Microbiologist , EM

JOB SUMMARY

The Environmental Monitoring Microbiologist conducts cleanroom monitoring activities to ensure the air, surfaces, and critical utilities utilized for pharmaceutical product manufacturing meet cGMP requirements. These samples are collected according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures.

• Collects Environmental Monitoring Samples at client manufacturing sites on a daily basis in the greater Boston area.
• Sample collection types include: air viable, surface viable, water and compressed gas samples. Samples are then subsequently submitted to the lab for analysis.
• Understands the importance of aseptic technique and the critical role it plays in EM sample collection.
• Documents work in a clear and organized manner.
• Follows all safety rules and regulations and conducts periodic safety audits.
• Follows all cGMP rules and regulations.
• Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts.
• Performs routine data generation and problem solving with a minimal rework.
• Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.
• Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.
• Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.

Wednesday - Saturday 1st Shift

Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidances is preferred.