Quality Assurance Area Specialist II API

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 825000 square-feet of state-of-the-art equipment and houses the Fermentation Recovery and Purification in the production of ingredients for Novo Nordisks innovative oral products. At API youll 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

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.

Relationships

Reports to Manager QA.

Essential Functions

• Perform activities related to Batch review
• Review 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 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

Physical Requirements

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.

Qualifications

• Bachelors 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
• Understanding of Quality & Production processes required
• Good stakeholder relations required
• Capable of prioritizing & managing workload required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and defeating diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.

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.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.