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Exton

    Quality Control Lab Manager - Exton, United States - Beacon Hill

    Beacon Hill
    Beacon Hill Exton, United States

    3 days ago

    Default job background
    Description

    General Responsibilities:

    Directs the Quality Control functions and provides direct support of all Quality Control processes, test procedures, and procedure validation activities. Measures, generates and evaluates data for the Certificates of Analysis to support the disposition of manufactured Bulk Drug Substance and Drug Product Injection lots. Works in conjunction with the Analytical Development team to optimize and transfers test procedures to the Quality Control department.

    Responsibilities:

    Manage a staff of Quality Control analysts and Environmental Monitoring specialists ensuring that day-to-day scheduling of activities is appropriately resourced

    Maintenance of the viable and non-viable Environmental Monitoring Program, including monthly trend analysis, yearly alert and action level evaluation, equipment upkeep, logbook review, and order status

    Manage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systems

    Ensure all method validation is current. Test procedures include bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays

    Keep apprised of compendial changes and ensure compliance with compendia for all test procedures

    Manage external vendors providing lab services and materials

    Maintain appropriate inventory of materials through effective order management, coordination with Finance, and adherence to departmental budget

    Ensure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final drug product

    Participate in the establishment of phase-appropriate specifications

    Ensure data integrity is maintained for all applications, programs, and executed work

    Generation of protocols and technical reports

    Author and manage QC change controls, test procedure revisions, SOP revisions, laboratory investigations, and root cause analyses

    Raise critical quality issues to upper management

    Perform internal audits to ensure compliance with cGMPs

    Write and revise Quality Systems SOPs as necessary to maintain compliance

    Training and development of employees

    Ensure full compliance with applicable health and safety regulations (such as OSHA)

    Willingness to engage with a high energy team in pursuit of organizational goals and strategies

    Computer Skills:

    To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.

    Education:

    Minimum Bachelor of Science degree in a scientific discipline

    Experience:

    Minimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management experience in Quality Control or Quality Assurance

    Excellent knowledge of cGMP guidelines, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standards

    Writing experience in a similar role in the biologics or pharmaceutical industry

    Experience in aseptic processing and/or mammalian cell culture production

    Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills

    Ability to prioritize and successfully execute multiple tasks simultaneously

    Ability to work with a high degree of accuracy and detail

    Positive work attitude that supports teamwork and continuous improvement

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