QC Environmental Monitoring Analyst II
About The Position
The QC Environmental Monitoring Analyst II performs routine environmental monitoring in classified clean rooms and routine sampling and analysis of water, clean steam, and clean compressed air systems. The role monitors clean rooms during manufacturing operations and requires gown qualification for ISO-8 through ISO-5 environments. The analyst executes protocols, experiments, and SOPs with minimal supervision; reviews peers’ work and SOP changes; and supports senior staff with investigations, reports, and complex protocols. The position also contributes to authoring and updating SOPs, visually inspects media fill vials and plates, trains staff in routine processes, and maintains general laboratory housekeeping. Other duties may be assigned. This role works a 12-hour rotating 2-2-3 schedule on the AM shift and may require varied hours to meet production schedules. It involves working with hazardous materials, wearing laboratory protective gowning and equipment, and meeting the stated physical requirements, with reasonable accommodation where applicable.
Requirements
- High school diploma, GED, or equivalent credential required.
- 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 for work in ISO-8 through ISO-5 environments.
- Ability to follow written instructions and independently troubleshoot common issues.
- Ability to work in a complex environment with competing demands and priorities.
- Must pass an eye exam.
- Comfortable working with and handling hazardous materials.
- Physically able to wear laboratory protective gowning and equipment, including goggles, face shields, and protective gloves.
- Able to occasionally lift and/or move up to 50 pounds.
- Able to stand, walk, sit, use hands to handle objects or tools, reach, balance, talk, and hear; able to sit or stand for prolonged periods and walk and drive between locations.
Nice To Haves
- Associate or bachelor’s degree in microbiology or a related scientific field preferred.
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 in 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
