Production Document Control Specialist

Novo Nordisk A/S; Durham, Northern (NC, KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K Plan

Paid time off including holidays

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Employee referral awards

Job summary

Novo Nordisk A/S in Durham, NC is seeking an experienced Batch Documentation & Control Specialist to support production operations. You will review batch records and SOPs, ensure timely documentation, and contribute to continuous improvements in the batch review system.

The role requires GMP experience, strong attention to detail, and proficiency with SAP, Excel, and Adobe. On-site work with standard benefits accompanies this full-time position.

Qualifications

• Associate degree plus GMP environment experience required.
• Experience with batch reports, SOPs and documentation.
• Good knowledge of regulatory expectations (FDA).
• Proficient with IT systems like Adobe, Excel and SAP.

Responsibilities

• Issue and track batch-related documentation.
• Conduct batch reviews of production records and logs.
• Support Annual Product Review and inspections requests.
• Ensure compliance with site cGMPs and SOPs.
• Provide document control support and process improvements.
• Follow safety and environmental requirements.

Skills

GMP knowledge

Documentation review

Attention to detail

Team collaboration

Troubleshooting

Education

Associate’s Degree in Technology, Life Science, Pharma

Alternative with 5 years GMP experience

Tools

Adobe

Excel

SAP

Document control systems

Job description

Novo Nordisk A/S in Durham, NC is seeking an experienced Batch Documentation & Control Specialist to support production operations. You will review batch records and SOPs, ensure timely documentation, and contribute to continuous improvements in the batch review system.

The role requires GMP experience, strong attention to detail, and proficiency with SAP, Excel, and Adobe. On-site work with standard benefits accompanies this full-time position.