QA Area Specialist II - SDF; 3rd shift

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes and obesity. Our three manufacturing facilities in North Carolina support the production of injectable and oral treatments for patients with type 2 diabetes.

• Leading pay and annual performance bonus
• Generous paid time off, including 14 paid holidays
• Health, dental, and vision insurance effective day one
• 8% 401(k) contribution plus company match option
• Family‑focused benefits, including 14 weeks of paid parental leave and 6 weeks of paid family medical leave
• Free access to Novo Nordisk–marketed pharmaceutical products
• Tuition assistance
• Life and disability insurance
• Employee referral awards

Perform quality review and approval of Batch Production Records (BPRs), Change Requests (CRs), deviations, and other documentation in conjunction with lines‑of‑business. Provide quality oversight, review and approval of validation activities associated with minor changes to existing systems. Perform archiving duties and assure QA presence and process confirmation on the shop floor.

Reports to the Manager, Quality Assurance.

• Ensure site compliance with regulations, ISO standards, corporate and local SOPs.
• Review and approve documentation for quality approval—components/raw material, batch records, change control requests, deviations, and validation documents.
• Perform QA presence and process confirmation on the shop floor.
• Participate in project teams as a quality resource.
• Support, review and approve investigations and root‑cause analysis.
• Participate in process confirmations and Go‑Look Sees.
• Evaluate trend and report data for QMRs and APR reports.
• Follow all safety and environmental requirements.
• Other duties as assigned.

• Move equipment or supplies weighing up to 33 pounds within the facility using various body positions.
• Be on feet for up to a 12‑hour shift.
• Corrected vision to 20/20 or 20/25 may be required.
• Color vision may be required.

• Bachelor’s degree in life sciences or related field from an accredited university (required).
• Associate’s degree with a minimum of five years of QA or related quality experience (considered).
• High school diploma or GED with a minimum of seven years of QA or related quality experience (considered).
• Minimum of three years of QA and/or quality‑related or API experience, preferably in the pharmaceutical industry (required).
• Understanding of cGMP manufacturing and production processes and how to apply required standards.
• Understanding of batch review processes.
• Understanding of validation (preferred).
• Understanding of quality management systems.
• Understanding of quality oversight and on‑floor production support.
• Knowledge of quality management systems.
• Demonstrated knowledge of critical controls and input/output requirements for NNPILP processes (preferred).
• Excellent written and verbal communication skills.
• Basic computer skills in MS Office, MS Project, PowerPoint, etc. (required).
• Auditing experience with certification (plus).
• Experience in the use of Six Sigma and LEAN tools (plus).

We commit to an inclusive recruitment process and equality of opportunity for all job applicants. Novo Nordisk is an equal‑opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by local, state, or federal laws, rules or regulations.