Associate Quality Control Microbiologist - Cell Therapy

4h4 hours ago

AstraZeneca

Rockville, US · Full-time · $55,921 – $83,881

About this role

In this role, you will support routine microbiological quality control activities for cell therapy manufacturing at AstraZeneca's Rockville site. You will perform critical testing including Rapid Sterility, Mycoplasma, Bioburden, Endotoxin, Growth Promotion, and Cell Aliquoting under approved methods and cGMP/GDP expectations.

Your day-to-day work involves environmental monitoring in classified GMP spaces, including non-viable and viable air sampling and surface viable sampling in aseptic processing areas. You will also handle incubation and enumeration of media plates and samples, process plates for microbial identification through external laboratories, and operate laboratory instruments in accordance with SOPs.

This role operates on a Wednesday through Saturday shift with four 10-hour days each week, working on-site in a lab-based and cleanroom environment. You will document data accurately in electronic systems following ALCOA+ principles and support lab housekeeping, inventory management, sample logistics, and investigations.

You will contribute directly to product quality, patient safety, and regulatory compliance while growing your microbiology career in a dynamic, evolving environment. This position offers the opportunity to become gown certified for Grade D, C, and B environments and to expand your technical skills over time.

Requirements

Associate's degree in Biological Sciences, Biology, Microbiology, or a related discipline with 2 years of experience, or Bachelor's degree with 6 months of experience
Ability to work on-site in a lab-based and cleanroom environment
Understanding of core cGMP concepts, Good Documentation Practices, and laboratory compliance
Ability to follow SOPs precisely, maintain accurate records, and escalate discrepancies in a timely manner
Willingness and ability to become gown certified for Grade D, C, and B environments
Flexibility to support the Wednesday to Saturday shift across four 10-hour days

Responsibilities

Support routine microbiological quality control activities including Rapid Sterility, Mycoplasma, Bioburden, Endotoxin, Growth Promotion, and Cell Aliquoting under approved methods and cGMP/GDP expectations
Perform environmental monitoring in classified GMP spaces, including non-viable and viable air sampling and surface viable sampling in aseptic processing areas
Handle incubation and enumeration of media plates and samples, and process plates for microbial identification through external laboratories
Operate laboratory instruments in accordance with SOPs and document data accurately in electronic systems following ALCOA+ principles
Support lab housekeeping, inventory management, sample logistics, and investigations
Contribute to ongoing analyst training and qualification activities
Maintain gowning certification for Grade D, C, and B environments and adhere to cleanroom protocols

Benefits

Annual base pay range of $55,920.80 - $83,881.20
Eligibility for short-term incentive bonuses and equity-based awards
Qualified retirement programs
Paid time off including vacation, holiday, and leaves
Health, dental, and vision coverage in accordance with the terms of the applicable plans