QA Specialist III
Core
Ensuring quality and compliance in the development and manufacturing of personalized CAR T-cell cancer therapies.
Role type
Senior Quality Assurance Specialist (Regulated Industry)
Builds
Personalized cell therapies for cancer treatment
Domain
Biopharmaceuticals / Oncology / Cell Therapy
Required skills
GMP/GLPs, FDA/EMEA standards, Six Sigma, LEAN, root cause analysis, audit and investigation, report writing
Preferred skills
Deviation/OOS/CAPA oversight, process efficiency identification, in-process and final product issue resolution
Technologies
Microsoft Office
Responsibilities
Provide QA oversight and approval of deviation, OOS, change control, CAPA, and EV records; Ensure records are properly initiated, investigated, and resolved; Escalate deviations per procedures; Identify efficiencies in Deviation and CAPA processes; Provide QA support resolving manufacturing, environmental, facility, and equipment issues.