Quality Assurance Area Specialist II - API; Clayton, NC,

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. 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 newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

• 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.

Main duties include review of batch reports for release of API materials, minor deviations, minor change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.

Reports to Manager, QA.

• Perform activities related to Batch review
• Review API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, Novo Glow, etc.)
• Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
• Review & approve minor change control requests & low complex major change controls
• Review & approve minor deviations & low complexity major deviations
• Provide guidance to departments regarding quality & related activities
• Participate & provide input to root-cause analysis
• Participate in process confirmations & quality oversight
• Authorized person according to Novo Nordisk Quality Manual
• Other accountabilities, as assigned

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder.

May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

• Bachelor's Degree in Life Sciences, Engineering, or related field or equivalent combination of education & work experience required
• Minimum of three (3) years of QA or related experience in the pharmaceutical or medical device industry preferred
• Understanding of cGMP manufacturing & production processes & how to apply required
• Understanding of the Batch review Processes preferred
• Understanding of quality management systems preferred
• Understanding of quality oversight & on floor production support preferred
• Strong written & verbal communication skills required
• Strong computer skills in MS Office, PowerPoint, Word, Excel, etc required
• Understanding of cGMPs in pharmaceutical manufacturing required
• Understand in…