Position Summary
The Supervisor, Microbiology will report the Director, Microbiology. The incumbent will be responsible for establishing testing timelines, executing the plan, and monitoring the results.
Job Responsibilities
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Assist with writing and implementing SOP’s, work instructions and protocols according to cGMP and cGLP.
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Performance and documentation of laboratory investigations.
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Perform internal auditing and assistance in handling of external audits by customers and FDA during departmental review.
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Develop and maintain cryo-stored cell line including in house identified isolates
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Submit purchase orders for equipment and materials.
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Interview potential candidates and onboard new employees.
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Assist with autoclave and depyrogentaion oven validations.
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Generate staff shift and schedules aligned with required QC and manufacturing support functions.
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Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
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Maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs daily.
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Perform training on laboratory methods and instrumentation.
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Complete Resource Conservation and Recovery Act training within 6 months of hire and annually thereafter.
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Perform other duties as assigned.
Experience Requirements
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Minimum of five years of experience in a QC Microbiology Laboratory.
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Must demonstrate proficiency in microbiology laboratory techniques such as water analysis by membrane filtration, endotoxin analysis, sterility analysis, and identification.
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Previous supervisor experience or demonstrated skills to lead/mentor a group cohesively and effectively.
Education Requirements Bachelor’s degree in Microbiology or related scientific discipline.