• Manager, Microbiology

    Job Locations US-MA-Bedford
    Posted Date 2 months ago(12/20/2019 11:13 AM)
    Job ID
    2019-1287
    # of Openings
    1
    Category
    Quality
  • 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.
    • Develop, implement and maintain the sites EM program.
    • Ensure all testing/assays are performed timely, compliant and have been qualified/validated for accuracy.
    • Interact with Technical Operations and Quality Assurance to manage EM excursions.
    • Perform trend analysis of environmental monitoring data and generates quarterly and yearly trend reports.
    • Lead/manage Environmental Monitoring Excursion Investigations, and Out-of-Specification (OOS) and out of tolerance (OOT) investigations.
    • Accomplishes department objectives by managing staff; planning and evaluating department activities.
    • Maintains staff by recruiting, selecting, orienting, and training employees.
    • Lead/manage deviations, change controls and CAPAs as necessary.
    • Review departmental documentation (e.g., Standard Operating Procedures, test data, deviation and CAPAs). Lead and manage revisions, accepting cross-functional input, as necessary.
    • Provides EM/Microbiological technical QC expertise at site, within and outside of department.
    • Participates in internal and external audits as requested.
    • Follow Good Documentation Practices (maintaining contemporaneous records, filling out logbooks, forms, etc.)
    • Adherence to cGMPs.
    • Perform additional duties as assigned.

    Qualifications

    • Bachelor’s Degree in Life Sciences; Microbiology preferred
    • 8+ years’ experience in the Pharmaceutical industry with prior supervisory experience preferred.
    • Operation in a GMP setting to include use of Good Documentation practices.
    • 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, etc.
    • Knowledge of safe laboratory practices
    • Office and laboratory/clean room evironments 

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