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Environmental Monitoring Specialist

1 month ago

Albuquerque, New Mexico, United States curiate Full time
Job Summary

The Environmental Monitoring Analyst conducts microbiological tasks to aid production, such as monitoring cleanrooms for microorganisms and particles. They manage personnel sampling and certification in a cleanroom environment and perform non-routine sample collection for Standard Operating Procedures (SOPs) or investigations.

Key Responsibilities
  • Perform environmental monitoring of the cleanrooms (under USP and EU specifications) both viable and non-viable monitoring
  • Daily preparation of paperwork, supplies, and equipment for EM testing in a cleanroom setting
  • Perform microbial plating of personnel during manufacturing and personnel qualification
  • Collect data from the particulate monitoring system and audit system to ensure appropriate sensors are activated
  • Resolve environmental equipment malfunctions or errors
  • Perform non-routine or infrequent sampling (e.g., semi-annual static particulate monitoring, quarterly compressed air monitoring)
  • Perform current Good Manufacturing Practice (cGMP) documentation, and review sampling worksheets for documentation errors
  • Maintain current training status on equipment, procedures, and test methods
  • Read/interpret SOPs to ensure compliance
  • Maintain up to date trainings
  • Other duties as assigned
Requirements
  • High school diploma or general education degree (GED)
  • Minimum of two (2) years of experience in an Analyst position, preferred
  • Two (2) years related experience in production, manufacturing, and/or cleanroom, preferred
Preferred Skills
  • Skilled in Microsoft Word, Excel and Outlook
  • Ability to quickly adapt and learn new manufacturing software systems
Work Environment

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job.

The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required.

Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand.

The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration.

In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.