QA Area Specialist II - API: Batch Release & Compliance

Novo Nordisk A/S; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Paid holidays

Healthy insurance

401K match

Parental leave

Tuition assistance

Life & disability insurance

Employee referrals

Job summary

Novo Nordisk in Clayton, NC is seeking a Quality Assurance Area Specialist II - API to review API batch reports, oversee minor changes and deviations, and drive quality processes on the shop floor. You will collaborate with QA to ensure GMP compliance and support continuous improvement in an API manufacturing setting.

The role requires a life sciences or engineering background and at least 3 years in QA within pharma, with strong knowledge of batch review and quality systems.

Qualifications

• Bachelor's degree or equivalent combination of education and work experience.
• 3+ years of QA or related experience in pharma/medical devices preferred.
• Understanding of cGMP manufacturing and production processes.
• Understanding of Batch review processes, quality oversight, and production support.
• Understanding of quality management systems and GMP regulations.
• Good stakeholder relations and workload prioritization.

Responsibilities

• Perform batch review activities for API materials release.
• Review API/Intermediate batch documentation in LIMs, SAP, NovoGlow, etc.
• Ensure site compliance with regulations, ISO standards, and SOPs.
• Review and approve minor change controls and low complex major changes.
• Review and approve minor deviations and low complexity major deviations.
• Provide guidance to departments on quality activities.
• Participate in root-cause analysis and process confirmations.
• Contribute to quality oversight on the shop floor.
• Act as an Authorized person per Novo Nordisk Quality Manual.
• Handle other accountabilities as assigned.

Skills

cGMP manufacturing

Batch review processes

Quality management systems

Quality oversight

Quality and production processes

Stakeholder relations

Prioritizing & workload management

Education

Bachelor's Degree in Life Sciences/Engineering or related field

3+ years QA or related experience

Job description

Novo Nordisk in Clayton, NC is seeking a Quality Assurance Area Specialist II - API to review API batch reports, oversee minor changes and deviations, and drive quality processes on the shop floor. You will collaborate with QA to ensure GMP compliance and support continuous improvement in an API manufacturing setting.

The role requires a life sciences or engineering background and at least 3 years in QA within pharma, with strong knowledge of batch review and quality systems.