QA Area Specialist III - Finished Production (Validation Focus)

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 The Position 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. Relationships Reports to: Associate Director, QA Finished Production. Essential Functions 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 Qualifications 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 management required Time management, organizational & project management skills required Physical Requirements Moves equipment & supplies up to 33 pounds using various body positions; performs close precision work with hands; must remain stationary (sitting/standing) 50% of the time; may require corrected vision 20/20 or 20/25; may require color vision; may need to work in loud noise environments with hearing protection. We commit to an inclusive recruitment process and equality of opportunity for all job applicants. At Novo Nordisk, we’re not chasing quick fixes – we’re creating lasting change for long‑term health. For over 100 years, we’ve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. We embrace diverse perspectives, seek bold ideas, and build partnerships rooted in shared purpose. Together, we’re making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today. Novo Nordisk is an equal‑opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. #J-18808-Ljbffr Novo Nordisk