Associate II, Shop Floor Quality Assurance Cell Therapy
Core
Provide 24x7 quality oversight and compliance monitoring on the shop floor for cell therapy manufacturing, QC, and supply chain operations.
Role type
Associate II, Shop Floor Quality Assurance (Cell Therapy)
Builds
Cell therapy medicines for patients
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
cGMP compliance, aseptic technique monitoring, clean room gowning, operational verification, record review, discrepancy resolution, escalation, continuous improvement
Preferred skills
FDA/EMA regulations knowledge, biopharmaceutical or cell therapy manufacturing experience
Technologies
MS Office
Responsibilities
Provide on-the-floor quality oversight to Manufacturing/QC/Supply Chain; Perform operational verification per approved procedures; Observe operations for departures from clean room behaviors and aseptic techniques; Review manufacturing/testing records for compliance; Support internal and external inspections; Identify improvement opportunities.
Seniority
Associate, entry-level (0-2 years experience)