QC Environmental Monitoring Analyst I

PCI Pharma Services•Bedford, NH

About The Position

The QC Environmental Monitoring Analyst I performs routine environmental monitoring in classified clean rooms and utility sampling and analysis for water and clean steam systems. The role monitors clean rooms during manufacturing operations and requires gown qualification. The analyst documents testing and plate reads, executes protocols and SOPs with some supervision, reviews peer work and SOP changes, and may assist senior staff with investigations, reports, and complex protocols. Additional duties include inspecting media fill vials and plates and maintaining laboratory housekeeping.

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.
Strong 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 troubleshoot common issues independently.
Ability to work in a complex environment with competing demands and priorities.
Ability to work with hazardous materials.
Must pass an eye exam.
Physical ability to wear laboratory protective gowning and equipment.
Ability to stand, walk, sit, use hands to handle objects and controls, reach, balance, talk, and hear; sit or stand for prolonged periods; walk and drive between locations; and occasionally lift or move up to 50 pounds.

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 while gown-qualified.
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 as needed with investigations, reports, and execution of complex protocols.
Conduct visual inspection of media fill vials and plates.
Perform general laboratory maintenance and housekeeping.
Perform other duties as assigned.