbal and written communication skills Ability to articulate complex information to various audiences Experience with continuous integration practices and configuring build management systems such as Hudson/Jenkins, CruiseControl, etc
Strong knowledge of HTML, Java/Javascript, Web Services, XML and SQL Tactical experience as a software developer with compiled languages such as C++. C#, Java, etc. Exposure to Microsoft stack, Windows Server, SQL Server, TFS and Test Manager

QA Associate Resume Examples & Samples

Two years Medicaid or equivalent operations experience preferred
Two years quality assurance or equivalent experience preferred
Six Sigma or equivalent process improvement experience preferred
On-line documentation experience
Experience with the following programs is preferred

QA Associate Resume Examples & Samples

Review Batch records, deviations, investigations, documents, validation protocols, and reports compliance to internal and GMP standards
Maintains and monitors key quality systems such as: deviations, investigations, CAPA; which includes the review of trended data to identify areas for improvement
Conducts system and GMP training
Represent the department during client audits and FDA inspections, if needed
Write and revise Standard Operating Procedures (SOPs) as required
Provides guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities
Interacts with personnel from all departments of Johnson Matthey to ensure GMP compliance
Recommend the stop of manufacture and/or distribution of product if necessary
Review Master documents such as In-process forms and Batch Records
Approve stability study protocols, validation documents, test methods, and reference standards
Interact with contractor personnel regarding validation and qualification activities
Assist in the scheduling and maintenance of Quality Assurance activities and systems
Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7 and related guidance’s, FDA regulations, etc
Ensures site quality policies and procedures are compliant with state and federal requirements, including but not limited to GMP, DEA, FDA, etc
Must have API experience
Good understanding of Chemistry - supporting interaction credibility with Chemists
Degree in Chemistry of Physics
Previous experience working in analytical department
GMP QA experience

QA Associate Resume Examples & Samples

BS or MS degree in an appropriate scientific field
Membership/certification in SQA (Society for Quality Assurance) strongly preferred
Familiarity with regulatory requirements for laboratory-based immunogenicity studies
Experience working in a GLP and/or GMP regulated setting
Familiarity with cellular immune monitoring techniques preferred
Experience in immune monitoring of vaccine clinical trials or vaccine development preferred

QA Associate Resume Examples & Samples

Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk
Review, edit, or approve Regeneron controlled documents
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally
Ability to stand for periods of time when performing tasks on the floor
Requires BS/BA in scientific discipline or related field and 0-2 years relevant experience
Relevant experience may be substituted for education requirement

QA Associate Resume Examples & Samples

Assist in monitoring and assessing overall program performance
Ensure standards and procedures are adhered to and that services meet performance requirements
Ensure requirements are clearly established and the defined process complies with these requirements
Performs quality audits
Review the production of individual departments to ensure accuracy and compliance with contractual and internal standards
Compile weekly and monthly detail reports of departmental error rates for use by ACS Supervisory and Management Staff
Compile summary reports for client review
Review Test Plan against business requirements
Review test results against Test Plan and Business Requirements
Review system documentation against Business Requirements and Technical Specifications
Review CSR Checklist against established procedures
Review and monitor system physical or logical access for employees
May require a bachelor’s degree in area of specialty and 0-3 years of experience in the field or in a related area
Ability to compile and analyze data for variation and trends
Strong working knowledge of multiple computer applications
Excellent writing and verbal skills
Ability to handle multiple priorities, tasks and deadlines
Computer literate, skilled with Microsoft Excel and Word
Ability to handle multiple priorities and tasks
Ability to maintain strict confidentiality
Experience with Medicaid, Medicare, or Child Health Insurance (CHIP) programs

QA Associate Resume Examples & Samples

Knowledge in a Print and Mail production environment
Experience in Print Operations Quality Compliance
Must be able to multi-task while maintaining accuracy
Understand production Standard Operating Procedures
Experience using Microsoft Office products
Above average math skills, including excel

QA Associate Manager Resume Examples & Samples

Trend QTF project deliverables for Management
Minimum 5-8 years related experience in the pharmaceutical or biologics industry with emphasis on quality/project management
Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)
Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc
Strong team-oriented interpersonal skills are essential

QA Associate Resume Examples & Samples

Contributes to the successful completion of projects and works on small projects, progressing to working on multiple phases of a project
Provides input to test coverage, design specifications and defining conditions for given requirements
Resolves straight forward problems and escalates issues with suggestions for further investigation and options for consideration as required
Interprets, reviews, reports test activities and results in accordance with project plans
Understands business end-to-end processes and participates in production verification and validation
Maintains the status of project responsibilities and works across teams to achieve group goals
ISTQB Foundation
Additional course or certification in Quality Assurance
Fluency in German is a huge plus

Junior QA Associate Resume Examples & Samples

Contributes to the successful completion of projects. Works typically within low risk and low complexity projects
Uses a basic knowledge of quality assurance methodologies
Runs tests and retests as necessary, executing test scripts in area of accountability, reporting on test activities and results in accordance with project plans
Provides input into quality assurance plans, data, procedures, and scripts, assists in creating test cases and helps prepare for evaluations
Identifies test issues and reports risks, investigates defined issues
Plans and manages own time and work, contributing to overall ontime and on budget project goals
Maintains the status of project responsibilities and work across teams to achieve group goals
Takes ownership of own career development, demonstrating progress toward professional goals
Bachelor’s Degree in Computer Science, Information Systems, or other related field, or equivalent work experience

QA Associate Resume Examples & Samples

Conducts and reviews routine facility monitoring tasks
Writes, Review and process controlled documents
Maintains and creates QS tracking databases
Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements
Reviews production output batch records and assures that the proper procedures and processes have been used in the production of the products prior to approval by QA Manager. Assists QC in the review of product COA. Compile master production and control batch records
Initiate OOS/CAPA investigations, propose resolutions and process related forms
Assist in QS streamlining activities
Serve as department safety representative as directed by the QA Manger
Represents Quality Assurance function through interaction with Principal Investigators as directed by QA Manager
Maintains knowledge of current regulatory/accreditation requirements, changes and issues, inspection citations, quality assurance training, management, and organizational development activities
Wear a QS issued pager, or other communication devices, and promptly respond to all emergency calls for critical equipment failure at all times
Internal Contacts: Communicate with all manufacturing, QC and QS staff as it relates to document review & approval, master production and control batch record compilation, release test coordination, materials release/storage and facility/equipment maintenance issues. Conduct internal audits, follow-ups and write report for QAM or Senior QA Associate. Conduct internal cGMP and safety training. Train new QS personnel. Communicate with limited COH departments for project related issues. Present project updates at project meetings and to management as requested. Present routine updates at QS team meetings
External Contacts: Interact with external collaborators at project meetings and present project updates. Interact with other COH departments as directed. Communicate with external vendors as directed, to coordinate release tests activities and materials processing
Budget/Financial Administration: Track facility and project related costs (i.e. gowning supplies, process gases) for QA Manager or Senior QA Associate
May be required to archive documents
Bachelor of Science or Associate Degree with 3 - 5 years of experience
Minimum Experience: 3 – 5 years of experience
Required Courses/Training: Basic biology, chemistry, virology or engineering
Requirements, other: Foster and promote a positive image and professional appearance
Autonomous and self directed
Demonstrated laboratory skills
Knowledgeable about State and Federal regulatory requirements
Excellent writing skills required, including grammar and spelling. Able to correctly use technical terms and abbreviations
Preferred Education: Masters of Science with 0 – 4 years of experience
Preferred Courses/Training: Basic Biology (Molecular and Cellular) Chemistry (Inorganic, Organic and Biochemistry)
GMP facility operations
Biosafety courses, chemical safety, cGMP principles and practice, equipment maintenance
Preferred certification/licensure: Certification from ASQ or other professional organization /recognized institutions related to quality (i.e. quality auditor, quality manager, facility operations). Biotech sponsored seminars, workshops on regulations, policies, and procedures impacting cGMP/GLP activities related to biologics manufacturing
Preferred Field of Expertise: Biotechnology, Pharmaceutical industry experience

QA Associate Resume Examples & Samples

Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time
Perform room and equipment clearances per procedure following cleaning conducted by production
Perform microbial swabbing of equipment and room surfaces for environmental monitoring
Maintain a full understanding of all Catalent SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products
Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time
Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted
Must be flexible to shift work
Bachelor’s Degree in related science or technical field with 0-4 years work experience
Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment
Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification
Preferred understanding of GMP Manufacturing Environment
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you

Senior QA Associate Resume Examples & Samples

To represent quality and provide quality direction and input for site projects including New Product Introductions
To lead and participate in site quality projects
To review and approve SOPs, validation protocols, change requests, method deviations, reviews and Change Controls in accordance with company procedures and guidelines
To support the generation of technical agreements as required
To perform internal audits and host external customer audits as required
To assist in customer/regulator liaison, demonstrating our quality systems as required, and taking an active role in supporting the QPs
Assist the QPs in ensuring through relevant systems that regular audits, spot checks and self-inspections are completed; all legal requirements are met
To ensure that any tasks delegated are being performed to the required GMP and EU standards
Assist in conducting GMP training for the site for new employees. To perform any other reasonable duties as may be required by line management
To plan effective utilisation of your time/resource and prioritise activities to meet multiple project timelines
To be aware of and comply with regulatory and company requirements for all documentation
To ensure that all documentation is prepared to an acceptable standard according to Catalent Pharma Solutions, customer and regulatory requirements
Review and approval of regulatory requests

QA Associate Project Manager Resume Examples & Samples

Managing QTF project for both facilities to support the enhancements, harmonization, and improvements in Quality systems to ensure commercialization and EU readiness
Establishing, tracking and managing project schedule/critical path activities, status reporting, and resource plan development to ensure projects are completed on time and on schedule
Supporting QTF teams and providing guidance and support in their strategic function, as needed
Create the Quarterly Quality Newsletter, providing updates on QTF and other quality initiatives
Analytical and technical troubleshooting skills are a plus

QA Associate Resume Examples & Samples

Perform duty of care check prior to release or rejection of finished pharmaceutical products to the market and Investigational Medicinal Products for clinical studies
Support EU/EEA batch release for products imported from non EU/EEA countries. Ensure that the required documentation including Certificates of Analysis are received, reviewed and archived for all batches released for sale
Ensure that technical complaints concerning Novartis products are appropriately reported and investigated according to regulation and the Novartis Quality Manual. Assess technical complaint with possible impact on patient safety and/or with critical product defect
Contribute to maintenance of the local Nordic CPO Quality System including appropriate written Standard Operational Procedures (SOPs) concerning GMP including batch release, complaint handling and recalls etc. and act as Nordic SME in the roles set by Nordic QA LT
Ensure deviations concerning Novartis products and procedures are appropriately assessed, reported and investigated. Complete corrective and preventive actions and other obligations in due time
Participate in coordination of withdrawals and recalls including contact to health Authority
Ensure appropriate escalation of GMP/GDP related issues including critical complaints, potential counterfeits, potential recalls, critical product quality issues and Health Authority issues related to product compliance/quality etc. in accordance with internal Novartis procedures
Degree in Pharmaceutical Life Sciences or related fields
Min. 2 Years of experience from pharmaceutical industry, preferably within QA, QC. Qualification as Qualified Person can be considered as advantage

Senior QA Associate Resume Examples & Samples

Review and approval of completed batch records, records management support, and material disposition
Support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations
Review cGMP Controlled Documents such as SOPs, test methods, specifications and manages implementation of required changes to meet cGMP and internal standards

QA Associate, Document Control Resume Examples & Samples

Lead and perform the daily activities associated with document change management process, including document routing, distribution and storage, following all applicable SOPs,
With limited supervision, manage tasks to meet timelines for document processing in support of site operations
Serve as an administrator of the Electronic Document Management System (EDMS)
Create, review, approve, reject, renew, and cancel document change requests (DCRs), as needed
Ensure proper formatting of documents for the EDMS
Create/maintain efficient tracking systems for GMP documentation
Prepare and issue Master Batch Records to manufacturing
Issue and reconcile GMP logbooks
Perform the document periodic review process
Utilize the Records Management System (RMS) to manage hardcopy GMP documents submitted for retention and storage (both on-site and off-site); ensure timely retrieval of GMP records as needed
Assist project teams in multiple functional areas throughout the company in completing controlled documents in a timely manner to meet project and operational deadlines
Provide support for the site during inspections and internal audits
Participate on project teams as a department representative and as site representative on multi-site document team
Provide training to GxP employees on the Document Control system and procedures as required for their roles within the organization
BS/BA Degree preferred, 3+ years document control and/or training experience or equivalent work experience in a regulated environment (e.g., GMP, GCP, GLP)
Strong organization, problem-solving, and time management skills
Strong communication and interpersonal skills with the ability to interface at all levels
Thorough understanding and use of Microsoft Office Suite and Adobe Acrobat. Experience with electronic document management system and technical writing capabilities preferred
Ability to lift and move 40 lbs

QA Associate Resume Examples & Samples

Review of executed batch records in-process and release tests; and associated supporting documentation from clinical production areas, coordinate record correction activities related to batch release, data review, trending and release data reconciliation against Certificate of Analysis, specification and LIMS
Assist in preparation of lot release documentation for accuracy, GMP compliance, and validity. Support development of quality Standard Operating Procedures, their revision and perform additional QA related activities as assigned
This position will work closely with other QA associates to ensure that all compliance requirements are met in manufacturing, testing, completion of environmental monitoring data reviews, closure of deviations and change controls and availability of supporting documentation to ensure timely disposition of drug substance batches within the required cycle time
Support quality team members with facility routine and pre-operational walk through, equipment and room release functions and participate in internal audits as necessary to ensure compliance in GMP areas
Collecting metrics related to batch release functions and ensure meeting the required drug substance release cycle time
Work closely with cross-functional groups in resolving any discrepancies observed during the GMP documentation review and report any non conformance in the executed batch records or reviewed testing so they are addressed appropriately
Support investigations associated with manufacturing operations and analytical testing activities and may be rotated on the production floor to provide timely quality support and coaching to production operators during critical operations

QA Associate / QA Specialist Resume Examples & Samples

Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.). Activities may be on the floor or at a desk
Participate in investigations associated with raw materials or product
Perform status labeling of raw materials and product
Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Train and/or mentor junior employees, including providing insights and education on processes and procedures
Provides consultation or advice in alignment with QA policies
Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials
Understanding of biologics manufacturing operations is preferred
Ability to learn and utilize computerized systems for daily performance of tasks
Ability to prioritize, manage multiple tasks, and meet deadlines
Ability to stand for periods of time when performing tasks on the floor (Raw Materials)
Ability to lift up to 50 pounds (Raw Materials)
For QA Associate - Requires BS/BA in scientific discipline or related field and 0-2 years relevant experience. Relevant experience may be substituted for education requirement
For Associate QA Specialist - Requires BS/BA in scientific discipline or related field and minimum 2 years relevant experience. Relevant experience may be substituted for education requirement
For QA Specialist - Requires BS/BA in scientific discipline or related field and minimum 4 years relevant experience. Relevant experience may be substituted for education requirement

QA Associate Resume Examples & Samples

1-2 years QA experience
BS in Chemistry along with API experience
Identify issues and provide recommended results

QA Associate, Data Reviewer Resume Examples & Samples

Response for on-the floor review of Production Batch Records, Worksheets and Changeover Protocols utilized in cGMP manufacturing facility for accuracy and GMP compliance
Interact with Production personnel to resolve discrepancies and deviations
Work closely with Manufacturing to ensure document changes, deviations and CAPAs are performed in compliance with SOP’s cGMP regulations
Provide quality assurance support for internal projects as deemed necessary
Review changes to documents (including, but not limited to, SOPs and batch records), following established cGMP guidelines
Track and trend batch record review and related issues
Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation, Division and Location
Provide QA support for a variety of projects at the site.　 These projects can include putting procedures in place for new manufacturing areas, revisions to procedures for updated areas, assisting in implementation of new systems within the quality and regulatory arena, etc
BS in scientific discipline or equivalent with related experience
Minimum of 0 to 2 years’ experience in a cGMP-related field
Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, PowerPoint)
Batch record review experience and/or material inspection experience
This position is accountable for compliance to site, division and corporate procedures in his/her work area.　
Accountable for meeting established department standards and goals.　
Accountable for reviewing production batch records and addressing related issued

QA Associate Resume Examples & Samples

Reviews and accepts or rejects DHR and SLHR paperwork based on compliance levels
Work may involve processing OEM inspections or Product Return transactions
Performing QA permitted SAP transactions as required for the product movement
Data entry as necessary to track and trend quality metrics
Assist in preparation of monthly and quarterly metrics reviews
Authorizes and consults on any additional testing and information necessay to ensure accuracy, completion, and compliance with GMPs
Ensures timeple release of Sterile Loads
Interfaces with various internal entities such as Manufacturing, R&D, Quality, Shipping adn Supply Chain to assist with obtaining complete set of records to documentat manufacting process
Contributes to Internal Audits
Takes part in cross-functional and functional projects related to Product Release
Performs other responsibilities as required by the Quality System and duties assigned or requested
High School Diploma or equivalent and 0-1 years relevant experience
Success in this role entails having a candidate with very high attention to detail
Thorough knowledge of Good Manufacturing/Documentation Practices (GDP/GMP) and Boston Scientific company requirements
Candidate must be proactive in resolving any quality concerns or identified noncompliance
Skilled in performing SAP transactions as required for the product movement
Effective verbal and written communicator in describing identified quality compliance issues to varied cross-functions
Ability to flex in performing product release roles from M to D-plant. This includes product release roles from SUD (Sled, Drapes), OEM, IQA to D plant, and Manufacturing/Repair Ops
Cognitive skills in Capital Equipment product release requirements for both New Product Introduction/Acquisition and sustaining products

Clinical Lab QA Associate Resume Examples & Samples

Manage assigned clinical site labs for HVTN and client protocol preparation; includes provision of clinical site training, ensuring appropriate supplies on site, developing and communicating protocol-related lab practices, determining site equipment needs, and monitoring Good Clinical Laboratory Practice compliance
Assist clinical site labs with implementation of their tailored Quality Assurance plans, including but not limited to the writing and use of laboratory SOPs, establishment of equipment maintenance programs, and proper data and specimen management
Provide support, investigative consultation, and monitor effective resolution for clinical site laboratory testing, protocol issues and applicable quality system problems
Review and analyze clinical site labs’ workload, performance and adherence to approved Quality Assurance Program
Communicate as needed with Division of AIDS or DAIDs contractors
Provide clinical site lab support, training and protocol lab practice reviews through regular site visits, conference calls or other appropriate media; adapt communication styles based on targeted audience and topic
Provide oversight for Peripheral Blood Mononuclear Cell (PBMC)/serum/plasma processing and cryopreservation training and certification program
Provide PBMC External Quality Control (EQC) program support including analysis, interpretation and reporting to sites. Review adequacy of site response on EQC reports
Manage clinical site supply program including resourcing new supplies and vendors, monitoring site delivery system and oversight of invoices
Develop and implement clinical site training programs and tools for new specimen processing techniques that include quality assurance practices
Provide LDMS (centralized laboratory data management system) support to sites; provide program input to the program developer, Frontier Sciences
Provide input and support to HVTN and client protocol teams regarding local lab testing/methodologies, processing, storage and shipping of specimens
Provide input and support to for HIV/AIDS Network Coordination (HANC) lab programs, including the Lab Focus Group
Coordinate, participate and support the efforts of the HVTN Laboratory Program and perform additional activities as necessary
B.S/B.A. required – preferably in a scientific field with Minimum 5 years of experience in clinical safety laboratory
Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance
Certified medical technologist preferred
Experience in clinical safety laboratory management, PBMC (peripheral blood mononuclear cell) processing and storage and clinical trials preferred
Understanding of HIV diagnostics testing preferred
Computer skills – including Microsoft Word, Excel, PowerPoint and other laboratory-specific programs
Good numeracy, literacy and organizational skills
Good interpersonal and time management skills
Willingness to be flexible in working hours, be willing to travel as needed (up to 25%), and work some evenings and weekends

QA Associate / Batch Record Reviewer Resume Examples & Samples

Compile/organize documentation from Manufacturing, Packaging, and Laboratories
Initiate and participate in investigations
Initiate and participate in CAPAs
Resolve any paperwork discrepancies related to assigned tasks
Review/Approve manufacturing/packaging batch records
Revise customer’s specifications
Revise MARs
Notify QA Management of issues that require management input
Send notification when a specific batch of product can be shipped
File/Archive documentation
Assign, Reconcile, File logbooks and notebooks
Communicate with customers and project managers
Support QA Management with audits
Update spreadsheets related to assigned tasks
Other tasks may be assigned as deemed necessary by hiring manager
Bachelor’s degree in scientific discipline
Comply with all company policies, SOP’s cGMP and relevant regulatory requirements
Maintain training at or above 90% of assigned curriculum
Possess Good Documentation Practices
Possess a working knowledge of MS Office applications (word, excel, etc…)
Ability to work individually and in groups
Ability to perform basic math skills
Ability to read, write, and understand English
Meet deadlines as assigned
Ability to be cross trained in other QA functions as needed

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