QC Environmental Monitoring Analyst I

PCI Pharma Services•Bedford, NH

2d•Onsite

About The Position

The QC Environmental Monitoring Analyst I performs environmental monitoring and utility sampling and testing in support of Quality Control operations. The analyst monitors classified clean rooms during manufacturing, performs and documents plate reads and sample analyses, and executes protocols, experiments, and SOPs with some supervision. The role also includes reviewing peer work and SOP changes, assisting senior staff with investigations and complex protocols, inspecting media fill vials and plates, and maintaining the laboratory. Other duties may be assigned. This position is based in Bedford, New Hampshire, and reports to the QC Supervisor. It has a 12-hour rotating shift and requires the ability to work varied hours according to the production schedule. The analyst must be able to gown for work in ISO-8 through ISO-5 environments and handle hazardous materials.

Requirements

High school diploma, GED, or equivalent credential.
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.
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 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 meet the stated physical demands, including prolonged sitting or standing, walking and driving between locations, wearing laboratory protective gowning and equipment, and occasionally lifting or moving up to 50 pounds.
Must pass an eye exam.
Comfort 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; maintain gown qualification.
Analyze samples from Water for Injection, USP Purified Water, and Clean Steam systems, and perform and document plate reads for environmental and utility testing with some supervision.
Execute protocols, experiments, and SOPs under some supervision.
Review peer work and SOP document changes under some supervision.
Assist senior staff with preparing investigations and reports and executing complex protocols, as needed.
Conduct visual inspection of media fill vials and plates.
Perform general laboratory maintenance and housekeeping.
Perform other duties as assigned.