QC Microbiologist I Sun to Wed 3:30 PM to 2AM

About the role

Conducts sampling of product environments and/or facility clean utilities as per approved procedures. Tests collected samples for TOC/Conductivity, Bioburden, and Endotoxin. Performs quality control testing of in-process pharmaceutical products and other laboratory testing as assigned.

Responsibilities

• Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines; identifies safety risks and alerts management.
• Completes routine environmental monitoring of classified aseptic and non-aseptic areas within manufacturing facilities, including viable and non-viable particulates and contact plates, across multiple local production sites.
• Performs environmental monitoring of clean rooms and operations personnel during manufacturing as per approved procedures.
• Conducts utility sampling (purified water systems, water for injection systems, compressed air, clean steam) across multiple local production sites.
• Performs coliform, bioburden, endotoxin, TOC, conductivity, and appearance testing for utility and pharmaceutical product samples.
• Handles lab maintenance tasks: cleaning bench spaces and biological safety cabinets, stocking supplies, and general organization.
• Completes daily and weekly tasks in the Microbiology Laboratory, including product bioburdens, biological indicator testing, plate incubation, and enumeration.
• Performs growth promotion for media and growth verification for prepared microorganism cultures.
• Prepares microbial growth for shipment and identification as required.
• Adheres to verbal instructions and written procedures; accurately completes production documentation in compliance with GDP guidelines.
• Records data and assay performance with high attention to detail in paper or electronic systems.
• Completes data verification checks and inputs trended data.
• Reports events in the quality tracking system.
• Reviews documentation for tasks performed by the QC department for accuracy and traceability.
• Trains team members with less experience.
• Other duties as assigned.

Special Demands

• Frequent movement between different buildings for various tasks and responsibilities.
• Requires aseptic gowning and meticulous compliance with gowning procedures during clean room operations.
• Mid-level position within the QC Microbiology group; training less experienced team members is encouraged.

Physical Requirements

• Ability to wear personal protective equipment (safety glasses/goggles, gloves, safety shoes).
• Ability to gown and gain entry to controlled manufacturing areas.
• Ability to lift, pull, or push equipment requiring up to 15-20 lbs of force.
• Ability to stand for 6 hours in a production suite.
• Ability to work any shift (up to 10 hours) as required by business needs.

Work Environment

• Fast-paced environment with competing demands and priorities.
• Travel between multiple locations within Bedford and Manchester, New Hampshire.
• Resilient through operational change.
• Highly complex environment with varied hours as required by production schedules.
• Collaborative work environment.

Qualifications

• Exceptional organizational skills.
• Ability to follow written instructions and attention to detail.
• Ability to multi-task.
• Proficiency in word processing, Excel spreadsheets, and MS Office.
• Professional verbal and written communication skills.
• High school diploma with 1-2 years of experience in QC Microbiology or Environmental Monitoring, or a Bachelor’s degree in biology with 0-1 year of experience.