Quality Assurance Area Specialist III (QA for QC)

What We Offer You:
- Leading pay and annual performance bonus
- 14 paid holidays and generous paid time off
- Health, dental, vision insurance (effective day one)
- 8% 401(k) contribution plus individual company match option
- 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition assistance; life & disability insurance; employee referral awards

The Position:
- Ensure plant systems batch release and/or quality processes comply with regulations (and provide product release authority if applicable).
- Provide quality oversight: review/approve validation activities and documents; maintain validated state of equipment/processes/systems.
- Support audits/inspections (present, coach).
- Review/approve complex Change Requests, Deviations, CAPAs, and related documentation.
- Perform self-audits; provide QA presence/process confirmation on shop floor.
- Serve as Site Clayton Process Representative (as assigned); support all department processes; trend and report data as applicable.

Essential Functions:
- Make quality/compliance decisions with little guidance.
- Ensure site compliance with regulations, ISO standards, and SOPs.
- Lead improvements and standards within assigned process.
- Review/approve change control and cGMP documentation.
- Coach site on quality/compliance.
- Support cross-functional investigations and root-cause analysis.
- Facilitate sharing regulatory/compliance expectations.
- Review/approve complex DVs/CRs/trends for CAPA, QMR, and APR reports.
- Eliminate non-value-added practices; follow safety/environment requirements.

Qualifications:
- High school diploma/GED required.
- Bachelor’s in Life Sciences or relevant field: preferred; required if hired as an AQP.
- 7+ years QA and/or related quality experience in manufacturing/utility/packaging (pharma/medical device preferred) required.
- Quality Risk Management required.
- Regulatory/computer system experience: 21 CFR Part 11, GAMP5, ISO, data integrity required.
- Experience with risk assessment & vendor assessments required.
- Expert cGMP documentation practices; 4+ years GMP document review preferred.
- Excellent troubleshooting (root cause) required.
- Excellent written/verbal communication required.
- Auditing experience (internal/external) preferred.
- LEAN/Six Sigma/continuous improvement required.
- Statistical methods knowledge required (e.g., sampling/trending/CpK).
- Risk assessment/management required.
- Time management/organizational/project management excellence required.
- Root-cause analysis tools/techniques preferred; expertise in validation areas preferred.