QA Area Specialist III - Finished Production (Validation Focus)

Role: QA Validation Specialist supporting finished production at Novo Nordisk's aseptic manufacturing site, focusing on validation review, batch release, and quality oversight. Responsibilities: review and approve validation activities, change requests, deviations, CAPAs, and related documentation; ensure compliance with GMP, regulations, and quality standards; lead process improvement initiatives; support audits and inspections; perform self-audits and report data trends. Requirements: high school diploma or GED; at least 7 years of QA or related experience in pharmaceutical manufacturing; expertise in GMP documentation, validation, risk management, and regulatory requirements (21 CFR Part 11, GAMP5, ISO); strong troubleshooting, communication, and project management skills. Preferred: bachelor’s degree in Life Sciences or relevant field; experience with LEAN, Six Sigma, and advanced validation areas (sterilization, utilities); auditing certification. HighValue: aseptic fill and finish manufacturing, validation review, batch release authority, GMP compliance, validation, risk management, sterile injectable production, onsite role, Monday–Friday.