Environmental Monitoring Sampling Analyst
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. ***Travel is required in this position. Opportunities available will require you to temporarily relocate (on the company expense) for up to 6 weeks or more at a time.***
PRIMARY DUTIES AND RESPONSIBILITIES:
- 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.
REQUIREMENTS & QUALIFICATIONS
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. DAILY TRAVEL REQUIRED DURING WORK DAY HOURS (BOSTON & SALEM, NH).
MINIMUM SKILLS REQUIREMENTS
- Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
- A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
- Must have excellent organizational, verbal communication and technical documentation skills.
- Solid computer skills.
- Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.