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American Regent, Inc. · 1 day ago

QC Microbiology Supervisor

Columbus, OH

Full-time

Onsite

Senior Level

5+ years exp

American Regent, Inc. is seeking a QC Microbiology Supervisor to oversee the Microbiology laboratory and ensure compliance with company policies and cGMPs. The role involves supervising a team, managing microbiological testing, and maintaining accurate documentation to support sterile pharmaceuticals.

Health CareMedical

H1B Sponsor Likely

Responsibilities

Ensure all work is performed and documented in accordance with existing company policies, procedures, and Current Good Manufacturing Practices, health, and safety requirements

Under the direction of the Microbiology Manager, supervise the Microbiology support testing team functions, Microbiologists, and technicians

Provide technical and administrative support for all activities related to Microbiological testing and documentation

Coordinates/conduct projects and special studies with the Microbiology Manager to meet department/site requirements

Schedule employees with respect to workload to improve efficiency. Conduct laboratory testing for customer complaints and internal investigations

Ensure all microbiological documentation is complete, neat, accurate and completed in timely manner

Issue and perform investigations, deviations, or event reports, CAPAs and ensure the closure in a timely manner

Train, provide technical assistance and guidance to microbiologists and technicians

Reviews, revise and prepares SOP’s and/or Protocols as necessary, recommend changes, update, and initiate change controls

Ensure tracking of support testing and release the results in timely manner

Review environmental monitoring tracking and trending of data in timely manner and present report to Microbiology Manager

Perform GAP Assessment on Microbiology procedures and keep them in compliance

Ensure and maintain the inventory required for the Microbiology laboratory and order supplies

Ensure that the laboratory is clean and sanitized

Assist Manager with timely completion of quarterly and other periodic projects and reports

Perform any other tasks/duties as assigned by management

Qualification

CGMP complianceMicrobiological testingSupervisory experienceAnalytical InstrumentsWater testingMicrobial Limit TestingTrackwise experienceMicrosoft Office proficiencyCommunicationAttention to detailTeam collaborationAdaptabilitySense of ownership

Required

Bachelor's degree in microbiology, Biology, or equivalent Life Science curriculum required

Minimum of 5 years of experience working in a cGMP compliant pharmaceutical Microbiology Laboratory

Minimum 2 years of supervisory or lead experience required

Experience with Water testing, Sterility suitability & testing of the finished products and Raw Materials, Bacterial Endotoxin Suitability & testing, Container Closure Testing, filter integrity testing, Microbial Limit Testing and Microbial Enumeration testing

Experience with Analytical Instruments such as Vitek, Balances, pH Meter, autoclave, BET, Sterility Isolators, Active Air Samplers, Particle Counters, LIMS, BSC, Incubators, etc

Experience with Trackwise for Deviations, CAPAs and Veeva CR process

Ability to lead a microbiology group towards department target goals

Experience with Microbiologist I, Microbiologist II, Microbiologist III and Microbiologist Lead duties and responsibilities

Demonstrate responsibility and accountability working within in a multi-disciplinary team environment ability to mentor subordinates

Organized individual with strong attention to detail

Excellent computer skills and proficient in Microsoft office software

Excellent communications skills both verbal and written

Needs to be adaptable and maintain the ability to be flexible in an ever changing and challenging environment

Sense of ownership and ability to take responsibility

Ability to work overtime, weekends and holidays as needed

Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves

Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision

Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly

Employee must be able to occasionally lift and/or move up to 25 pounds

Company

American Regent, Inc.

American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.

Founded in 1967

Shirley, New York, USA

501-1000 employees

http://www.americanregent.com/

H1B Sponsorship

American Regent, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (6)

2024 (10)

2023 (4)

2022 (5)

2021 (8)

2020 (9)