Qa Specialist I - Ops

PCI Pharma Services

Bedford, New Hampshire, US
Gmp facility experience required
Batch record review skills needed
Real-time quality oversight duties
The role provides essential QA support for manufacturing and visual inspection activities within a global biopharma network

Job Summary

  • The role provides essential QA support for manufacturing and visual inspection activities within a global biopharma network.
  • Responsibilities include real-time monitoring of processes, batch record reviews, and acting as the first responder for on-floor quality issues.
  • Candidates will guide personnel on cGMP compliance while participating in root cause analysis and quality system initiatives.

Matching Summary

The role provides essential QA support for manufacturing and visual inspection activities within a global biopharma network.

Skills & Requirements

Must-have

  • GMP facility experience required
  • Batch record review skills needed
  • Real-time quality oversight duties
  • FDA regulations knowledge (21CFR Part 820)
  • Root cause analysis methodology exposure

Nice-to-have

  • Lean operation excellence background
  • ASQ certification preferred
  • Risk management tools familiarity
  • Strong organizational and detail skills
  • Ability to work in fast-paced environment

Key Requirements

  • Bachelor's Degree in scientific field preferred
  • Minimum 2 years GMP industry experience
  • Exposure to technical writing and investigations

Work Rights

Not specified

Tailored Resume

Cover Letter