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Microbiology Lab Supervisor
4 months ago
Roles & Responsibilities:
- Build and manage a Microbiology lab within a cGMP-compliant analytical laboratory.
- Oversee lab workflow, personnel, and deliverables.
- Ensure compliance with relevant guidelines for OTC drugs, dietary supplements, cosmetics, and Rx Pharma products.
- Establish best practices for the Microbiology Lab.
- Develop and implement Standard Operating Procedures (SOPs), work processes, workflow, and reporting templates.
- Ensure protocols are consistent with bioburden, and other microbial testing standards.
- Manage validation of alternative microbiological methods.
- Oversee the transfer of validated methods to other facilities.
- Act as the Microbiology subject matter expert (SME).
- Write and review SOPs, and coordinate method development and validation for microbiological and analytical methods.
- Identify and engage best vendors for equipment, reagents, and disposables.
- Establish and maintain Microbiology Lab capabilities.
- Coordinate and support installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), as well as calibration and maintenance of lab equipment and instrumentation.
- Produce quality data across multiple microbiology methods and platforms.
- Perform daily quality control data reviews of results from the Microbiology Lab.
- Perform initial identification of microbial contaminants and isolates.
- Represent the Microbiology Lab in internal audits, client audits, and regulatory body inspections.
- Hire, train, and manage Microbiology Lab staff, including conducting annual reviews.
- Oversee daily lab operations, ensuring timely delivery of results and reports.
- Troubleshooting and Investigations:
- Lead troubleshooting for all Microbiology Lab issues.
- Conduct investigations for out of specification (OOS) results and manage deviations related to microbiology procedures.
Requirements:
- MS in Microbiology preferred, but Biology or other Life Sciences degrees acceptable.
- BS with significant experience will also be considered.
- MS with 3+ years of Microbiology Lab experience, including significant people and process management in an FDA cGMP-regulated environment.
- BS with 8+ years of experience, with at least 5 years managing people and developing methods in a Microbiology Lab within an FDA cGMP-regulated environment.
- Proficiency in maintaining and troubleshooting various microbiology lab methods, instruments, and equipment.
- Knowledgeable in bioburden, endotoxin testing, microbial identification, and industry environmental monitoring guidelines.
- Demonstrated ability as an independent worker, program builder, and problem solver.
- Capability to work effectively in high-stress, rapid growth environments.
- Strong people, communication, and leadership skills.
- Ability to prioritize tasks and adapt to changing environments.
