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 and study-directed testing. The role reviews advanced test results, supports investigations, and serves as a qualified trainer and subject matter expert across multiple tests. It also supports laboratory management, audit readiness, regulatory inspections, and continuous improvement initiatives using LEAN and Six Sigma principles. The position is based in Bedford, New Hampshire, in the Quality Control department and reports to the QC Supervisor. The stated schedule is Sunday through Wednesday, 6:00 a.m. to 4:30 p.m. The role requires working with laboratory protective gowning and equipment and handling hazardous materials. It also requires the ability to work varied hours as production schedules require.

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.
Detail-oriented and able to multitask.
Ability to work varied hours as required by the production schedule.
Ability to follow written instructions and independently troubleshoot common issues, and provide expertise in responding to complex issues.
Ability to work in a highly complex environment with competing demands and priorities.
Ability to meet the physical demands of the role, 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 and be comfortable working with or handling hazardous materials.

Nice To Haves

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

Responsibilities

Performs non-routine, complex testing; identifies requirements and executes actions as part of the change control process.
Assists and guides others in the laboratory with routine testing.
Performs high-throughput, right-first-time work to meet production schedules and project milestones with minimal or no supervision.
Leads qualification and study-directed testing activities.
Reviews and evaluates advanced laboratory testing results.
Acts as a qualified trainer and subject matter expert for multiple tests.
Supports intermediate investigations of out-of-specification (OOS) assays and events.
Ensures compliance with cGMP and participates in audits and inspections.
Supports laboratory management and mentors other team members as needed.
Leads LEAN laboratory and Six Sigma principles and applies them to laboratory processes.
Leads audit readiness and participates in or supports the team during audits.
Performs other duties as assigned.