QA Area Specialist: Compliance & Process Assurance

BioSpace; Durham (NC); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive pay

Annual bonus

Paid time off

Insurance from day one

Retirement plan with company match

Parental leave

Tuition assistance

Life & disability insurance

Employee referral program

Job summary

Novo Nordisk in Durham, NC is seeking a Quality Assurance professional to ensure BPRs and related documentation meet regulations and SOPs. This role involves reviewing change requests, deviations, and performing on-floor QA presence and process confirmations.

You will participate in audits, investigate issues, and train junior staff while upholding safety and environmental requirements. The ideal candidate has QA experience in pharma and strong communication.

Qualifications

• Associate degree in life sciences or related field required; bachelor’s degree preferred.
• Minimum 2 years QA or quality related experience, preferably in the pharmaceutical industry.
• Knowledge of pharmaceutical regulations and quality systems preferred.
• Excellent written and verbal communication skills required.

Responsibilities

• Review and approve Batch Production Records and related documentation.
• Review and approve Change Requests and deviations under QA oversight.
• Participate in internal and external audits and inspections.
• Support investigations and root cause analysis using LEAN tools.
• Train AP and FP members in investigations and quality processes.
• Ensure compliance with regulations and SOPs on the shop floor.

Skills

QA experience

Regulatory knowledge

Documentation review

LEAN tools

Communication skills

Education

Associate's degree in life sciences or related field

Bachelor's degree preferred

Tools

MS Office

MS Project

PowerPoint

Job description

Novo Nordisk in Durham, NC is seeking a Quality Assurance professional to ensure BPRs and related documentation meet regulations and SOPs. This role involves reviewing change requests, deviations, and performing on-floor QA presence and process confirmations.

You will participate in audits, investigate issues, and train junior staff while upholding safety and environmental requirements. The ideal candidate has QA experience in pharma and strong communication.