QC Senior Scientist

GSK•King of Prussia, PA

About The Position

The QC Senior Scientist – Microbiology tests drug product and drug substance samples for release, in-process, and stability purposes, and samples, tests, and releases raw materials for production use. The role also reviews data and performs trend analysis; supports equipment management and laboratory duties; mentors and trains analysts; supports regulatory submissions and inspections; and coordinates laboratory activities for the team. The position requires open availability, including some weekend work, and the ability to work independently while collaborating effectively across Quality, Manufacturing, and Technical Operations. The Senior Scientist conducts microbiological testing, manages samples and documentation, authors and executes protocols and controlled documents, supports investigations and troubleshooting, reviews laboratory data, and helps maintain GMP laboratory readiness. The role also supports analytical and instrument lifecycle activities, technical transfers, validation, and audits, and serves as a subject matter expert in laboratory techniques.

Requirements

Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related Life Science discipline and 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 3 years 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 collaborate effectively across Quality, Manufacturing, and Technical Operations.

Nice To Haves

Experience with laboratory systems, including SAP/ERP, LES/LES-EM, LIMS, ELN, and analytical instrument software such as WinKQCL and PyroTec PRO.
Proficiency in Microsoft Excel, Word, PowerPoint, and Veeva.
Working knowledge of cGXP, ICH guidelines, FDA requirements, 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 an F-M schedule.

Responsibilities

Conduct microbiological testing of laboratory samples, including raw materials, drug product, drug substance, in-process materials, and water.
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, and biological indicator qualification.
Perform microbial identification, including gram-stain and latex tests.
Manage samples and associated documentation throughout their lifecycle, ensuring compliance in 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 for accuracy, completeness, and regulatory compliance.
Perform routine departmental GMP activities and maintain laboratory readiness, including work orders, management monitoring inspections, 5S practices, DMAIC investigations, orange belt certification, change controls, and inventory management.
Support and lead analytical and instrument lifecycle activities, technical transfers, and validation processes.
Serve as a technical subject matter expert in multiple laboratory techniques and mentor junior team members.
Support internal and external audits as required.
Coordinate laboratory activities for the team and support product regulatory submissions and inspections.
Complete other duties as assigned.