Production Document Control Area Specialist I - SDF (BULK) (Durham, NC, US)

About the Department

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.

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

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.

Relationships

Reports to Senior Manager/Manager.

Essential Functions

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

Support minor deviations

Follow all safety & environmental requirements in the performance of duties

Other duties as assigned

Physical Requirements

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).

Minimum Qualifications

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 environment, word processing and electronic document distribution

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

Proficiency with problem solving techniques required

Demonstrated experience using strong attention to detail, proofreading & strong computer skills with a willingness to learn new IT systems required

Excellent written & oral communication skills required

Ability to work in a team for batch reviews required

Preferred  Qualifications

Bachelor’s Degree Technology, Life Science, Pharma or a relevant field of study from an accredited university preferred

Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing preferred

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

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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