QC Environmental Monitoring Technician I (5pm-1:30am) jobs in United States
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American Regent, Inc. · 1 day ago

QC Environmental Monitoring Technician I (5pm-1:30am)

American Regent, Inc. is responsible for the manufacture of safe, effective, and sterile pharmaceuticals. The Environmental Monitoring Technician I position is primarily responsible for performing environmental monitoring activities including sample collection of water, air, and surfaces within the classified areas of the manufacturing facility.

Health CareMedical
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H1B Sponsor Likelynote

Responsibilities

Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements
Manage assigned daily workload to meet requirements and perform sampling as per the schedule
Must complete and maintain gowning qualifications for support areas as well as the Aseptic Processing Area to work in clean rooms
Perform environmental monitoring activities including sampling of air (Viable and Non-viable), compressed air and nitrogen, surface, and personnel inside the classified manufacturing areas
Conduct water sampling throughout facility
Complete incubation, transfer and final reading of samples if needed
Record results and report deviations as per specifications
Capture sampling life cycles in the LIMS software and assist with data entry for retrieval and trending from Labware LIMS
Maintain accurate records of work performed in Labware LIMS and Laboratory documentation systems according to Good Documentation Practices, Standard Operating Procedures (SOPs) and policies
Maintains compliance with all required SOPs and policies
Communicate any discrepancies or deviations to supervision/management upon discovery
Author or help data collection for assigned investigation report related to EM/PM events
Perform clean room behavior and area assessments as per procedures if needed
Review environmental and personnel monitoring sample results in Labware LIMS if needed
Input data/results into database and conduct trend analysis
Perform any other tasks/duties as assigned by management

Qualification

Aseptic techniqueEnvironmental monitoringLaboratory documentationMicrobiology experienceLIMS softwareBasic math skillsMS-Office knowledgeCommunication skillsTime-management skillsTeamworkAttention to detail

Required

High School Diploma or GED equivalent required
Must complete and maintain gowning qualifications for support areas as well as the Aseptic Processing Area to work in clean rooms
Ability to perform basic mathematical calculations
Ability to work independently and as a team with minimal supervision
Organization and attention to detail
Excellent communication skills (Oral and Written)
Working knowledge of MS-Office software and PC Skills Required
Good work ethic and highly motivated
Good time-management skills
Ability to work in a fast-paced environment
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals
Ability to work overtime, weekend and holidays as needed
Physically able to wear and aseptically don cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
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
Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites

Preferred

Associate degree in microbiology, biology or related scientific field preferred
One year experience in academic or industry work experience in laboratory setting or manufacturing with focus on microbiology preferred
Knowledge of aseptic technique preferred

Benefits

Healthcare
Life insurance
Profit sharing
Paid time off
Matching 401k
A wide range of other benefits

Company

American Regent, Inc.

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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.

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)

Funding

Current Stage
Late Stage

Leadership Team

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Paul Diolosa
President & CEO
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Joseph Boyle
VP Finance / CFO
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Company data provided by crunchbase