Description
The QC Senior Scientist – Microbiology is responsible for testing drug product and drug substance samples for release, in-process, and stability, as well as sampling, testing, and releasing raw materials for production use.
The Senior Scientist also performs data review and trend analysis, supports equipment management and lab duties, mentors and trains other analysts, supports product regulatory submissions and inspections, and coordinates laboratory activities for the team.
Responsibilities include:
- Conducting microbiological testing of laboratory samples
- Completing bioburden testing and bacterial endotoxin testing
- Carrying out routine and non-routine testing for quality disposition
- Executing growth promotion tests, media qualification, and biological indicators qualification
- Performing microbial identification
- Managing samples and associated documentation
- Authoring and executing protocol studies
- Participating in laboratory investigations and deviations
- Authoring, reviewing, and revising SOPs and controlled documents
- Reviewing and approving laboratory data
- Supporting analytical and instrument lifecycle activities
- Serving as a technical subject matter expert
Basic qualifications:
- Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related Life Science 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 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
Preferred qualifications:
- Experience with laboratory systems, including SAP/ERP, LES/LES-EM, LIMS, ELN, and analytical instrument software
- 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