QA Batch Review Specialist II

BioSpace; Clayton (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

8% 401K company match

Paid holidays

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk in Clayton, NC, is seeking a QA Specialist to review batch reports, confirm API material releases, and ensure compliance with cGMP and company SOPs on the shop floor. This role supports quality processes and minor change controls while collaborating with cross-functional teams to strengthen overall quality oversight.

You will participate in root-cause analyses, facilitate process confirmations, and serve as an authorized person per the Quality Manual, contributing to Novo Nordisk’s

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.
• 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

Skills

Batch review

Quality oversight

Communication skills

MS Office

Education

Bachelor's Degree in Life Sciences/Engineering

Tools

LIMS

SAP

NovoGlow

Job description

Novo Nordisk in Clayton, NC, is seeking a QA Specialist to review batch reports, confirm API material releases, and ensure compliance with cGMP and company SOPs on the shop floor. This role supports quality processes and minor change controls while collaborating with cross-functional teams to strengthen overall quality oversight.

You will participate in root-cause analyses, facilitate process confirmations, and serve as an authorized person per the Quality Manual, contributing to Novo Nordisk’s