Environmental Monitoring Associate, Qc

Environmental Monitoring Associate, QC Overview

• The Environmental Monitoring Associate, QC, performs critical environmental and utility monitoring within GMP cleanroom suites.
• Collect and analyze environmental monitoring samples, including Water for Injection, clean steam, and compressed gases.
• Document results in Laboratory Information Management Systems (LIMS) following Good Documentation Practices (GDP).
• Prepare samples for microbial identification and transport while adhering to GMP standards.
• Support manufacturing operations by performing environmental monitoring during production activities.
• Assist in troubleshooting technical issues and maintaining environmental monitoring equipment.
• Contribute to laboratory meetings and collaborate with cross-functional teams for operational support.
• Ensure compliance with safety protocols and maintain a clean and organized laboratory environment.
• Participate in training programs to stay updated on procedures and techniques.

Environmental Monitoring Associate, QC Key Responsibilities & Duties

• Perform environmental monitoring tasks for aseptic environments and controlled areas as per SOPs.
• Incubate and enumerate microbial growth on environmental monitoring plates.
• Document tasks within LIMS or paper documentation using GDP principles.
• Collaborate with operations, manufacturing, and facilities teams for GMP process support.
• Participate in laboratory meetings and contribute to task management tools.
• Perform general laboratory tasks, including cleaning and equipment preparation.
• Maintain training compliance for all required tasks and procedures.
• Assist in limited-scope laboratory investigations as needed.
• Adhere to physical demand requirements, including lifting and working in controlled environments.

Environmental Monitoring Associate, QC Job Requirements

• High School Diploma/GED with 4+ years of experience or equivalent education and experience.
• Proficiency in oral, written, and interpersonal communication skills.
• Basic math skills and computer proficiency, including data entry.
• Ability to organize time independently and multitask effectively in a team-oriented environment.
• Capability to work in cleanroom environments requiring personal protective equipment (PPE).
• Physical ability to stand, stoop, bend, kneel, and lift up to 50 lbs.
• Experience with GMP documentation and laboratory practices preferred.
• Flexibility to support critical manufacturing operations during active production.
• Knowledge of microbial enumeration and environmental monitoring techniques.