Qa Specialist Ii

KBI Biopharma

Durham, NC, United States
Gmp compliance review
Analytical data review
Method qualifications approval
This position is responsible for the compliance review of Biopharmaceutical Development GMP data

Job Summary

  • This position is responsible for the compliance review of Biopharmaceutical Development GMP data.
  • Another responsibility is the review and approval of laboratory investigations and deviations associated with the biopharmaceutical development department.
  • KBI Biopharma is committed to providing a safe and healthy workplace.

Matching Summary

This position is responsible for the compliance review of Biopharmaceutical Development GMP data.

Skills & Requirements

Must-have

  • GMP compliance review
  • analytical data review
  • method qualifications approval

Nice-to-have

  • strong problem-solving skills
  • effective communication abilities
  • team-oriented environment

Key Requirements

  • BS with 11+ years experience
  • MS with 8+ years experience
  • knowledge of USP, EU, and JP cGMP guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter