QC Environmental Monitoring Analyst I

PCI Pharma Services•Bedford, NH

About The Position

The QC Environmental Monitoring Analyst I performs routine environmental monitoring of classified clean rooms and utility sampling of Water for Injection, RO/DI, USP Purified Water, and Clean Steam systems. The role monitors clean rooms during manufacturing operations and performs analysis and documented plate reads for environmental and utility testing with some supervision. The analyst executes protocols, experiments, and SOPs, reviews peer work and SOP changes, and may assist senior staff with investigations, reports, and complex protocols. Additional duties include visual inspection of media fill vials and plates, general laboratory maintenance and housekeeping, and other assigned work. The role is based in Bedford, New Hampshire, in Quality Control, and reports to the QC Supervisor. The schedule is a 12-hour rotating 2,2,3 shift with AM hours.

Requirements

High school diploma, GED, or equivalent credential required.
3–5 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, and exceptionally organized.
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 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.
Ability to stand, walk, sit, use hands to handle objects, tools, or controls, reach, balance, talk, and hear.
Ability to sit or stand for prolonged periods and walk and 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 and be comfortable 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 of Water for Injection, RO/DI, USP Purified Water, and Clean Steam systems.
Monitor classified clean rooms during manufacturing operations and maintain gown qualification.
Analyze samples from Water for Injection, USP Purified Water, and Clean Steam systems.
Perform and document plate reads for environmental and utility testing with some supervision.
Execute protocols, experiments, and SOPs under some supervision.
Review peers’ work and SOP document changes under some supervision.
Assist senior staff with investigations, reports, and complex protocols as needed.
Conduct visual inspection of media fill vials and plates.
Perform general laboratory maintenance and housekeeping.
Perform other duties as assigned.