QA Area Specialist III - Finished Production; Validation Focus
Listed on 2026-06-26
-
Quality Assurance - QA/QC
Quality Engineering, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist
About the Department
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic “fill and finish” site that produces innovative injectable diabetes and obesity treatments.
What We Offer You- Leading pay and annual performance bonus for all positions
- Generous paid time off including 14 paid holidays
- Health, Dental & Vision Insurance effective day one
- Guaranteed 8% 401(k) contribution plus company match option
- Family focused benefits including 14 weeks paid parental leave and 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition assistance
- Life & Disability Insurance
- Employee referral awards
This role supports our Finished Production area with a focus on review of validation activities. It ensures plant systems batch release, and/or relevant quality processes are compliant with regulations. The individual may have product release authority for batch release, perform quality oversight, review & approval of validation activities and documents, support audits and inspections, review and approve complex Change Requests (CRs), Deviations (DVs), CAPAs, and other documentation.
The role provides self audits in conjunction with line of business, QA presence on the shop floor, and site Clayton process representation. The position requires prior experience in a GMP environment and is onsite Monday‑Friday.
Reports to:
Associate Director, QA Finished Production.
- Make decisions on quality & compliance issues with little guidance
- Participate in process group activities and lead local implementations
- Ensure site compliance with regulations, ISOISP standards, corporate & local SOPs
- Lead improvement activities and improve standards within the assigned process
- Review and approve change control documentation, SOPs & other cGMP documentation
- Provide coaching to site regarding quality & compliance activities
- Support, review & approve complex cross‑functional investigations & root‑cause analysis
- Facilitate sharing of regulatory & compliance expectations
- Review & approve complex DVs, CRs, trend & report data for CAPA, QMRs & APR reports
- Eliminate non‑value‑added practices
- Follow all safety & environmental requirements
- Other accountabilities as assigned
- High School Diploma or equivalent (GED) required
- Bachelor’s degree in Life Sciences or a relevant field preferred; if hired as an AQP, required
- Minimum seven (7) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems, preferably in the pharmaceutical or medical device field
- Expertise in regulations & quality systems in areas such as product disposition, DV/CAPA, change control, audits, supplier management, project management, validation, laboratory method & equipment validation, warehouse/logistics, and IT preferred
- Quality Risk Management experience required
- Experience with regulatory requirements such as 21 CFR Part 11, GAMP5, ISO, data integrity required
- Experience in risk assessment & vendor assessments for change controls, deviations and validation activities required
- Expert in cGMP documentation practices; minimum four (4) years of experience reviewing GMP documents for compliance preferred
- Excellent troubleshooting skills; able to identify root cause of problems required
- Knowledge of critical controls & input/output requirements for semi‑finished manufacturing, finished manufacturing QC, IT & process utilities preferred
- Excellent written & verbal communication skills required
- Auditing experience with certification preferred; required
- Experience with LEAN, Six Sigma and other continuous improvement methodologies required
- Expert competence in core validation areas (sterilization, packaging, cleaning, utilities, process, or computer validation) preferred
- Knowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.) required
- Expert in root‑cause analysis tools & techniques preferred
- Experience with risk assessment & risk…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).