Associate Quality Control Quality Microbiology, Cell Therapy

AstraZeneca•Rockville, MD

1d•Onsite

About The Position

This role supports safety, sterility, and compliance for raw materials, in-process samples, and final products through environmental monitoring, microbial testing, and aseptic processing support. The position performs routine activities with a focus on quality and data integrity, assists with laboratory maintenance and inventory, and supports QC operations to meet timelines. It contributes to regulatory compliance and product quality for clinical and commercial manufacturing. The position is on-site in a laboratory-based role and may involve cleanroom space. The schedule is four 10-hour days, Sunday through Wednesday. Annual base pay ranges from $55,920.80 to $83,881.20. The role is eligible for applicable incentives, including short-term incentive bonuses and equity-based awards for salaried roles. Benefits include qualified retirement programs, paid time off (vacation, holiday, and leaves), and health, dental, and vision coverage under applicable plan terms.

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.

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 laboratory 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 such as 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.