QC Microbiologist II
On-site · Bridgeton, Missouri, United States
Job Summary
The role of QC Microbiologist II involves leading microbiological method development, transfer, and validation for biologics and small-molecule products, while performing routine and non-routine QC testing. Responsibilities include conducting microbiological and sanitization evaluations, authoring SOPs and technical documentation, and ensuring cGMP compliance. The position requires subject matter expertise in aseptic processing, environmental monitoring, and sterilization systems. A BS or MS in Microbiology and a minimum of 7 years of relevant experience in a GMP setting are mandatory, alongside strong skills in microbiological testing and regulatory compliance.
Required Qualifications
- BS or MS in Microbiology, Bacteriology, or a related biological science is required
- Minimum 7 years of microbiology experience in a GMP pharmaceutical, biotechnology, aseptic manufacturing, or CDMO setting
- Expertise in microbiological testing, including: Bioburden, sterility testing, endotoxin testing (LAL), microbial enumeration, growth promotion, microbial ID, container‐closure integrity, biological indicator qualification, and sanitization studies
- Deep knowledge of cGMP, FDA/ICH guidance, USP/EP microbiology chapters, sterility assurance expectations, and data integrity requirements
- Proficiency with standard microbiology instrumentation (incubators, isolators/RABS, particle counters, endotoxin readers, microscopes, etc.)
Desired Qualifications
- 3–5 years of experience in microbiological process control, aseptic operations, and cleanroom monitoring (viable and non‐viable particulates)
- Strong background supporting biologics (mAbs, proteins, peptides)
- Experience with sterilization systems (steam, dry heat, VHP), cleaning validation, and environmental data trending
- Experience supporting regulatory inspections as an SME is highly desirable
- Strong analytical problem‐solving skills with sound scientific judgment
- Excellent technical writing and verbal communication skills
- Demonstrated leadership, mentoring ability, and commitment to quality, compliance, and continuous improvement
Additional Requirements
- California residents should review our Notice for California Employees and Applicants before applying
- Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings
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