API Quality Assurance Specialist II – Batch Release

Novo Nordisk A/S; Clayton, Northern (NC, KY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Leading pay and annual performance-bon

14 paid holidays

Health Insurance (medical, dental, and

Vision Insurance

401K with company match

Parental & family leave (14 weeks / 6)

Product access to Novo Nordisk meds

Tuition assistance

Life & disability insurance

Employee referral awards

Job summary

Novo Nordisk A/S is seeking a Quality Assurance Area Specialist II - API in Clayton, NC. The role focuses on batch review for API materials, deviations, change controls, and QA on the shop floor to assure quality outcomes.

You'll support process confirmations, root-cause analyses, and ensure adherence to Novo Nordisk Quality Manual. Strong collaboration with departments is essential for compliant manufacturing.

Qualifications

• Bachelor’s degree required in life sciences or engineering or related field.
• Minimum three years of QA or related experience in pharma or medical devices.
• Understanding of cGMP manufacturing and production processes.

Responsibilities

• Review batch reports for release of API materials.
• Review API/Intermediate batch documentation in LIMS, SAP, NovoGlow.
• Ensure site compliance with regulations and ISO standards.

Skills

Quality Assurance

GMP knowledge

Stakeholder relations

Prioritization

On-floor support

Root-cause analysis

Education

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

Equivalent combination of education & work experience

Tools

LIMS

SAP

NovoGlow

Job description

Novo Nordisk A/S is seeking a Quality Assurance Area Specialist II - API in Clayton, NC. The role focuses on batch review for API materials, deviations, change controls, and QA on the shop floor to assure quality outcomes.

You'll support process confirmations, root-cause analyses, and ensure adherence to Novo Nordisk Quality Manual. Strong collaboration with departments is essential for compliant manufacturing.