Quality Assurance Area Specialist III - Finished Production

Location

We operate pharmaceutical manufacturing facilities in North Carolina. The Product Supply Aseptic Manufacturing (PS AM) facility is located in Clayton, NC and is a 457,000‑square‑foot, aseptic "fill and finish" site that produces innovative injectable diabetes and obesity treatments.

• Leading pay and annual performance bonus for all positions
• Generous paid time off including 14 paid holidays
• Health, dental, and vision insurance effective day one
• 8% 401(k) contribution plus company match option
• Family focused benefits, including 14 weeks paid parental and 6 weeks paid family medical leave
• Free access to Novo Nordisk‑marketed pharmaceutical products
• Tuition assistance
• Life and disability insurance
• Employee referral awards

This role performs general QA compliance activities for the Finished Production unit, ensuring plant systems batch release and relevant quality processes comply with regulations. The candidate has product release authority if the role is in batch release, oversees validation activities and document approvals, supports and coaches audit and inspection readiness, reviews change requests, deviations, CAPAs, and performs line‑of‑business self‑audits. The position is onsite at Clayton, NC, Monday to Friday.

Reports to:

Associate Director, QA Finished Production.

• Make decisions on quality and compliance issues with little guidance
• Participate in process group activities and lead local implementations
• Ensure site compliance with regulations, ISO:
  
  ISP standards, corporate and local SOPs
• Lead improvement activities and raise standards within the assigned process
• Review and approve change control documentation, SOPs, and other cGMP documents
• Provide coaching to site staff on quality and compliance activities
• Support, review, and approve complex cross‑functional investigations and root‑cause analysis
• Facilitate sharing of regulatory and compliance expectations
• Review and approve complex deviations, change requests, trends, and reports for CAPA, QMRs, and APRs
• Eliminate non‑value‑added practices
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities as assigned

• High school diploma or equivalent (GED) required
• Bachelor’s degree in Life Sciences or a relevant field from an accredited university preferred; if hired as an AQP, a bachelor’s degree is 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
• Demonstrated expertise in regulations and quality systems in one or more of the following: product disposition, DV/CAPA, change control, audits, supplier management, project management, validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred
• Quality risk management experience required
• Experience with regulatory requirements such as 21 CFR Part 11, GAMP 5, ISO, data integrity required
• Experience in risk assessment and vendor assessments during change control, deviation and validation activities required
• Expert in cGMP documentation practices; minimum four (4) years of reviewing GMP documents for compliance purposes preferred
• Excellent troubleshooting skills and root‑cause identification required
• Knowledge of critical controls and input/output requirements for semi‑finished manufacturing, finished manufacturing QC, IT, and process utilities preferred
• Excellent written and verbal communication skills required
• Auditing experience with certification preferred (internal/external) required
• Experience with LEAN, Six Sigma, and other continuous improvement methodologies required
• Expert competence in one or more 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 appropriate root‑cause analysis tools and techniques preferred
• Experience with risk assessment and risk management required
• Demonstrated excellence in time management, organizational, and project management skills required