QC Senior Scientist (Microbiology)

and requires the ability to work independently while effectively collaborating across Quality, Manufacturing, and Technical Operations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Conduct microbiological testing of laboratory samples (raw materials, drug product, drug substance, in-process materials, water, etc.)
• Complete bioburden testing and bacterial endotoxin testing (BET) in accordance with approved procedures and compendial requirements.
• Carry out routine and non-routine testing for quality disposition in support of manufacturing operations, technical transfers, and special studies within the product supply chain.
• Execute growth promotion tests, media qualification, biological Indicators qualification.
• Perform microbial identification, including gram-stain and latex tests.
• Manage samples and associated documentation throughout their lifecycle, ensuring compliance in both physical and electronic systems.
• Author and execute protocol studies, as applicable.
• Participate in and/or lead laboratory investigations, deviations, and assay troubleshooting with minimal supervision.
• Author, review, and revise SOPs, user requirement specifications (URS), and other controlled documents.
• Review and approve laboratory data to ensure accuracy, completeness, and compliance with regulatory standards.
• Perform routine departmental GMP activities and maintain laboratory readiness, including, work orders, management monitoring inspections, 5S practices, DMAIC investigations, orange belt certification, change controls, inventory management, etc.)
• Support and lead analytical and instrument lifecycle activities, technical transfers, and validation processes to maintain robust laboratory operations.
• Serve as a technical subject matter expert (SME) in multiple laboratory techniques, provide mentorship to junior team members, and support internal and external audits as required.
• Complete other duties as assigned.

Why you?

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 5+ years of hands-on microbiology laboratory experience

•

Master’s degree in Microbiology, Biology, or a related Life Science discipline with a minimum of 3 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).

If you have the following characteristics, it would be a plus:

• Experience with laboratory systems preferred, including: SAP/ERP, LES/LES-EM, LIMS, ELN, and analytical instrument software (WinKQCL, PyroTec PRO). Proficient in Microsoft Excel, Word, PowerPoint, and Veeva.

• Working knowledge of cGXP, ICH guidelines, FDA, USP/EP/JP compendial requirements, and data integrity principles.

• Ability to work independently and collaboratively in a team environment with minimal supervision.

• Excellent organizational and task management skills.

• Advanced understanding of microbiological methods and laboratory techniques.

• Working knowledge of automation platforms.

• Strong data analysis, trending, technical writing, and written and verbal communication skills.

• Effective problem solving and critical thinking skills.

• Ability to work weekends as part of a F-M schedule

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