Associate Quality Control Quality Microbiology, Cell Therapy
About The Position
This role ensures the safety, sterility, and compliance of raw materials, in-process samples, and final products through environmental monitoring, microbial testing, and aseptic processing support. It focuses on learning and performing routine activities with high quality and data integrity, assisting with laboratory maintenance and inventory, and supporting QC operations to meet timelines. The position supports regulatory compliance and product quality for clinical and commercial manufacturing. The role is based on-site in a laboratory and cleanroom environment and follows a schedule of four 10-hour days, Sunday through Wednesday.
Requirements
- Associate’s degree in biological sciences, biology, microbiology, or a related discipline with two years of experience, or a bachelor’s degree with at least three months of experience.
- Experience in a pharmaceutical/biotech or related academic setting.
- Understanding of core cGMP concepts, Good Documentation Practices, and laboratory compliance; ability to follow SOPs precisely and ask clarifying questions.
- Strong focus on right-first-time execution, accurate record-keeping, and timely escalation of discrepancies.
- Effective cross-functional collaboration, flexibility in an evolving environment, and a positive, solutions-oriented attitude.
- Enthusiasm for developing technical skills and expanding responsibilities with experience.
- Ability to work on-site in a laboratory-based role or within cleanroom space.
- Ability to support a schedule of four 10-hour days, Sunday through Wednesday.
Nice To Haves
- Exposure to QC, cGMP environments, or regulated documentation.
- Experience with a LIMS system such as MODA or 1Lab.
Responsibilities
- Complete environmental monitoring sampling in GMP suites, including non-viable and viable air sampling and surface viable sampling.
- Obtain gown certification for Grade D, C, and B environments to support environmental monitoring sampling.
- Incubate and enumerate media plates and samples.
- Process and send media plates to an outside testing laboratory for identification.
- Operate assigned instruments according to SOPs, including daily checks, calibrations, and routine maintenance.
- Assist with routine testing under supervision, such as rapid sterility, mycoplasma, bioburden, endotoxin, growth promotion, and cell aliquoting, following approved methods and cGMP/GDP expectations.
- Record data contemporaneously in relevant electronic systems and ensure completeness, accuracy, and compliance with ALCOA+ principles.
- Maintain consumables and reagent inventory; perform lab housekeeping, 5S, and equipment cleaning; and support sample logistics and courier/chain-of-custody processes.
- Assist with documenting deviations and events and provide data and observations for investigations, including OOS/OOT; follow implemented CAPAs and change controls.
- Communicate testing status, material needs, and issues to the team, and support scheduling and sample coordination to meet lot release timelines.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Commissions for sales roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
