QA Area Specialist II - API: Batch Review & Compliance

Novo Nordisk A/S; Powhatan (NC); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Leading pay and annual performance bon

14 paid holidays

Health Insurance

Dental Insurance

Vision Insurance – effective day one

8% 401K contribution with company-math

Parental & family medical leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk A/S in Clayton, NC is seeking a Quality Assurance Area Specialist II - API to review batch reports for release, manage deviations, and ensure compliance across QA processes on the shop floor.

This role reports to the QA Manager and requires a life sciences degree and QA experience; Novo Nordisk offers competitive pay, 14 holidays, health/dental/vision, 8% 401K match, family leave, tuition assistance, life & disability insurance, and referral awards.

Qualifications

• Bachelor's Degree in Life Sciences, Engineering, or related field or equivalent combination of education & work experience required
• Minimum of three (3) years of QA or related experience in the pharmaceutical or medical device industry preferred
• Understanding of cGMP manufacturing & production processes & how to apply required
• Understanding of the Batch review Processes preferred
• Understanding of quality management systems preferred
• Understanding of quality oversight & on floor production support preferred

Responsibilities

• Perform activities related to Batch review
• Review API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
• Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
• Review & approve minor change control requests & low complex major change controls
• Review & approve minor deviations & low complexity major deviations
• Provide guidance to departments regarding quality & related activities
• Participate & provide input to root-cause analysis
• Participate in process confirmations & quality oversight
• Authorized person according to Novo Nordisk Quality Manual
• Other accountabilities, as assigned

Skills

QA experience

cGMP knowledge

Root-cause analysis

On-floor production support

Education

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

Job description

Novo Nordisk A/S in Clayton, NC is seeking a Quality Assurance Area Specialist II - API to review batch reports for release, manage deviations, and ensure compliance across QA processes on the shop floor.

This role reports to the QA Manager and requires a life sciences degree and QA experience; Novo Nordisk offers competitive pay, 14 holidays, health/dental/vision, 8% 401K match, family leave, tuition assistance, life & disability insurance, and referral awards.