Job Summary
The QC Scientist – Microbiology is responsible for performing and supporting microbiological testing activities for raw materials, in-process materials, drug substance, drug products, utilities, and environmental monitoring samples in a GMP-regulated pharmaceutical manufacturing environment. This laboratory-based position consists of approximately 80% hands-on testing and 20% laboratory support activities, with a primary focus on Bioburden and Bacterial Endotoxin Testing (BET).
This position operates on a Friday–Monday weekend shift schedule and requires the ability to work independently while effectively collaborating across Quality, Manufacturing, and Technical Operations.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Perform routine and non-routine microbiological testing of: Raw materials, In-process samples, Drug substance, Drug product, EM/UM 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.
- Escalate quality or compliance concerns promptly 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.
- Performs other duties as assigned.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related Life Science discipline with 3+ years of hands-on microbiology laboratory experience
- OR Associate degree in a scientific discipline with 5+ years of hands-on microbiology laboratory experience
- OR Master’s degree in Microbiology, Biology, or a related Life Science discipline with a minimum of 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).
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- 3+ years of previous experience working in a GMP QC Microbiology Laboratory
- Advanced experience with testing microbiological compendial methods in line with: USP, EP, and JP requirements, ICH guidelines and FDA expectations.
- SAP or ERP, LES/LES-EM, LIMS, WebStatistica, Electronic Laboratory Notebook (ELN) systems, Veeva.
- Experience supporting investigations, CAPAs, deviations, and change controls.
- Experience using laboratory and quality systems such as:
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