Description
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).
Responsibilities:
- 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.
Requirements:
- 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:
- 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.
Benefits:
- Comprehensive benefits program
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