Quality Assurance Associate (PA2025)
Job Description
Job Description
Location: Chapel Hill, NC (Onsite)
Contract Duration: 1 Year
Schedule: Full-Time
Are you passionate about quality systems, documentation, and ensuring compliance in a regulated manufacturing environment? We are seeking a Quality Assurance Associate to join our team in Chapel Hill, NC. This is an excellent opportunity for professionals with Quality Assurance experience in pharmaceutical, biotechnology, medical device, or GMP-regulated environments.
Key Responsibilities:
- Support Quality Assurance Systems under the direction of the QA Manager.
- Assist with document control, including creating, revising, approving, and archiving controlled documents.
- Issue and maintain batch records and supporting manufacturing documentation.
- Perform initial review of executed batch records and identify required corrections.
- Investigate deviations, document findings, and assist with corrective and preventive actions (CAPA).
- Support material release activities by inspecting incoming materials and verifying specifications.
- Track and trend manufacturing errors and quality metrics (KPIs).
- Assist with internal audits and monitor quality system performance.
- Develop and revise Standard Operating Procedures (SOPs), policies, forms, worksheets, and job aids.
- Support electronic Quality Management Systems (eQMS).
- Collaborate with manufacturing teams to ensure compliance with quality standards.
- Assist with validation documentation and review executed validation activities.
- Support training of QA/QC personnel on quality systems and procedures.
Qualifications:
- Bachelor's degree in Life Sciences, Biology, Chemistry, Quality, or a related field (preferred).
- Experience in Quality Assurance, Quality Control, or a regulated manufacturing environment.
- Knowledge of GMP, GDP, and quality systems.
- Experience reviewing batch records and manufacturing documentation.
- Strong documentation and technical writing skills.
- Excellent organizational, communication, and problem-solving skills.
- Proficiency in Microsoft Office.
- Experience with electronic Quality Management Systems (eQMS) is preferred.
- Experience with MasterControl is highly desirable.
Preferred Experience
- Pharmaceutical manufacturing
- Biotechnology
- Cell or Gene Therapy
- Medical Device Manufacturing
- FDA-regulated manufacturing
- CAPA and deviation investigations
- Internal auditing
- SOP development
- Validation documentation
Why Join Us?
- Competitive compensation
- One-year contract with the opportunity to gain valuable industry experience
- Collaborative and supportive work environment
- Opportunity to work with cutting-edge quality systems and manufacturing processes
- Career growth within a regulated life sciences environment
If you're ready to take the next step in your Quality Assurance career, we'd love to hear from you!
Apply today or explore additional opportunities on our website: https://www.techlinksystems.com/
Company DescriptionTechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.
We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.
Company Description
TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\n\r\nWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.