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Quality Investigator - Cell Therapy Manufacturing

Job Description - Quality Investigator - Cell Therapy Manufacturing

Description

Grow your quality career in cell therapy at a leading biotechnology company in Boston, Massachusetts. You will investigate manufacturing and QC deviations, find root cause and drive CAPAs to closure.

What you'll do

  • Investigate standard-complexity deviations with interviews, GEMBA and root cause analysis tools.
  • Propose CAPAs with SMEs; manage records in eQMS and meet due dates.
  • Support change controls and effectiveness checks.
  • Track deliverables and escalate risks to the team lead.


Requirements
  • Bachelor's degree in Engineering or related + 2–5 years.
  • Pharma/biotech quality, manufacturing or engineering experience.
  • Deviation/CAPA experience and eQMS.
  • Clear technical writing.


Benefits
  • Contract: 12 months, with possible extension
  • Shift: On-site; shift set by the hiring manager (may be non-standard)
  • Start: Immediate
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