Production Document Control Area Specialist I - SDF (BULK)

Initial Therapeutics, Inc.; Durham (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

Novo Nordisk in Durham, NC, seeks a Document Control Specialist to provide routine support for batch documentation review and control. The role ensures SOPs and production records are maintained per internal and external requirements.

You will participate in continuous improvement of the batch review system and support audits and regulatory requests. The position requires an Associate’s degree with GMP experience, strong IT skills (Adobe, Excel, SAP), and excellent written and verbal

Qualifications

• Associate’s Degree in Technology, Life Science, Pharma or a relevant field plus GMP experience.
• Experience with documentation in pharmaceutical GMP environments and SOPs.
• Strong attention to detail and proficiency with IT systems.

Responsibilities

• Review batch documentation and SOPs for accuracy and completeness.
• Maintain and issue batch related documentation and records.
• Support audits and inspections with documentation packages.
• Ensure compliance with cGMPs, ISO standards, and local SOPs.
• Assist with process improvements and deviations as needed.

Skills

GMP knowledge

Documentation

Attention to detail

Problem solving

Written communication

Team collaboration

Education

Associate’s Degree in Technology, Life Science, Pharma or a relevant field

Bachelor’s Degree preferred

Tools

Adobe

Excel

SAP

Job description

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 USfacility 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 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

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.