Quality Assurance Area Specialist I - Compliance & Impact

Novo Nordisk A/S; Durham (NC); Hybrid; USD 60,000 - 80,000; Full time

Benefits offered by this job

Health Insurance

14 paid holidays

Dental Insurance

Vision Insurance

401K contribution

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk is seeking a Quality Assurance Area Specialist I in Durham, NC. You will ensure batch records and quality processes comply with SOPs and regulations, review change requests and deviations, and participate in audits and investigations on the shop floor.

The role emphasizes QA oversight, CAPA activities, training of QA team members, and driving continuous improvement within a world‑class manufacturing environment.

Qualifications

• Associate degree in life sciences or related field; Bachelor’s preferred.
• Minimum QA-related experience; strong understanding of pharmaceutical regulations and quality systems.
• Knowledge of ISO standards and SOPs is preferred.

Responsibilities

• Ensure site compliance with regulations, ISO standards, and SOPs.
• Review and approve documentation for quality approval – batch records and related documents.
• Support investigations and root-cause analysis using LEAN tools and continuous improvement.
• Participate in process confirmations and Go Look Sees.
• Evaluate trends and report data for QMRs and APRs.
• Perform QA review/approval of local production related Customer Complaint Investigations.
• Support audit management during internal and external audits and inspections.
• Train AP and FP members responsible for investigations.
• Follow safety and environmental requirements in performance of duties.
• Other duties as assigned.

Skills

Quality reviews

LEAN tools

Go Look Sees

Investigations

Data analysis

Audits

Training

Education

Associate degree in life sciences

Bachelor's degree preferred

High School Diploma with 6+ years QA

Tools

MS Office

MS Project

PowerPoint

Job description

Novo Nordisk is seeking a Quality Assurance Area Specialist I in Durham, NC. You will ensure batch records and quality processes comply with SOPs and regulations, review change requests and deviations, and participate in audits and investigations on the shop floor.

The role emphasizes QA oversight, CAPA activities, training of QA team members, and driving continuous improvement within a world‑class manufacturing environment.