Supervisor, QC Microbiology M-F Second Shift

PCI Pharma Services • Bedford, NH

4d

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. As the QC Microbiology Supervisor, you will: Lead daily lab operations—including oversight of environmental monitoring, microbial testing of utilities (USP <61>, <62>, <85>), and in-process/final product testing Supervise, mentor, and develop a high-performing team of microbiologists and lab personnel Manage scheduling, workloads, and ensure timely testing and release of all microbiological samples Perform risk assessments and investigations (EM excursions, aseptic incidents) and implement effective CAPAs Perform data trending and statistical analysis; author quarterly reports on environmental and utility data Oversee testing for endotoxins, bioburden, growth promotion, EM sampling, and clean utility sampling Collaborate cross-functionally with Operations and Facilities to protect aseptic integrity Support and coordinate equipment validation, calibration, and maintenance Drive compliance with cGMP, FDA, EU, and international microbiology regulations Review and author SOPs, support method development, and guide test execution to regulatory expectations Who You Are You bring not only technical microbiology expertise but also strong leadership skills and a desire to coach, inspire, and elevate your team. You're a critical thinker with a strong quality mindset who enjoys solving complex problems and helping ensure patients receive safe, effective products.

Requirements

• Master’s degree in Microbiology, Biology, or related life science (preferred) OR Bachelor’s degree with 5+ years of progressive GMP QC Microbiology experience
• 1–3+ years in a leadership role within a QC Microbiology lab
• Hands-on experience with aseptic processing, environmental monitoring, and USP microbiological testing required
• Skilled in data analysis and report writing
• Must be able to work across NH PCI sites, including remote locations
• Ability to gown for ISO-classified cleanroom work
• Ability to lift up to 20 lbs
• Occasional off-shift support may be required

Nice To Haves

• In-depth understanding of ISO cleanroom classifications and GMP clean utility systems
• Strong knowledge of U.S. and international microbiology regulations
• Experience with media qualification, microbial identification, and root cause investigations

Responsibilities

• Lead daily lab operations—including oversight of environmental monitoring, microbial testing of utilities (USP <61>, <62>, <85>), and in-process/final product testing
• Supervise, mentor, and develop a high-performing team of microbiologists and lab personnel
• Manage scheduling, workloads, and ensure timely testing and release of all microbiological samples
• Perform risk assessments and investigations (EM excursions, aseptic incidents) and implement effective CAPAs
• Perform data trending and statistical analysis; author quarterly reports on environmental and utility data
• Oversee testing for endotoxins, bioburden, growth promotion, EM sampling, and clean utility sampling
• Collaborate cross-functionally with Operations and Facilities to protect aseptic integrity
• Support and coordinate equipment validation, calibration, and maintenance
• Drive compliance with cGMP, FDA, EU, and international microbiology regulations
• Review and author SOPs, support method development, and guide test execution to regulatory expectations

Benefits

• Opportunities for growth and advancement within a science-driven, patient-focused organization
• A collaborative, team-oriented environment with cross-functional exposure
• The chance to make an impact on public health by ensuring the safety of every batch
• Ongoing training and development to keep your skills sharp in a fast-evolving industry

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level