Job Title: QC Microbiologist
Location: TPP Tech – San Diego, CA
Department: Quality Control / Microbiology
Position Summary
TPP Tech is seeking an experienced QC Microbiologist to play a key role in maintaining the microbiological integrity of our pharmaceutical manufacturing operations for our CDMO. This individual will lead and perform advanced microbiological testing, oversee environmental monitoring programs, and support investigations within a 503B cGMP-regulated environment. The role requires deep knowledge of microbial testing standards and regulatory compliance.
Key Responsibilities
• Independently conduct and review microbiological testing of raw materials, in-process samples, finished products, and cleanroom utilities (bioburden, endotoxin, sterility).
• Oversee and perform routine environmental monitoring of classified spaces (air, surfaces, personnel), and trend EM data.
• Lead growth promotion, media qualification, and method suitability studies.
• Participate in and support microbial identification using classical and rapid methods.
• Act as a technical SME for microbiological deviations, out-of-specification results, and CAPA investigations.
• Draft and revise SOPs, protocols, and validation documentation for microbiological methods and cleanroom monitoring programs.
• Collaborate with cross-functional teams on cleaning validations, contamination control strategies, and facility qualification efforts.
• Support regulatory inspections and provide data or documentation as needed.
Qualifications
• B.S. in Microbiology, Biology, or a related scientific field.
• 5+ years of hands-on QC Microbiology experience in a cGMP pharmaceutical or 503B outsourcing facility.
• Deep knowledge of USP <61> , <62> , <71> , <85> , <1116> and related microbiological testing.
• Demonstrated expertise in aseptic technique, sterility testing (direct inoculation or isolator), and endotoxin assays.
• Experienced in interpreting microbiological data and implementing risk-based decisions for contamination control.
Preferred Attributes
• Strong understanding of cleanroom behavior, environmental monitoring trends, and excursion investigations.
• Familiarity with FDA/EMA regulatory expectations and audit preparation.
• Proactive problem-solver with excellent attention to detail and ability to mentor junior team members.
• Skilled in writing and reviewing microbiology-related protocols, reports, and SOPs.
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