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Manager, QC Microbiology

Ocular Therapeutix
Bedford, Massachusetts, US
Closing date
Jun 13, 2023

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
Responsible for maintaining quality standards for our pharmaceutical and device products by leading and managing day-to-day activities for the Microbiology group. This includes ownership of the Environmental Monitoring program as well as the in-process and release testing of raw materials and drug products. Provides QC microbiological guidance and support throughout the company
  • Provide leadership in the QC organization to ensure compliance, drive improvements and achieve schedule adherence.
  • Establish internal QC Microbiology lab to perform EM viable and non-viable monitoring, purified water testing. Ensure that EM data is trended quarterly and annually and manage EM Excursions.
  • Support all programs (clinical and commercial) with Endotoxin and Bioburden testing in compliance with the compendial requirements.
  • Manage the testing of clinical and commercial products performed at outside testing laboratories.
  • Ensure that all microbiology tests are appropriately qualified/validated for the components and/or drug product formulations
  • Lead/manage Deviations, CAPAs, Out-of-Specification (OOS) and out of tolerance (OOT) investigations for product and Environmental Testing.
  • Maintains staff by recruiting, selecting, and training
  • Cross train all microbiology personnel in all aspects of Environmental Testing, Bioburden and Endotoxin testing
  • Review departmental documentation (e.g., standard operating procedures, results, deviation and CAPAs). Lead and manage revisions, accepting cross-functional input, as necessary.
  • Participates in internal and external audits as
  • Follow Good Documentation Practices (maintaining contemporaneous records, filling out logbooks, forms, etc.)
  • Bachelor's Degree in Life Sciences; Microbiology preferred
  • 8+ years' experience in the pharmaceutical industry with prior supervisory experience
  • Operation in a GMP setting to include use of Good Documentation
  • Familiarity with clean room operational procedures, including gowning, cleaning, certification, and monitoring
  • Knowledge of CFR 210, 211, USP, and FDA/ICH guidance
  • Experience with external regulatory inspections (e.g., FDA)
  • Excellent organizational skills and attention to detail
  • Strong interpersonal, verbal, and written communication skills
  • Computer literacy, proficiency in MS Office, Excel, PowerPoint,
  • Knowledge of safe laboratory practices
Job Summary
  • Job ID: 2023-1652
  • # of Openings: 1
  • Category: Quality

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