Quality Investigator - Cell Therapy Manufacturing

BioPharma Consulting JAD Group•Boston, MA
•Onsite

About The Position

The Quality Investigator will support cell therapy manufacturing quality in Boston, Massachusetts. The role investigates manufacturing and QC deviations, identifies root causes, and drives corrective and preventive actions (CAPAs) to closure. This is a 12-month contract with a possible extension. The position is on-site, and the shift will be set by the hiring manager and may be non-standard. The start is immediate.

Requirements

  • Bachelor’s degree in Engineering or a related field.
  • 2–5 years of experience.
  • Experience in pharmaceutical or biotechnology quality, manufacturing, or engineering.
  • Deviation and CAPA experience, including experience with an eQMS.
  • Clear technical writing.

Responsibilities

  • Investigate standard-complexity deviations using interviews, GEMBA, and root cause analysis tools.
  • Propose CAPAs in collaboration with subject matter experts and manage records in the electronic quality management system (eQMS), meeting due dates.
  • Support change controls and effectiveness checks.
  • Track deliverables and escalate risks to the team lead.
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