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Environmental Monitoring (EM) Specialist

Hims & Hers· QUALITY
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New Albany, OhioFull-timePosted 4d ago

About the role

Environmental Monitoring (EM) Specialist to perform routine environmental sampling and support contamination control within sterile pharmaceutical compounding cleanroom facilities, ensuring compliance with USP <797>, USP <800>, and 503A/503B standards. Overnight shift support.

Responsibilities

  • Perform routine non-viable and viable air sampling, surface sampling, and personnel monitoring sampling within ISO-classified cleanroom environments.
  • Ensure proper handling and labeling of sampling media to maintain integrity throughout the sampling and incubation process.
  • Accurately document sampling events, locations, results, and observations in compliance with internal SOPs and regulatory expectations.
  • Adhere to defined sampling schedules and respond to unscheduled or investigative sampling needs.
  • Manage the proper incubation of solid and liquid microbiological media at appropriate temperature conditions (e.g., 20–25°C and 30–35°C).
  • Perform interim and final readings of incubated media plates to identify and enumerate Colony Forming Units (CFUs).
  • Report and investigate results at alert and/or action levels.
  • Support the Microbiologist in responding to microbial growth events, including sample handling, documentation of excursions, and generation of preliminary reports.
  • Coordinate submission of microbial-positive samples to third-party laboratories and assist in investigation data gathering.
  • Maintain investigation logs and contribute to root cause analysis and corrective action activities.

Qualifications

  • Minimum 1 year of experience in one or more of the following: Non-viable particulate air sampling; Viable air sampling using impaction or settling plates; Surface sampling using contact plates or swabs; Personnel aseptic technique and gown sampling
  • Knowledge in gram staining and microbial growth identification
  • Ability to work in sterile garb for extended periods within an ISO Class 5 or cleaner environment
  • Successful completion or ability to pass initial and ongoing garbing and aseptic competency evaluations
  • Working knowledge of USP <795>, USP <797>, USP <800>, and sterile compounding requirements

Skills

Required:Non-viable particulate air samplingViable air samplingSurface samplingPersonnel aseptic technique

Benefits

  • Competitive salary & equity compensation for full-time roles
Last updated Oct 21, 2026. Interested? Apply on the company site.

About Hims & Hers

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