University of Missouri-Columbia · 4 hours ago
Quality Control Microbiologist I
The University of Missouri-Columbia is expanding its critical cancer-fighting and medical isotope production at the MURR facility. They are seeking a Quality Control Microbiologist I to support the microbiology group with responsibilities including environmental monitoring, sterility testing, and method development.
Education
Responsibilities
Training on and adherence to written procedures for cGMP (current good manufacturing practices – part of the FDA’s guidelines for production and quality control in the pharmaceutical industry) documentation, data review, equipment use and maintenance, cleanroom gowning and etiquette, cleanroom cleaning and disinfection, aseptic technique and aseptic gowning, radiation and laboratory safety, reports and investigations, and analytical testing
Environmental monitoring (measurement of viable and non-viable particles using dedicated equipment such as air samplers and particle counters, microbiological test media incubation, enumeration and characterization/identification of microbial isolates, documentation and review of test results to ensure compliance with established alert/action levels and limits for the associated ISO classification of the test area, data entry and statistical analysis of trends, investigation of adverse events/trends for root cause analysis and corrective and preventive action, summary report generation, submission of documentation for review and archival
Sterility, endotoxin, and bioburden testing of radiopharmaceutical APIs (active pharmaceutical ingredients)/products and components
Cleaning and disinfection of cleanrooms and related equipment on a routine basis using dedicated disinfectants and techniques per a written procedure
Inventory management (tracking expiration/calibration due dates, restocking materials/equipment, proper disposal of expired materials, etc.)
Performance of qualification procedures for equipment and test materials, including microbiological media
Routine review of and response to excursions for digital temperature and humidity datalogger data
Writing reports, investigations, instructions, and standard operating procedures
Training of colleagues on procedures performed by the QC microbiology group
Method development and validation testing as needed
Qualification
Required
Bachelor's degree or equivalent combination of education and experience from which comparable knowledge and skills can be acquired is necessary
Training on and adherence to written procedures for cGMP (current good manufacturing practices – part of the FDA's guidelines for production and quality control in the pharmaceutical industry) documentation, data review, equipment use and maintenance, cleanroom gowning and etiquette, cleanroom cleaning and disinfection, aseptic technique and aseptic gowning, radiation and laboratory safety, reports and investigations, and analytical testing
Environmental monitoring (measurement of viable and non-viable particles using dedicated equipment such as air samplers and particle counters, microbiological test media incubation, enumeration and characterization/identification of microbial isolates, documentation and review of test results to ensure compliance with established alert/action levels and limits for the associated ISO classification of the test area, data entry and statistical analysis of trends, investigation of adverse events/trends for root cause analysis and corrective and preventive action, summary report generation, submission of documentation for review and archival)
Sterility, endotoxin, and bioburden testing of radiopharmaceutical APIs (active pharmaceutical ingredients)/products and components
Cleaning and disinfection of cleanrooms and related equipment on a routine basis using dedicated disinfectants and techniques per a written procedure
Inventory management (tracking expiration/calibration due dates, restocking materials/equipment, proper disposal of expired materials, etc.)
Performance of qualification procedures for equipment and test materials, including microbiological media
Routine review of and response to excursions for digital temperature and humidity datalogger data
Writing reports, investigations, instructions, and standard operating procedures
Training of colleagues on procedures performed by the QC microbiology group
Method development and validation testing as needed
Must be available for reliable and consistent onsite work during business hours and occasional evenings and weekends
Successful candidates will be fluent and effective communicators with exceptional organizational and time management skills
They must demonstrate the following durable skills: leadership, character, collaboration, communication, creativity, critical thinking, mindfulness, growth mindset, and fortitude
Additionally, confidentiality, integrity, and a commitment to university values in their actions
Preferred
At least 6 months with direct experience with current Good Manufacturing Practices and radioactive material handling or 2 years related experience in microbiology lab
Benefits
Medical, dental and vision plans
Retirement
Paid time off
Short- and long-term disability
Paid parental leave
Paid caregiver leave
Educational fee discounts for all four UM System campuses
Company
University of Missouri-Columbia
We are Mizzou! Our distinct mission, as Missouri's only state-supported member of the Association of American Universities, is to provide all Missourians the benefits of a world-class research university.
H1B Sponsorship
University of Missouri-Columbia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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2025 (257)
2024 (213)
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2020 (131)
Funding
Current Stage
Late StageLeadership Team
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