• Senior Manager, Chemistry and Microbiology Labs Operations

    Job Location US-NY-Pearl River
    ID
    2018-4282
    # of Openings
    1
    Category
    Manufacturing
    Type
    Direct Hire
  • Overview

    Overall responsibility for managing the testing activities of the QC Unit Operations, specifically the testing and timely reporting of accurate data for commercial or clinical products and the reporting of data to customers. 

    Responsibilities

    Ensure testing and laboratory procedures are conducted in a manner consistent with cGMP, site and Corporate policies and procedures.  Provides technical guidance, direction and personal development to exempt colleagues.  Functions as an advisor on projects and investigations.  Responsible for ensuring the quality of work within the assigned group.

    Ownership of site Aseptic Performance Team – cross functional team at the site level responsible for driving Aseptic Processing and Contamination Control Fundamentals to all levels of the organization.

    Primary Contact for QC Lab Operations during Regulatory Inspections.

     

    ROLE RESPONSIBILITIES

    Management (Primary)

    Manage the activities of the Quality Control Unit Operations to ensure testing and timely reporting of accurate data for in-process and final batch samples in a manner consistent with cGMP, site and Corporate policies and procedures.

    Responsible for hiring, training, and development of qualified QC staff to ensure effective testing, reporting, and investigation operations.

    Compliance and Quality Analysis

    Responsible for deliverables related to laboratory investigations (i.e. testing needs, laboratory checklists), for Out of Specification (OOS) results, and out of trend results.  Responsible for ensuring adherence of laboratory operations to implemented corrective and preventive actions to minimize/eliminate OOS results due to laboratory error. 

    Ownership of site Aseptic Performance Team – cross functional team at the site level responsible for driving Aseptic Processing and Contamination Control Fundamentals to all levels of the organization.

    Participates in investigations as needed and resolves quality issues identified.  Identifies complex technical problems and provides guidance and support to lab quality systems development and assignment of appropriate corrective/preventive actions.

    Meet all commitments generated by observations of regulatory agencies and audits in the QC laboratory area that pertain to laboratory testing operations and activities.  Ensure and follow up on implementation of corrective and preventive actions resulting from laboratory investigations.

    Regulatory Query/Filing/ Audit Support

    Provide Query response support as well as information requests from various Boards of Health in support of Regulatory Filings as required.

    Participates in local, research, and corporate compliance audits and works with production to revise as required. 

    Primary Contact for QC Lab Operations during Regulatory Inspections.

    Qualifications

    QUALIFICATIONS

    A minimum of a BS/BA in Biology, Microbiology, Chemistry, Biochemistry, Pharmacy or Engineering. Advanced degree and strong technical background preferred.

    10-15 years experience within Quality Control or other relevant Quality Functions in the pharmaceutical industry. Experience in Aseptic Processing, Environmental Monitoring and Contamination Control required.

    Knowledge of relevant chemical, microbiological, immunological, and biological assays.  General lab equipment.  Equipment troubleshooting.  Direct laboratory experience with chemical or microbiological, immunological, environmental monitoring assays and other types of tests necessary.  Good working knowledge of cGMP, USP, EP and FDA guidelines is necessary.

    Candidates will have prior experience in most, if not all, of the following:

    • Making sound and effective decisions under pressure
    • Managing a Quality function
    • Exposure to Regulatory inspections including primary interactions
    • Ability to effectively work within Quality, and across network channels, to accomplish goals
    • Advancing a quality culture in a manufacturing environment
    • People management

    Knowledge of the following areas are critical for success in the role:

    • ICH and other applicable industry standards
    • Manufacturing environment and processes
    • Advancing a culture of quality
    • Global regulatory environment and processes
    • Quality Control Testing
    • Aseptic Processing and Contamination Control Principles 

    PHYSICAL/MENTAL REQUIREMENTS

    ability to perform mathematical calculations

    ability to perform complex data analysis

    ability to remain gowned/standing in a controlled environment

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

    Ability to gown in controlled environments as needed

     

    #CB

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