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Supervisor, QC Microbiology, Second Shift

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PCI Pharma Services

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Location:
United States , Bedford

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • Master’s degree in Microbiology, Biology, or related life science (preferred)
  • 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 have:

  • 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
What we offer:
  • 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

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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