QC Scientist

GSK•King of Prussia, PA

About The Position

The QC Scientist – Microbiology performs and supports microbiological testing in a GMP-regulated pharmaceutical manufacturing environment. The laboratory-based position is approximately 80% hands-on testing and 20% laboratory support activities, with a primary focus on Bioburden and Bacterial Endotoxin Testing (BET). The role supports testing of raw materials, in-process materials, drug substance, drug products, utilities, and environmental monitoring samples. It requires open availability, including some weekend work, and the ability to work independently while collaborating across Quality, Manufacturing, and Technical Operations.

Requirements

Bachelor’s degree in microbiology, biology, biotechnology, or a related life science discipline and at least 3 years of hands-on microbiology laboratory experience; or an associate degree in a scientific discipline and at least 5 years of hands-on microbiology laboratory experience; or a master’s degree in microbiology, biology, or a related life science discipline and at least 1 year of hands-on microbiology experience in a GMP-regulated environment.
Experience working in a GMP/GxP-regulated pharmaceutical, biotechnology, medical device, or healthcare environment.
Experience performing Bioburden and Bacterial Endotoxin Testing (BET).
Open availability, including the ability to work some weekends.
Ability to work independently and effectively collaborate across Quality, Manufacturing, and Technical Operations.

Nice To Haves

At least 3 years of previous experience working in a GMP QC Microbiology Laboratory.
Advanced experience testing microbiological compendial methods in accordance with USP, EP, and JP requirements, ICH guidelines, and FDA expectations.
Experience with SAP or ERP, LES/LES-EM, LIMS, WebStatistica, Electronic Laboratory Notebook (ELN) systems, or Veeva.
Experience supporting investigations, CAPAs, deviations, and change controls.

Responsibilities

Perform routine and non-routine microbiological testing of raw materials, in-process samples, drug substance, drug product, and environmental and utility monitoring samples.
Execute Bioburden Testing and Bacterial Endotoxin Testing (BET) in accordance with approved procedures and compendial requirements.
Perform testing to support product release, stability studies, validation activities, and manufacturing operations.
Collect, test, review, and trend utility monitoring samples from pharmaceutical water systems, clean steam, and compressed gas systems.
Promptly escalate quality or compliance concerns to management.
Accurately document laboratory activities and results in compliance with cGMP, GDP, and ALCOA+ data integrity principles.
Identify opportunities for process improvements and laboratory efficiencies.
Perform routine laboratory housekeeping and inventory management activities.
Support method qualifications, method transfers, equipment qualifications, and validation activities as assigned.
Perform other duties as assigned.