QA Area Specialist: Batch Records & Compliance

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

Benefits offered by this job

14 paid holidays

Health Insurance

Dental Insurance

Vision Insurance

8% 401K company match

Family focused benefits

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk in Durham, NC seeks a QA professional to ensure batch production records and related quality documentation comply with SOPs and regulations. You will review change requests, deviations, and other records, and participate in audits and investigations to drive continuous improvement.

Ideal candidates have at least 2 years in QA within pharma, strong communication, and a quality-focused mindset. This full-time role includes comprehensive benefits and opportunities for professional

Qualifications

• Associate’s degree in life sciences or related field required; bachelor’s degree preferred.
• High School Diploma or GED with 6+ years QA experience acceptable.
• Minimum 2+ years QA/quality related experience in pharma preferred.

Responsibilities

• Review and approve documentation for Quality approval—batch records and related docs.
• Support and approve investigations & root-cause analyses using LEAN tools.
• Participate in Go Look Sees and process confirmations.
• Evaluate trends for QMRs & APR reports.
• Participate in internal/external audits and inspections.

Skills

Communication skills

Quality mindset

Education

Associate’s degree in life sciences or related field

Bachelor’s degree preferred

High School Diploma or GED with 6+ years QA experience

Tools

MS Office

MS Project

PowerPoint

Job description

Novo Nordisk in Durham, NC seeks a QA professional to ensure batch production records and related quality documentation comply with SOPs and regulations. You will review change requests, deviations, and other records, and participate in audits and investigations to drive continuous improvement.

Ideal candidates have at least 2 years in QA within pharma, strong communication, and a quality-focused mindset. This full-time role includes comprehensive benefits and opportunities for professional