PCI Pharma Services · 2 days ago
Supervisor, QC Microbiology
PCI Pharma Services is a company focused on life-changing therapies and global impact. The Supervisor of QC Microbiology will be responsible for overseeing the daily operations of the QC Microbiology laboratory, ensuring timely testing and release of samples, and maintaining compliance with cGMP standards.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Supervise lab personnel and provide oversight for personnel work schedules
Mentor and develop staff to meet technical and business needs
Perform trending and data analysis with appropriate statistical evaluation of environmental monitoring and water/clean steam data for NH PCI facility sites and write quarterly reports summarizing these data
Perform and document investigations into Environmental Monitoring excursions and incidents which occur during aseptic filling and routine monitoring
Perform risk assessments and investigations with effective CAPAs
Work with and provide input to Operations and Facilities groups to maintain the sterility or aseptic nature of processes
Performs initial identification of microbial contaminants and/or isolates
Oversee and perform as necessary endotoxin, bioburden, growth promotion of media, environmental monitoring, and critical utilities collection and testing
Coordinate and support validation, calibration, and maintenance of microbiology laboratory equipment and instrumentation
Maintain positive relationship and network effectively across sites, organizations, and clients
Ensure cGMP compliance of all activities performed and on time delivery of quality results
Write and review standard operating procedures and coordinate method development and validation of microbiological methods
Work and guide personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with regulatory guidance
Qualification
Required
Alternatively, a BS Degree in Microbiology, biology or similar life science with greater than 5 years of intensive experience may be considered
Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology
Preferred
Master's Degree in Microbiology, biology or similar life science preferred with at least 3-5 years' experience in Pharma or Biotechnology Quality Control cGMP
Previous experience in aseptic manufacturing highly preferred
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
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
Recent News
2025-07-22
Company data provided by crunchbase