QA Compliance & Process Improvement Specialist

BioSpace; Durham (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Leading pay and annual performance 0mb

14 paid holidays

Health Insurance from day one

8% 401K company match

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk in Durham, NC seeks a QA professional to ensure batch records and related documentation meet regulatory standards. The role includes reviews, deviations, and investigations across the QA spectrum on the shop floor, with emphasis on continuous improvement.

The position requires 2+ years in QA, an associate degree in life sciences, and strong written/verbal communication. Allied training and safety compliance are integral to daily duties.

Qualifications

• Associate’s degree in life sciences or related field required.
• Bachelor’s degree preferred.
• Minimum of two (2) years QA and/or quality related experience, or API experience.
• General knowledge of pharmaceutical regulations and quality systems preferred.
• Knowledge of QA and at least one of: Aseptic Production, Production Support, QC, or API processes preferred.

Responsibilities

• Ensure site compliance with regulations and ISO standards.
• Review and approve documentation for Quality approval (batch records).
• Support investigations and root-cause analysis using LEAN tools.
• Participate in process confirmations and shop floor checks.
• Evaluate trend data for QMRs and APR reports.
• Review and approve local production related investigations.
• Assist audit management during internal and external audits.
• Train AP and FP members responsible for investigations.
• Follow safety and environmental requirements.
• Other duties as assigned.

Skills

Quality Assurance

Documentation

LEAN tools

Education

Associate degree in life sciences

Bachelor's degree preferred

Tools

MS Office

MS Project

PowerPoint

Job description

Novo Nordisk in Durham, NC seeks a QA professional to ensure batch records and related documentation meet regulatory standards. The role includes reviews, deviations, and investigations across the QA spectrum on the shop floor, with emphasis on continuous improvement.

The position requires 2+ years in QA, an associate degree in life sciences, and strong written/verbal communication. Allied training and safety compliance are integral to daily duties.