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QC Environmental Monitoring Analyst III Lead
PCI Pharma Services • Bedford, NH1d • Onsite
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QC Environmental Monitoring Analyst III Lead
PCI Pharma Services•Bedford, NH
•Onsite
About The Position
The QC Environmental Monitoring Analyst III Lead performs routine environmental monitoring of classified clean rooms and monitors these rooms during manufacturing operations. The role also conducts sampling and analysis of water and clean steam utility systems, as well as monitoring and analysis of clean compressed air. The analyst writes and executes protocols, experiments, and notebook studies; authors and collaborates on SOPs; reviews peers’ work for GDP and ALCOA+ compliance; and reviews paper and electronic records. The position handles investigations, reports, and complex protocol execution, conducts visual inspection of media fill vials and plates, and assists with scheduling routine work and support coverage. Additional duties include general laboratory maintenance, training staff in routine and advanced processes, and participating in cross-functional meetings as needed. This role is based in Bedford, New Hampshire, in the Quality Control department and reports to the QC Supervisor. The schedule is a 12-hour rotating 2,2,3 shift with AM hours. The position requires gown qualification and the ability to work in ISO-8 through ISO-5 environments, handle hazardous materials, follow written instructions, and troubleshoot common issues independently. The analyst must be comfortable working in a complex environment with competing demands and priorities.
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 the 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 an ISO-8 through ISO-5 environment.
- Ability to follow written instructions and independently troubleshoot common issues.
- Ability to work in a highly complex environment with competing demands and priorities.
- Physically capable of standing, walking, sitting, using hands to handle objects or controls, reaching, balancing, talking, and hearing.
- Ability to sit or stand for prolonged periods and walk or drive between locations.
- Ability to wear laboratory protective gowning and equipment, including goggles, face shields, and protective gloves.
- Ability to occasionally lift and/or move up to 50 pounds.
- Must pass an eye exam.
- Comfort working with and 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; 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
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Based on current job postings on Teal, the average Qc Analyst salary in the US is approximately $70,000 per year, with a typical range of $48,000 to $104,000.
