Microbiology Supervisor
About the JobThe Microbiology Supervisor is responsible for overseeing the operations of the microbiology laboratory. Duties include managing direct reports, acting as Subject Matter Expert (SME) and contributing to audit-readiness. Perform routine testing and per review as needed. Key Responsibilities Management of lab staff direct reports including completion of performance feedback, reviews, disciplinary action and timecard administrationEnsure testing is initiated and performed in a timely manner and adhering to quality standardsAct as laboratory SMEDraft protocols and coordinate with laboratory manager to conduct investigations and special studies as neededDraft and edit SOPs as neededApprove CoAs as neededConduct and/or approve method suitability as neededAdhere to SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations.Perform microbiological testing and method validation related for the following microbiological test methods: Sterility Testing per USPEndotoxin per USPParticulate Matter per USP , ,Water for Pharmaceutical PurposeMicrobiological Examination of Nonsterile Products: Microbial Enumeration TestsOther tests as neededMicrobiological growth promotionAdhere to controlled substance requirementsReceive, and release media, buffers, and microorganism culturesUpdate and review microbiological trendingCompose, update, and review procedures and training materialsSanitize the laboratory incubators and refrigeratorsMaintain and coordinate equipment / instrumentation maintenance, calibration, and repair workClean and sanitize the microbiology laboratory rooms surfaces and equipmentManage personal time off by requesting the time off in company time keeping system for either PTO or VPTO according to company policy for salary employees as well as approving requests for direct reports. See company handbook for policy details.Other duties as assignedBasic QualificationsBachelor's degree in microbiology, biology, or related scientific field or equivalent experience, graduate degree is a plusPrior management experience preferredSix (6)+ years of experience in a pharmaceutical microbiology laboratory, combined laboratory and pharmaceutical quality experience will be considered (graduate degree may be considered as contribution to experience)Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirementsExperience performing microbiological testing / environmental monitoring using aseptic techniquesExcellent interpersonal communication and organizational skillsDemonstrated leadership skillsQualified to work with controlled substancesExperience Handling Biohazardous materialsAbility to interpret technical documentsProficiency in technical writing with an emphasis of deviations, CAPAs, etc.Project Management experience a plusMust be comfortable interacting within multiple areas of an organization and be able to communicate technical content in a concise and clear manner