QA Area Specialist I: Pharma Quality & Compliance

Novo Nordisk; Durham (NC); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Paid time off

Holiday pay

Health dental vision from day one

401K with company match

Parental & family leave

Tuition assistance

Life & disability insurance

Referral bonuses

Job summary

Novo Nordisk in Durham, NC seeks a QA professional to ensure batch records and related quality processes comply with SOPs and regulations. You will review change requests, deviations, and participate in audits while supporting investigations and LEAN improvements.

The role reports to the QA Manager and involves a 12-hour B shift. Candidates should have 2+ years in pharma QA, with strong communication and documentation skills.

Qualifications

• Associate degree in life sciences or related field required; bachelor preferred.
• Minimum two years QA or quality experience in pharma recommended.
• General knowledge of pharmaceutical regulations and quality systems preferred.
• Knowledge of QA in aseptic production, QC, API or finished production processes preferred.
• Excellent written and verbal communication skills required.

Responsibilities

• Ensure site compliance with regulations, ISO standards and SOPs.
• Review and approve documentation for quality approvals (batch records).
• Support investigations and root-cause analysis using LEAN tools.
• Participate in process confirmations and Go Look Sees.
• Evaluate data for QMRs and APR reports.
• Review and approve customer complaint investigations.
• Assist audit management during internal and external audits.
• Train AP and FP personnel responsible for investigations.
• Follow all safety and environmental requirements.
• This role is a 12 hour B shift position.
• Other duties as assigned.

Skills

Excellent written and verbal comms

MS Office

MS Project

PowerPoint

Education

Associate’s degree in life sciences

Bachelor’s degree preferred

Tools

MS Project

PowerPoint

Job description

Novo Nordisk in Durham, NC seeks a QA professional to ensure batch records and related quality processes comply with SOPs and regulations. You will review change requests, deviations, and participate in audits while supporting investigations and LEAN improvements.

The role reports to the QA Manager and involves a 12-hour B shift. Candidates should have 2+ years in pharma QA, with strong communication and documentation skills.