PCI Pharma Services · 1 day ago
Supervisor, QC Microbiology, Second Shift
Bedford, NH
Full-time
Onsite
Senior Level
5+ years expPCI Pharma Services is a global leader in providing life-changing therapies and is seeking a QC Microbiology Supervisor to oversee daily lab operations. The role involves managing a team of microbiologists, ensuring compliance with regulations, and performing various microbiological testing and analyses.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Lead daily lab operations—including oversight of environmental monitoring, microbial testing of utilities (USP , , ), 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
Qualification
Required
Master's degree in Microbiology, Biology, or related life science
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
Preferred
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
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
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase