QC Supervisor - Microbiology

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

• Write and Implement Standard Operating Procedures according to cGMP and cGLP.

• Develop and validate new test methods for raw material, in-process, and finished product samples (Sterility, Bioburden and Indicator Organisms, Endotoxin, AET, etc. per USP and FDA guidance).
• Establish and implement Environmental Monitoring Program (air, compressed gases, water, surfaces, personnel) per USP, FDA, ISO, and PDA guidelines.
• Performance and documentation of laboratory investigations.
• Perform internal auditing and assistance in handling of external audits by customers and FDA during departmental review.
• Develop and maintain cryo-stored cell line including in house identified isolates
• Submit purchase orders for equipment and materials.
• Interview potential candidates and onboard new employees.
• Assist with autoclave and depyrogentaion oven validations.
• Generate staff shift and schedules aligned with required QC and manufacturing support functions.
• Establish, monitor and investigate Action and Alert limit excursions and implement corrective and preventive actions, as needed.
• Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
• Maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs daily.
• Perform training on laboratory methods and instrumentation.
• Perform other duties as assigned.

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Experience Requirements*

• Minimum of five years of experience in a QC Microbiology Laboratory.

• Must demonstrate proficiency in microbiology laboratory techniques such as water analysis by membrane filtration, endotoxin analysis, sterility analysis, and identification.
• Previous supervisor experience or demonstrated skills to lead/mentor a group cohesively and effectively.

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Education Requirements*

Bachelor’s degree in Microbiology or related scientific discipline.

Job Type: Full-time