Production Document Control Area Specialist

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.

Provide routine support & troubleshooting for the batch & documentation review process in production operations. Ensure that batch documentation as well as SOPs & other standardized documentation from production is maintained in accordance with internal & external requirements. Follow-up on and trouble-shoot challenges/ clarifications needed to ensure high-quality batch review. Participate in the continuous improvement of the batch review system to support production plans.

Meet or exceed customer, business & regulatory requirements in accordance with Novo Nordisk Way.

Reports to Senior Manager.

• Participate in the continuously improve of Purification, Recovery & Fermentation supporting documentation processes
• Execute batch review & documentation processes in operations
• Support Annual Process Review (APR) documentation & SOP reviews
• Ensure real time review to include BPR, logbooks, etc.
• Ensure site compliance with cGMPs, ISO standards corporate & local SOPs
• Review & approve, in a timely manner, executed batch production records (BPRs) ensuring accurateness & compliance with approved procedures & regulations
• Generate ideas for improvement within area & support implementation of ideas
• Ability to work in a team for batch reviews
• Support minor deviations
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities as assigned

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

• Associate’s Degree in Technology, Life Science, Pharma or a relevant field of study from an accredited university required
• May consider a High School Diploma or equivalent with five (5) years of experience operating in a GMP regulated environment required
• Bachelor’s Degree Technology, Life Science, Pharma or a relevant field of study from an accredited university preferred
• Minimum one (1) year of experience operating in a GMP regulated environment required
• Minimum two (2) years of word processing & electronic document distribution required
• Experience with documentation in the pharmaceutical industry, like batch reports, SOPs, etc. required
• Demonstrated knowledge of requirements/expectations of regulatory authorities e.g. FDA required
• Experience with IT systems, e.g. Adobe, Excel, SAP, material control systems, etc. required
• Proficient with problem solving techniques required
• Demonstrated experience using strong attention to detail,…