QA Associate Cryo
Core
Ensuring quality compliance and release of cryopreserved apheresis materials for CAR-T cell therapy manufacturing in a new state-of-the-art laboratory.
Role type
Quality Assurance Associate (Cryopreservation)
Builds
Cryopreserved patient starting material for clinical and commercial CAR-T products
Domain
Biopharmaceuticals / Cell Therapy / Oncology
Required skills
GMP/GTP environment experience, batch record review, deviation handling, audit preparation, document control, SOP management, KPI tracking
Preferred skills
Cell therapy and oncology knowledge, hospital or blood bank experience, documentation best practices
Technologies
Cryopreservation equipment, apheresis systems, LIMS (implied by batch records), GMP documentation systems
Responsibilities
Oversee daily QA operations for incoming fresh apheresis material; Review and release batch records for cryopreservation products; Manage document control for protocols, SOPs, and validation reports; Lead internal and external audit responses; Monitor and maintain key performance quality indicators; Handle deviations and implement corrective actions
Seniority
Entry to Mid-level, hands-on IC
