• Manager, Quality Control Microbiology

    Job Locations US-MA-Bedford
    Posted Date 3 months ago(2/1/2018 8:50 AM)
    Job ID
    2018-1046
    # of Openings
    1
    Category
    Quality
  • Overview

    The Quality Control Manager, Microbiology maintains quality standards for our pharmaceutical and device products by leading and managing day-to-day activities for the Environmental Monitoring program, ensuring the compliance, accuracy and timeliness of specified testing processes (e.g. Environmental Monitoring, identification of bacterial and fungal organisms in support of in-process and release testing, and environmental control).

    Provides QC microbiological guidance and support throughout the company.  Ensures all testing processes and departmental documentation comply with OTX and cGMP regulatory standards.   

    Responsible for creating and/or revising the current environmental program and assisting with further implementation. 

    Responsibilities

    • Development, implementation and maintenance of EM program of clean rooms.
    • Lead EM program and system updates and implementation.
    • Ensures all testing/assays are performed timely, compliant and validated for accuracy.
    • Coordinate species identification with contract lab.
    • Reviews and approves data records.
    • Performs trend analysis of environmental monitoring data and generates quarterly and yearly trend reports.
    • Leads, manages and/or participates in the investigation of deviations, Environmental Monitoring Excursion Investigations, and Out-of-Specification (OOS) investigations in compliance with quality procedures, policies and regulations.
    • Reviews departmental documentation (e.g., Standard Operating Procedures, deviation and CAPAs). Leads and manages 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.
    • Perform additional quality control duties as assigned.

    Qualifications

    • Bachelor’s Degree in Life Sciences; Microbiology preferred
    • 7-10 years’ experience in a cGMP environment in the Pharmaceutical industry.
    • Minimum 3 years direct supervisory experience in a microbiology laboratory.
    • Over 5 years prior supervisory or management experience required.
    • Extensive knowledge of general and specific Microbiological QC testing principles (e.g., bacterial endotoxin, bioburden, microbiological identification, biological indicators, etc.).
    • Knowledge of testing and associated equipment protocols and requirements.
    • Familiarity with clean room operational procedures, including gowning, cleaning, certification and environmental monitoring.
    • Operation in a GMP setting to include use of Good Documentation practices.
    • Ability to lift up to 25 pounds, perform visual inspections and physical testing (dimensional analysis, gel time, etc.).
    • Excellent organizational skills and attention to detail
    • Strong interpersonal, verbal and written communication skills
    • Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
    • Familiar with quality measuring instruments such as calipers, pipettes, balances, microscopes, and Instron
    • Experience with external regulatory inspections (e.g. FDA)
    • Familiarity with clean room operational procedures, including gowning, cleaning, certification and monitoring
    • Knowledge of safe laboratory practices
    • Knowledge of ISO 14644, CFR 210, 211, USP, and FDA/ICH guidance

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