Environmental Monitoring Analyst I

Summary

The Environmental Monitoring (EM) 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.

Essential Duties and 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

Education and Experience

• 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

Computer Skills

• Skilled in Microsoft Word, Excel and Outlook
• Ability to quickly adapt and learn new manufacturing software systems

Other Skills and Abilities

• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
• Demonstrates strong attention to detail
• Strong writing skills

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• Must be able to obtain and maintain gowning certification
• Must be able to obtain and maintain media qualification
• Must be able to wear a respirator

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently
• Regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity
• Visual acuity, both close and distant, along with depth perception is necessary, with or without corrective lenses (employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents)
• Hand and finger dexterity are integral, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons
• Occasional stooping, kneeling, twisting, crouching, crawling and balancing
• Certain roles may involve climbing and working at elevated heights

Work Environment

The work environment characteristics described below are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• May be required to work in an office, manufacturing, or warehouse environment
• Office environment: designed for comfort and productivity, with room temperature settings maintained for optimal working conditions; conversational noise in the background is common
• Pharmaceutical manufacturing environment: sterile; 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
• May be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment
• Warehouse environment: typically set at a controlled temperature but 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
• 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