QC Environmental Monitoring Analyst II
About The Position
The QC Environmental Monitoring Analyst II performs routine environmental monitoring in classified clean rooms and samples and analyzes water and clean steam utility systems. The analyst monitors clean rooms during manufacturing operations and must be qualified to gown for work in ISO-8 through ISO-5 environments. The role executes protocols, experiments, and SOPs with minimal supervision; reviews peer work and SOP changes; and supports senior staff with investigations, reports, and complex protocols. Additional work includes contributing to SOP creation and updates, visually inspecting media fill vials and plates, training staff in routine processes, and maintaining general laboratory housekeeping. The position is in the Quality Control department in Bedford, New Hampshire, reports to the QC Supervisor, and is listed as a 12-hour rotating shift.
Requirements
- High school diploma, GED, or equivalent credential.
- 5–7 years of experience in a cGMP environment; an equivalent combination of education and experience will be considered.
- Highly detail-oriented.
- Adaptable to changing priorities and deadlines.
- Exceptional organizational skills.
- Professional verbal communication skills.
- Excellent computer skills and ability to learn new software.
- Ability to work varied hours as required by the production schedule.
- Working or theoretical knowledge of laboratory equipment.
- Ability to identify and execute process improvements.
- Ability to gown to work in ISO-8 through ISO-5 environments.
- Ability to follow written instructions and independently troubleshoot common issues.
- Ability to work in a highly complex environment with competing demands and priorities.
- Ability to sit or stand for prolonged periods, walk and drive between locations, and occasionally lift or move up to 50 pounds.
- Ability to wear laboratory protective gowning and equipment, including goggles, face shields, and protective gloves.
- Must pass an eye exam.
- Comfort with working with or handling hazardous materials.
Nice To Haves
- Associate or bachelor's degree in Microbiology or a related scientific field.
Responsibilities
- Perform routine environmental monitoring of classified clean rooms.
- Perform routine utility sampling and analysis of Water for Injection, RO/DI, USP Purified Water, and Clean Steam systems.
- Monitor classified clean rooms during manufacturing operations while gown-qualified.
- Perform routine monitoring and analysis of the Clean Compressed Air System.
- Execute protocols, experiments, and SOPs under minimal supervision.
- Review peers’ work and SOP document changes under minimal supervision.
- Assist senior staff with preparing investigations and reports and executing complex protocols.
- Assist in authoring and collaborating on SOP creation and updates.
- Conduct visual inspection of media fill vials and plates.
- Train staff in routine processes.
- Perform general laboratory maintenance and housekeeping.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
