QC Microbiology Specialist I

PCI Pharma Services•Bedford, NH

1d•Onsite

About The Position

The QC Microbiology Specialist I performs complex and non-routine laboratory testing in a cGMP environment, supports production schedules and project milestones, and contributes to qualification, study, investigation, and audit-readiness activities. The role also guides and trains laboratory team members, serves as a subject matter expert for multiple tests, evaluates advanced testing results, and supports laboratory management. The position is based in Bedford, New Hampshire, and reports to the QC Supervisor. The schedule is Wednesday through Saturday, 6:00 a.m. to 4:30 p.m.

Requirements

High school diploma, GED, or equivalent credential.
5–7 years of experience in a cGMP environment; an equivalent combination of education and experience will be considered.

Nice To Haves

Associate or bachelor's degree in microbiology or a related scientific field.

Responsibilities

Perform non-routine complex testing, identify requirements, and execute actions as part of the change control process.
Assist and guide others in the laboratory with routine testing.
Perform high-throughput, right-first-time work to meet production schedules and project milestones with minimal or no supervision.
Lead qualification and study-directed testing activities.
Review and evaluate advanced laboratory testing results.
Serve as a qualified trainer and subject matter expert for multiple tests.
Support intermediate investigations of out-of-specification assays and events.
Ensure compliance with cGMP and participate in audits and inspections.
Support laboratory management and mentor team members as needed.
Lead LEAN laboratory and Six Sigma principles and apply them to laboratory processes.
Lead audit readiness and participate in or support audit activities for the team.
Perform other duties as assigned.