Senior Quality Assurance Area Specialist I (Onsite/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 life-changing careers, and 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.  

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 12 weeks 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

Responsible for the production activities & validation. Ensures relevant compliance issues are addressed & handled in close collaboration with production. Main duties include review of batch reports & release of API materials, deviations, change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.

Relationships

Manager, Quality Assurance.

Essential Functions

• Ensure that the current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions
• Support validation projects in communicating Novo Nordisk project quality requirements & assessing suppliers’ ability to support test/qualification activities to ensure that Novo Nordisk requirements & expectations are clear
• Support projects in solving quality related issues, act quickly in order to come to a decision, & communicate quickly & clearly regarding such decisions
• Support evaluation of the quality level during the project by performing spot checks of validation documentation
• Perform activities related to Batch review & release
• Review & approve API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
• Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
• Review & approve change control requests
• Review & approve deviations
• 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
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