Quality Assurance Specialist – Batch Records & Compliance

BioSpace; Durham (NC); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Paid holidays

Health insurance

401K with match

Parental leave

Tuition assistance

Life & disability insurance

Referral program

Job summary

Novo Nordisk in Durham, NC is seeking a QA professional to ensure batch records and related quality processes meet SOPs and regulatory standards. You will review documentation, support investigations, and participate in audits to drive continuous improvement.

The role requires QA experience in pharma, understanding of ISO regulations, and strong written communications. It is a 12-hour B shift with comprehensive benefits and growth opportunities within a global healthcare leader.

Qualifications

• Associate’s degree in life sciences; Bachelor’s preferred.
• Minimum of two years QA experience in pharmaceutical quality.
• High school diploma with six years QA experience considered.

Responsibilities

• Ensure site compliance with regulations, ISO standards and SOPs.
• Review/approve documentation for QA and batch records.
• Support investigations and root-cause analysis using LEAN tools.
• Participate in process confirmations and Go Look Sees.
• Evaluate trends for QMRs and APR reports.
• Review/approve customer complaint investigations as needed.
• Support internal/external audits and inspections.
• Train AP/FP staff responsible for investigations.
• Follow safety and environmental requirements in duties.
• This role is a 12-hour B shift position.
• Other duties as assigned.

Skills

QA experience

LEAN tools

Documentation review

MS Office

Education

Associate’s 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 professional to ensure batch records and related quality processes meet SOPs and regulatory standards. You will review documentation, support investigations, and participate in audits to drive continuous improvement.

The role requires QA experience in pharma, understanding of ISO regulations, and strong written communications. It is a 12-hour B shift with comprehensive benefits and growth opportunities within a global healthcare leader.