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Bachelor of Science;
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Senior Microbiologist Manager
Senior Microbiologist Manager to start a new Microbiology Laboratory with a national provider of specialty pharmacy. Opportunity to build a national program from the ground up that will support multiple facilities across the country producing aseptically-produced sterile compounds.
Manage and oversee a team of direct reports.
Assist with development of SOPs related to clean room controls and processes, assuring adherence to cGMPs, USP Standards, and company policies and procedures.
Develop and manage all Processes and Policy and Procedures relevant to microbiology department. Including but not limited to: Data management, LIMS implementation, Trending Results, Equipment Setup and Validation, ID technology procurement, etc.
Properly incubate and examine samples for microbial growth. Perform Gram stain as required and ID
Oversee data entry and trending of EM results into established data base. Create trending mechanism for all data and develop alert limits based upon historical data.
Perform routing laboratory duties which may include environmental monitoring which may include media growth promotion and handling, autoclave operation, testing equipment maintenance, cleaning of laminar flow hoods, proper disposal of samples, etc.
Assist with studies and investigations as needed. Complete additional sampling in response to investigative requirements.
Maintain effectiveness of the Quality System components relevant to this position.
Minimum 4 years of experience in cGMP Quality System function in the pharmaceutical or biotechnology industry.
Minimum 2 years supervisory/management experience.
Minimum one year experience working in Microsoft Office, specifically Excel, Outlook and Word.
Experience managing environmental programs.
Ability to deal appropriately with regulatory agencies.
Detailed knowledge of cGMP and USP and regulations and standards.
Bachelor’s degree in Microbiology.
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