Senior Quality Assurance Area Specialist ; QA or IT & Automation

Position: Senior Quality Assurance Area Specialist I (QA or IT & Automation)
Location: Clayton

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  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 14 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 Reports to 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, Novo Glow, etc.)Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPsReview & approve change control requests

Review & approve deviationsguidance 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.

Physical Requirements 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 colour vision based on role. May require the ability to work in loud noise environments with hearing protections.

Qualifications Bachelor's Degree in Life Sciences, Engineering, or related field required

Minimum of five (5) years of…