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American Regent, Inc. · 1 day ago

QC Environmental Monitoring Supervisor

Hilliard, OH

Full-time

Onsite

Mid, Senior Level

2+ years exp

American Regent, Inc. is a company focused on the manufacture of sterile pharmaceuticals. The QC Environmental Monitoring Supervisor will oversee the environmental monitoring program, provide training to technicians, and ensure compliance with company policies and procedures.

Health CareMedical

H1B Sponsor Likely

Responsibilities

Under the direction of the Microbiology Manager, supervise the environmental monitoring program and technicians

Responsible for completing and maintaining gown qualification and gown training other staff members (Hilliard)

Provide technical and administrative support for all activities related to environmental monitoring, and documentation

Coordinates work projects with the Microbiology Manager to appropriately schedule EM workload to meet department/site requirements

Schedule employees with respect to workload to improve efficiency

As required assist EM technicians in sampling and other environmental monitoring responsibilities

Reviews SOP’s as necessary, recommend changes, update and initiate change controls as needed

Review EM paperwork accuracy and completeness and submit to laboratory with plates for incubation in timely fashion

Issue and perform internal investigations, deviations or event reports and ensure the closure of such reports for nonconforming results, in a timely manner

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

Ensure and check the media and material inventory required for the environmental monitoring program and order supplies as necessary

Closely interact with and support manufacturing and quality personnel in all aspects of environmental monitoring

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

Perform any other tasks/duties as assigned by management

Qualification

Environmental monitoringMicrobiologyAseptic processingSupervisory experienceEM protocolsData trackingTrendingComputer skillsCommunicationMentoringAdaptabilityTeamwork

Required

High School Diploma or GED equivalent required

2 -3 years experience in a pharmaceutical aseptic processing environment, production QA, aseptic testing, medical device or food industry in area of microbiology or a combination required

Previous experience working in environmental monitoring/sampling, writing EM protocols and EM investigations, water sampling, performing PQ of new EM and water systems, and gown qualification program required

Experience with instruments like Met One, APC, air ideal, MAS 100, MAS 100 CG, Lighthouse System, or PMS system is required

Must flexible with working hours dependable and able to work overtime as needed, according to the production schedule

Demonstrate responsibility and accountability working within in a multi-disciplinary team environment

Ability to mentor subordinates

Excellent computer skills and proficient in Microsoft Word, Excel, and Outlook

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 as needed

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

Specific vision requirements include 20/40 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

Preferred

Bachelor's Degree in microbiology, biology or Environmental Sciences or related scientific field preferred

Minimum 1-2 years of lead or supervisory experience preferred

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)