Seeking 1 Microbiology Supervisor
Onsite in Dupo, IL
The Microbiology Supervisor oversees the microbiological testing of samples submitted to the laboratory. Performs a dual role by working “hands-on” in the laboratory and responsible for more complex experimentation and training, while functioning as a supervisor in the laboratory. The primary functions are to oversee routine microbiological analyses, develop new methods for routine use, and ensure the facilities and processes adhere to GMP and ISO guidelines.
media fill failure
Manage overall Microbiology program and Microbiology lab personnel. The primary functions are to oversee routine microbiological analyses, develop new methods for routine use, and ensure the facilities and processes adhere to GMP and ISO guidelines.
Train and supervise the daily activities of the Microbiologists. Work closely with the Sr. Microbiologist to manage the training schedule matrix for the Microbiology lab.
Develop, implement, and continuously improve the systems, procedures and record-keeping necessary for the organized and efficient receipt of samples for microbiological testing.
Develop, validate, and continuously improve microbiological sample specifications and testing methodologies.
Oversee the assigned testing of samples submitted to the laboratory. Render dispositions in-specification or out-of-specification based on results.
Troubleshoot anomalous results generated by the microbiology laboratory. Perform testing in support of OOS investigations.
Develop and implement advanced microbiological laboratory instrumentation maintenance and calibrations programs.
Develop, implement, and control the systems, procedures, and record-keeping necessary for the organized and efficient reporting, peer-review, and archiving of laboratory testing & calibration data.
Guarantee the safe and correct use, sterilization and disposal of laboratory reagents, media, samples, etc., and maintain any state and Federal license necessary for the possession of testing and/or research chemicals.
Manage activities for Environmental Monitoring (viable and non-viable, compressed air, USP purified water) including sampling, monitoring, trending data, completing quarterly reports etc.
Serve as expert on bacteria, sterility, and micro contamination for investigations.
Microbiology Methods – write and perform periodic review.
Microbiology Method Verification and Validation protocols – write and execute protocols and reports.
Manage and perform release testing associated with micro.
Micro sampling and testing associated with Cleaning Verification/validation and hold time studies.
Manage Aseptic area activities (gowning qualifications, media fills, efficacy studies, PMT monitoring system)
Characterize local flora in production areas.
Identify, select, and procure equipment and/or technologies which will facilitate efficient micro work.
Maintain room and equipment for micro lab including managing or performing validation activities.
Write and/or review change controls, deviations and CAPAs.
write SOPs, Forms, reports as needed, additional duties as assigned
microbiology, environmental monitoring, GMP, aseptic processing, aseptic manufacturing, risk management, USP, PMT, quality assurance, supervisory skills, media fill failure, sterility, isolator technology
Additional Skills & Qualifications:
Knowledge of USP Methods
SME for inspections, audits, and validation
Particle Measurement Device (PMT)
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