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Manager, QC Microbiology

Employer
Ocular Therapeutix
Location
Bedford, Massachusetts, US
Salary
Competitive
Closing date
Jun 13, 2023

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
Overview
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
Responsibilities
  • 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.)
Qualifications
  • 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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