Quality Assurance Specialist: Batch Records & Compliance

NCBioImpact; Durham (NC); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Parental & family leave

Job summary

Novo Nordisk in Durham, NC is seeking a QA Associate to ensure Batch Production Records and related quality processes comply with SOPs and regulations. You will review Change Requests, Deviations, and investigations, and participate in self-audits with QA presence on the shop floor.

Reports to the QA Manager; role emphasizes LEAN-driven problem solving, data evaluation for QMRs, and training in investigations.

Qualifications

• Associate degree in life sciences or related field; bachelor’s preferred.
• Quality experience in QA/pharma environments is valued.
• Familiarity with quality systems and regulatory requirements beneficial.

Responsibilities

• Ensure Batch Production Records and QA documentation comply with SOPs.
• Review and approve Change Requests, Deviations, and investigations.
• Perform self-audits and support QA presence on the shop floor.
• Support investigations using LEAN tools and report data for QMRs.

Skills

QA

Regulations

LEAN

Documentation

Communication

Education

Associate degree in life sciences

Bachelor’s degree preferred

Tools

MS Office

MS Project

PowerPoint

Job description

Novo Nordisk in Durham, NC is seeking a QA Associate to ensure Batch Production Records and related quality processes comply with SOPs and regulations. You will review Change Requests, Deviations, and investigations, and participate in self-audits with QA presence on the shop floor.

Reports to the QA Manager; role emphasizes LEAN-driven problem solving, data evaluation for QMRs, and training in investigations.