QA Area Specialist I - SDF (2nd shift)
Novo Nordisk
August 19, 2026
On-site
Durham, NC
Operations
The Position:
- Ensure Batch Production Records (BPRs) and/or relevant quality processes comply with regulations and applicable SOPs and guidance.
- Accountable for Quality review and approval of Change Requests (CRs), Deviations, and other documentation.
- Perform Self Audits (with the line of business) and provide Quality Assurance presence/process confirmation on the shop floor.
- Ensure site compliance with regulations, ISO standards, and corporate/local SOPs.
- Review and approve quality documentation (batch records and other documentation).
- Support, review, and approve investigations and root-cause analysis using LEAN tools and continuous improvement.
- Participate in process confirmations and “Go Look Sees.”
- Evaluate trend/report data for QMRs and APR reports.
- Review and approve local production-related Customer Complaint Investigations (escalate if necessary).
- Support audit management during internal/external audits and inspections.
- Train AP and FP members conducting investigations.
- Follow all safety and environmental requirements.
Qualifications:
- Associate’s degree in life sciences or related field (required); Bachelor’s preferred.
- High School Diploma/GED with 6+ years QA/related quality experience may be considered.
- 2+ years QA and/or quality-related or API experience (preferably pharmaceutical industry) (required).
- Quality experience preferred; general pharmaceutical regulations and quality systems knowledge preferred.
- Knowledge of Quality and one or more: Aseptic Production, QC, Production Support, Warehousing/Transport, API, Finished Production (preferred).
- Excellent written/verbal communication; basic MS Office/MS Project/PowerPoint skills required.
Benefits (as listed):
- Leading pay and annual performance bonus; paid time off incl. 14 holidays; health/dental/vision effective day one; guaranteed 8% 401K contribution plus match; 14 weeks paid parental & 6 weeks paid family medical leave; free access to Novo Nordisk-marketed products; tuition assistance; life & disability; employee referral awards.
Application instruction (if accommodations needed): Call 1-855-411-5290 for accommodation requests only.
- Ensure Batch Production Records (BPRs) and/or relevant quality processes comply with regulations and applicable SOPs and guidance.
- Accountable for Quality review and approval of Change Requests (CRs), Deviations, and other documentation.
- Perform Self Audits (with the line of business) and provide Quality Assurance presence/process confirmation on the shop floor.
- Ensure site compliance with regulations, ISO standards, and corporate/local SOPs.
- Review and approve quality documentation (batch records and other documentation).
- Support, review, and approve investigations and root-cause analysis using LEAN tools and continuous improvement.
- Participate in process confirmations and “Go Look Sees.”
- Evaluate trend/report data for QMRs and APR reports.
- Review and approve local production-related Customer Complaint Investigations (escalate if necessary).
- Support audit management during internal/external audits and inspections.
- Train AP and FP members conducting investigations.
- Follow all safety and environmental requirements.
Qualifications:
- Associate’s degree in life sciences or related field (required); Bachelor’s preferred.
- High School Diploma/GED with 6+ years QA/related quality experience may be considered.
- 2+ years QA and/or quality-related or API experience (preferably pharmaceutical industry) (required).
- Quality experience preferred; general pharmaceutical regulations and quality systems knowledge preferred.
- Knowledge of Quality and one or more: Aseptic Production, QC, Production Support, Warehousing/Transport, API, Finished Production (preferred).
- Excellent written/verbal communication; basic MS Office/MS Project/PowerPoint skills required.
Benefits (as listed):
- Leading pay and annual performance bonus; paid time off incl. 14 holidays; health/dental/vision effective day one; guaranteed 8% 401K contribution plus match; 14 weeks paid parental & 6 weeks paid family medical leave; free access to Novo Nordisk-marketed products; tuition assistance; life & disability; employee referral awards.
Application instruction (if accommodations needed): Call 1-855-411-5290 for accommodation requests only.