Production Document Control Area Specialist I - SDF (BULK)

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
• Support minor deviations
• 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 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

• 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.