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 labs, and supply chain operations.
Role type
Associate II, Shop Floor Quality Assurance (Cell Therapy)
Builds
Cell therapy medicines for patients with serious diseases
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
physical/clinical work
Required skills
cGMP compliance, aseptic technique monitoring, operational verification, discrepancy resolution, record review, continuous improvement support
Preferred skills
FDA/EMA regulations knowledge, cell therapy manufacturing experience, STEM background
Technologies
MS Office
Responsibilities
Provide on-the-floor quality oversight to Manufacturing/QC/Supply Chain; Perform operational verification per approved procedures; Observe clean room behaviors and aseptic techniques; Review manufacturing/testing records for compliance; Support internal and external inspections; Identify and escalate quality issues.
Seniority
Associate, entry-level to early career