QA Area Specialist III - Finished Production (Validation Focus)
Novo Nordisk
August 17, 2026
On-site
Clayton, NC
Operations
The Position
- Support Finished Production with review of validation activities.
- Ensure plant systems batch release and/or quality processes comply with regulations; provide product release authority (if in batch release).
- Oversee, review, and approve validation activities/documents; maintain validated state of equipment, processes, and systems.
- Present and support audits and inspections.
- Review/approve complex Change Requests (CRs), Deviations (DVs), CAPAs, and related documentation.
- Conduct Self Audits (with LoB); provide QA presence and process confirmation on the shop floor.
- Serve as Site Clayton Process Representative (as assigned); support all department processes/functions.
- Trend and report data as applicable.
Essential Functions
- Make quality/compliance decisions with limited guidance.
- Ensure compliance with regulations, ISO/ISP standards, and SOPs.
- Lead improvement activities for assigned processes.
- Review/approve change control and cGMP documentation; coach site on quality/compliance.
- Support complex cross-functional investigations and root-cause analysis.
- Review/approve DVs/CRs/trends for CAPA, QMRs, and APR reports.
- Follow all safety/environmental requirements.
Qualifications
- High School Diploma/GED required.
- Bachelor’s in Life Sciences or relevant field preferred (required for AQP).
- 7+ years QA/quality in manufacturing (utilities/packaging preferred); GMP environment required.
- Quality Risk Management experience.
- Knowledge of 21 CFR Part 11, GAMP5, ISO, Data Integrity.
- Experience with risk assessment and vendor assessments; risk management.
- Expert cGMP documentation practices (4+ years preferred).
- Troubleshooting/root-cause expertise; strong written/verbal communication.
- Auditing experience preferred; LEAN/Six Sigma required; statistical methods knowledge required.
Benefits (explicitly listed)
- Leading pay/annual bonus; 14 paid holidays; health/dental/vision (day one); 8% 401K + match option; 14 weeks paid parental & 6 weeks paid family medical leave; tuition assistance; life & disability; referral awards.
Onsite schedule
- Monday–Friday onsite.
- Support Finished Production with review of validation activities.
- Ensure plant systems batch release and/or quality processes comply with regulations; provide product release authority (if in batch release).
- Oversee, review, and approve validation activities/documents; maintain validated state of equipment, processes, and systems.
- Present and support audits and inspections.
- Review/approve complex Change Requests (CRs), Deviations (DVs), CAPAs, and related documentation.
- Conduct Self Audits (with LoB); provide QA presence and process confirmation on the shop floor.
- Serve as Site Clayton Process Representative (as assigned); support all department processes/functions.
- Trend and report data as applicable.
Essential Functions
- Make quality/compliance decisions with limited guidance.
- Ensure compliance with regulations, ISO/ISP standards, and SOPs.
- Lead improvement activities for assigned processes.
- Review/approve change control and cGMP documentation; coach site on quality/compliance.
- Support complex cross-functional investigations and root-cause analysis.
- Review/approve DVs/CRs/trends for CAPA, QMRs, and APR reports.
- Follow all safety/environmental requirements.
Qualifications
- High School Diploma/GED required.
- Bachelor’s in Life Sciences or relevant field preferred (required for AQP).
- 7+ years QA/quality in manufacturing (utilities/packaging preferred); GMP environment required.
- Quality Risk Management experience.
- Knowledge of 21 CFR Part 11, GAMP5, ISO, Data Integrity.
- Experience with risk assessment and vendor assessments; risk management.
- Expert cGMP documentation practices (4+ years preferred).
- Troubleshooting/root-cause expertise; strong written/verbal communication.
- Auditing experience preferred; LEAN/Six Sigma required; statistical methods knowledge required.
Benefits (explicitly listed)
- Leading pay/annual bonus; 14 paid holidays; health/dental/vision (day one); 8% 401K + match option; 14 weeks paid parental & 6 weeks paid family medical leave; tuition assistance; life & disability; referral awards.
Onsite schedule
- Monday–Friday onsite.