Own and lead quality records (Deviations, CAPAs, Change Controls, Risk Assessments, Investigations) for cell manufacturing.
Triage issues on the manufacturing floor in real-time and lead root cause analysis.
Manage and close records in eQMS, ensuring compliance with GMP standards.
Collaborate with SMEs to define containment actions, root causes, and CAPAs.
Drive compliance initiatives and track CGT program execution within MTO.
Requires flexible schedule to support clinical manufacturing timelines.
- Dental insurance
- Health insurance
- Schedule: 2nd shift, Wed–Sat, 12 PM – 11 PM
- Quality control: 6 years (Required)
- Deviation: 6 years (Required)
- OOS Investigation: 6 years (Required)
- CAPA: 3 years (Required)