Production Document Control Area Specialist - SDF; BULK

Location

Durham, NC, US

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies
-Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

• 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/Manager.

• Support continuous improvement within area
• Issue and track all batch related documentation
• Conduct real-time and post-execution batch reviews, including the evaluation of batch production records (BPRs), logbooks and related documentation, to ensure timely batch release and compliance with approved procedures and regulatory requirements
• Provide document support for Annual Product Review, Audit and Inspections and other requests as necessary
• Execute process confirmation for procedures related to Document Control
• Ensure site compliance with cGMPs, ISO standards corporate & local SOPs
• Follow all safety & environmental requirements in the performance of duties
• Other duties 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 college or university required and one (1) year of experience operating in a GMP regulated environment and two (2) years of experience of word processing & electronic document distribution
• In lieu of Associate’s Degree + one (1) year of experience operating in a GMP regulated environment and two (2) years of word processing and electronic document distribution experience, may consider a High School Diploma or equivalent with five (5) years of experience operating in a GMP regulated…