Quality Assurance Area Specialist III - QA IT / QC
Novo Nordisk
June 24, 2026
On-site
Clayton, NC
Operations
The Position
- Ensure plant systems batch release and/or relevant quality processes are compliant with regulations; provide product release authority if applicable.
- Provide quality oversight, review, and approval of validation activities and documents; maintain validated state of equipment/process/systems.
- Support audits and inspections with presentations, coaching, and QA shop-floor presence.
- Review and approve complex Change Requests (CRs), Deviations (DVs), CAPAs, and associated documentation.
- Conduct Self Audits (with assigned line of business); serve as Site Clayton Process Representative as assigned.
- Trend and report applicable quality data.
Essential Functions
- Make quality/compliance decisions with little guidance.
- Lead improvement activities and local implementations via process groups.
- Ensure site compliance with regulations, ISO/ISP standards, and corporate/local SOPs.
- Review and approve change control documentation and cGMP documentation (including SOPs).
- Coach site personnel on quality/compliance activities.
- Support and approve cross-functional investigations and root-cause analysis.
- Facilitate sharing of regulatory/compliance expectations.
- Review/approve complex DVs/CRs/trend & report data for CAPA, QMRs, and APR.
- Eliminate non-value-added practices; follow all safety and environmental requirements.
Qualifications
- High School Diploma or GED required.
- Bachelor’s in Life Sciences or relevant field: preferred; required for AQP.
- 7+ years QA/related quality experience in manufacturing, utility and/or packaging systems (pharma/medical device preferred).
- Demonstrated expertise in regulations and quality systems (e.g., DV/CAPA, change control, audits, validation, supplier/IT/w/ warehouse-logistics).
- Quality Risk Management experience required.
- Experience with 21 CFR Part 11, GAMP5, ISO, and data integrity required.
- Experience using risk and vendor assessments for change/deviation/validation required.
- Expert cGMP documentation practices (4+ years GMP document review preferred).
- Strong troubleshooting/root-cause skills.
- Excellent written/verbal communication.
- Auditing experience with certification preferred.
- LEAN/Six Sigma and continuous improvement required.
- Statistical methods knowledge required.
- Root-cause analysis tools/techniques and risk assessment/risk management expertise required.
Benefits (if explicitly stated)
- Leading pay and annual performance bonus; 14 paid holidays; health/dental/vision effective day one; 8% 401(k) contribution plus match; paid parental (14 weeks) and family medical leave (6 weeks); free access to Novo Nordisk-marketed products; tuition assistance; life/disability insurance; employee referral awards.
Application instructions
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodations only).
- Ensure plant systems batch release and/or relevant quality processes are compliant with regulations; provide product release authority if applicable.
- Provide quality oversight, review, and approval of validation activities and documents; maintain validated state of equipment/process/systems.
- Support audits and inspections with presentations, coaching, and QA shop-floor presence.
- Review and approve complex Change Requests (CRs), Deviations (DVs), CAPAs, and associated documentation.
- Conduct Self Audits (with assigned line of business); serve as Site Clayton Process Representative as assigned.
- Trend and report applicable quality data.
Essential Functions
- Make quality/compliance decisions with little guidance.
- Lead improvement activities and local implementations via process groups.
- Ensure site compliance with regulations, ISO/ISP standards, and corporate/local SOPs.
- Review and approve change control documentation and cGMP documentation (including SOPs).
- Coach site personnel on quality/compliance activities.
- Support and approve cross-functional investigations and root-cause analysis.
- Facilitate sharing of regulatory/compliance expectations.
- Review/approve complex DVs/CRs/trend & report data for CAPA, QMRs, and APR.
- Eliminate non-value-added practices; follow all safety and environmental requirements.
Qualifications
- High School Diploma or GED required.
- Bachelor’s in Life Sciences or relevant field: preferred; required for AQP.
- 7+ years QA/related quality experience in manufacturing, utility and/or packaging systems (pharma/medical device preferred).
- Demonstrated expertise in regulations and quality systems (e.g., DV/CAPA, change control, audits, validation, supplier/IT/w/ warehouse-logistics).
- Quality Risk Management experience required.
- Experience with 21 CFR Part 11, GAMP5, ISO, and data integrity required.
- Experience using risk and vendor assessments for change/deviation/validation required.
- Expert cGMP documentation practices (4+ years GMP document review preferred).
- Strong troubleshooting/root-cause skills.
- Excellent written/verbal communication.
- Auditing experience with certification preferred.
- LEAN/Six Sigma and continuous improvement required.
- Statistical methods knowledge required.
- Root-cause analysis tools/techniques and risk assessment/risk management expertise required.
Benefits (if explicitly stated)
- Leading pay and annual performance bonus; 14 paid holidays; health/dental/vision effective day one; 8% 401(k) contribution plus match; paid parental (14 weeks) and family medical leave (6 weeks); free access to Novo Nordisk-marketed products; tuition assistance; life/disability insurance; employee referral awards.
Application instructions
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodations only).