Qa Specialist Ii - Raw Materials

PCI Pharma Services

Bedford, NH, US
Bachelor's degree in scientific field
3 years gmp industry experience
Review of raw material documentation
The QA Specialist II provides critical oversight to Materials Management ensuring adherence to site SOPs and raw material specifications

Job Summary

  • The QA Specialist II provides critical oversight to Materials Management ensuring adherence to site SOPs and raw material specifications.
  • This role involves reviewing internal and external documentation for incoming raw materials and interpreting QC analytical testing results.
  • Candidates must possess a Bachelor's degree in a relevant scientific field with at least three years of GMP industry experience.

Matching Summary

The QA Specialist II provides critical oversight to Materials Management ensuring adherence to site SOPs and raw material specifications.

Skills & Requirements

Must-have

  • Bachelor's Degree in scientific field
  • 3 years GMP industry experience
  • Review of raw material documentation
  • FDA regulation knowledge 21CFR Part 210 211
  • USP and EP pharmacopoeia familiarity

Nice-to-have

  • Exceptional organizational skills
  • Excellent interpersonal communication
  • Proficiency in MS Office and Smartsheet
  • Ability to work in fast paced environment
  • Experience with international regulations EU ICH

Key Requirements

  • Bachelor's Degree in scientific field
  • Minimum 3 years GMP experience
  • Knowledge of FDA regulations 21CFR Part 210 211 & 820

Work Rights

Not specified

Tailored Resume

Cover Letter