Quality Assurance Area Specialist I or II (QA for FP
Listed on 2026-08-08
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Quality Assurance - QA/QC
Quality Engineering, Production QC/QA, Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
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Facility:
Quality
Location:
Clayton, NC, US
About the Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Ensure Batch Production Records (BPRs) and/or relevant quality processes are compliant with regulations and/or relevant standard operating procedures (SOP's) and guidance. Accountable for Quality review & approval of Change Requests (CR's), Deviations & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor.
Relationships
Reports to Senior Manager.
Essential Functions
- Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs
- Review & approve documentation for Quality approval – batch records and other documentation
- Support, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement
- Participate in process confirmations & Go Look Sees
- Evaluate trend & report data for Quality Management Reviews (QMRs) & Annual Product Review(APR) reports
- Perform QA role to review and approve local production related Customer Complaint Investigations (escalate if necessary)
- Participate in & support the audit management team as needed during internal, external audits and inspections
- Responsible for training of AP and FP members responsible for conducting investigations
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned
Physical Requirements
0-10% overnight travel required. May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.
Qualifications
- High School Diploma or equivalent (GED) required
- Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university preferred
- Minimum of two (2) years of pharmaceutical or medical device experience with progressively increasing responsibility required
- Quality Experience preferred
- General knowledge of pharmaceutical regulations & quality systems preferred
- Familiarity with local processes & quality systems preferred
- Knowledge of Quality and one or more of the following:
Aseptic Production, Business Support, QC, Production Support, Warehousing/Transport, and/or Finished Production processes preferred - Knowledge of Good Manufacturing Practices (GMPs) in related area required
- Basic computer…
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