Microbiology Supervisor

Summary/objective The Microbiologist Supervisor is responsible for leading the microbiology laboratory in day-to-day activities, such as ensuring all raw materials, finished products, stability program samples, and research/validation batches are tested within company-mandated time periods. The Microbiology Supervisor may also serve as the stand-in Essential Functions approver when the Microbiology Manager is out of the office. The Microbiology Supervisor will delegate or, when necessary, complete the following task-related activities listed below: Adhere with SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulationsDirect training as the subject matter expert of all microbiologists and maintain training documentsUpdate the Associate Director of Quality Systems / Microbiology, QA and other plant management on microbiology testing and related activitiesEnsure the following microbiological testing related to the following microbiological test methods is either completed or performed by the microbiologists:Microbial Enumeration and Specified Microorganism (MET / SMT) testing per USP /Antimicrobial Effectiveness Testing (AET) per USP Preservative Effectiveness Testing (PET) per USP Purified/Source Water testing per USP Environmental Monitoring (EM)Water Activity Determination per USP Cleaning validation/verification microbiological recovery testingIsolate identification testing using the VITEK 2 Compact Isolate Identification SystemMicrobiological growth promotion and sterility verification testingInitiate, revise, or review the following Plant-controlled documents to ensure they are current and in compliance:SOPs, forms, and logbooks,SpecificationsChange ControlsMicrobiology Investigations / DeviationsInitiate and perform the following validation activities:Critical Systems Qualification of Equipment and/or Production Controlled RoomsTest Method ValidationPreservative Effectiveness StudiesApprove/review microbiology test records and logbooksMaintain and coordinate equipment/instrumentation maintenance, calibration, and repair workContact media and supply vendors to troubleshoot issuesSchedule and approve scheduled time off by microbiologistsSchedule and ensure the following microbiology activities are promptly and compliantly performed by the microbiologists: (This list is not designed to cover all activities, duties or responsibilities)Purified water system testing on required intervalsEnvironmental monitoring testing on required intervalsIsolate Identifications on Vitek ID SystemInitiate Isolate Identification Reports when necessaryUpdating, reviewing, and approving microbiological trendingApprove/review daily temperature readingsControlled substance complianceMedia and supply inventory maintenance, including ordering and releasing media, buffers, and microorganism culturesCleaning and sanitization activities in the microbiology laboratory Required Education And Experience Bachelor's degree in microbiology, biology, or related scientific field or equivalent experienceSeven (7) to ten (10) years of experience in a pharmaceutical microbiology laboratoryKnowledge of cGMP/GLP/GDP, USP / EU regulatory requirementsExperience performing microbiological testing / environmental monitoring using aseptic techniquesExcellent technical writing, project management, and organizational skillsExcellent interpersonal communication and organizational skillsQualified to work with controlled substancesKnowledge and experience performing serial dilutionsExperience Handling Biohazardous materialsKnowledge of USP, EU, and FDA requirements related to the positionExperience with regulatory audits position type/expected hours of work This is a full-time position on 1st shift and days/hours of work are Monday through Friday but extended (earlier or later) work times or weekend work may be required when the production needs exist or until the daily tasks or goals are met. physical demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is required to sit at a computer for long periods of time and occasionally required to stand for long periods of time collecting or processing samples. Specific vision abilities required by this position include close vision and color vision. work environment This job operates in a professional office environment and business casual attire with socks and closed toe shoes is required. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. This role requires good hygiene and hair / facial hair must be kept well-trimmed to prevent incidental contamination during testing. Working with Biohazardous materials is also prominent.