QC Environmental Monitoring Analyst III Lead
About The Position
The QC Environmental Monitoring Analyst III Lead performs routine environmental monitoring of classified clean rooms and routine utility sampling and analysis for Water for Injection, RO/DI, USP Purified 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 position also writes and executes protocols, experiments, and notebook studies; authors and updates SOPs; reviews peer work and paper and electronic records; and prepares investigations and reports while executing complex protocols. Additional duties include visually inspecting media fill vials and plates, assisting with work scheduling and support coverage, maintaining the laboratory, training staff in routine and advanced processes, and contributing to cross-functional meetings. The role reports to the QC Supervisor and works 12-hour rotating shifts on a 2-2-3 schedule during AM hours, with varied hours as required by the production schedule.
Requirements
- High school diploma, GED, or equivalent credential required.
- 7–9 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 complex environment with competing demands and priorities.
- Ability to stand, walk, sit, use hands to handle objects, tools, or controls, reach, balance, talk, and hear; sit or stand for prolonged periods; walk and drive between locations; wear laboratory protective gowning and equipment; occasionally lift or move up to 50 pounds; pass an eye exam; and work with 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; maintain gown qualification.
- Perform routine monitoring and analysis of the Clean Compressed Air System.
- Write and execute protocols, experiments, and notebook studies.
- Author and collaborate on SOP creation and updates.
- Review peers’ work for GDP and ALCOA+ compliance.
- Review paper and electronic records.
- Prepare investigations and reports and execute complex protocols.
- Conduct visual inspection of media fill vials and plates.
- Assist with scheduling routine work and support coverage.
- Perform general laboratory maintenance and housekeeping.
- Train staff in routine and advanced processes.
- Attend and contribute to cross-functional meetings as needed.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
