Qc Microbiologist I

PCI Pharma Services•Bedford, NH

About The Position

The QC Microbiologist conducts sampling and testing of production environments and/or facility clean utilities in accordance with approved procedures. The role performs laboratory work and other tasks assigned by management. It includes routine environmental monitoring of classified clean rooms, monitoring rooms during manufacturing operations, and sampling and testing water and clean steam systems. The position also supports protocol and SOP work, peer reviews, media fill inspections, laboratory upkeep, and staff training.

Requirements

3–5 years of experience in a cGMP environment.
Two years of experience may be replaced by an associate degree or a non-scientific bachelor's degree.
Four years of experience may be replaced by a BS/BA degree in Microbiology or a related scientific field.
Must be gown-qualified to monitor classified clean rooms during manufacturing operations.

Responsibilities

Perform routine environmental monitoring of classified clean rooms.
Monitor classified clean rooms during manufacturing operations and maintain gown qualification.
Sample and test Water for Injection systems, USP Purified Water systems, and Clean Steam systems.
Perform and document plate reads for environmental and utility testing with minimal supervision.
Write and execute protocols, experiments, and SOPs under limited supervision.
Review peers’ work and SOP document changes under limited supervision.
Assist senior staff with investigations, reports, and execution of complex protocols.
Visually inspect media fill vials and plates.
Perform general laboratory maintenance and housekeeping.
Train staff in routine processes.
Perform other duties as assigned.