QC Environmental Monitoring Analyst III Lead

PCI Pharma Services•Bedford, NH

17h•Onsite

About The Position

PCI Pharma Services is hiring a QC Environmental Monitoring Analyst III Lead in Bedford, New Hampshire, in the Quality Control department. The role reports to the QC Supervisor and works a 12-hour rotating shift. The position performs environmental and utility monitoring and analysis, supports clean-room manufacturing operations, prepares and reviews controlled documentation, and helps coordinate work and train staff. The role requires gown qualification and the ability to work in ISO-8 through ISO-5 environments.

Requirements

High school diploma, GED, or equivalent credential.
7–9 years of experience in a cGMP environment; an equivalent combination of education and experience may 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 and work in ISO-8 through ISO-5 environments.
Ability to follow written instructions and independently troubleshoot common issues.
Ability to work in a complex environment with competing demands and priorities.
Ability to 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 and analysis of Water for Injection, RO/DI, USP Purified Water, and Clean Steam systems.
Monitor classified clean rooms during manufacturing operations while gown-qualified.
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.