Quality Investigator - Cell Therapy Manufacturing

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 60,000 - 90,000; Full time

Job summary

Biopharma-Consulting-Jad-Group invites a Quality Assurance professional to join our Boston team for a 12‑month, on‑site contract. You will investigate deviations, determine root causes and drive CAPAs to closure in a fast-paced cell therapy setting.

You will propose CAPAs with SMEs, manage eQMS records, support change controls and monitor effectiveness. Immediate start is expected, with shift details set by the hiring manager.

Qualifications

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

Responsibilities

• 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.

Skills

Root cause analysis

Gemba

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