Quality Investigator - Cell Therapy Manufacturing

BioPharma Consulting JAD Group

Boston (MA)

On-site

USD 90,000 - 120,000

Full time

3 days ago
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Job summary

BioPharma Consulting JAD Group in Boston, MA seeks a quality-focused professional to investigate deviations in cell therapy manufacturing and QC, drive CAPAs with SMEs, and manage records in the eQMS. The role supports change controls, effectiveness checks, and risk escalation.

The ideal candidate has 2–5 years in pharma/biotech quality or engineering, with strong technical writing skills and experience in CAPA processes. Start immediately on a 12-month, on-site contract.

Qualifications

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

Responsibilities

  • Investigate standard-complexity deviations using 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 elevate risks to the team lead.

Skills

Pharma/biotech quality, manufacturing,
Deviation/CAPA experience
Clear technical writing

Education

Bachelor's degree in Engineering or related

Tools

eQMS

Job 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 elevate risks to the team lead.
  • 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.
  • 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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