Associate Quality Control Quality Microbiology, Cell Therapy
Core
Ensures safety, sterility, and compliance of raw materials, in-process samples, and final products through environmental monitoring, microbial testing, and aseptic processing support.
Role type
Associate Quality Control Microbiologist (Cell Therapy)
Builds
Clinical and commercial cell therapy products
Domain
Biotechnology / Cell Therapy / Pharmaceutical Manufacturing
Required skills
Environmental monitoring sampling, Media plate incubation and enumeration, Aseptic technique, Instrument operation and maintenance, cGMP compliance, Data recording (ALCOA+), Inventory management, Deviation documentation
Preferred skills
LIMS system experience, Prior QC/cGMP environment exposure, Microbiology degree
Technologies
LIMS (MODA, 1Lab), Electronic data systems
Responsibilities
Conduct non-viable and viable air sampling and surface viable sampling in GMP suites; Incubate and enumerate media plates; Operate lab instruments per SOPs; Assist in routine testing (Sterility, Mycoplasma, Bioburden, Endotoxin); Maintain lab inventory and housekeeping; Document deviations and support investigations
Seniority
Associate, entry-level IC