• LFB USA - QC Manager

    Job Locations US-MA-Framingham
    Job ID
    2018-1342
    # of Openings
    1
    Category
    Quality Assurance/Quality Control
    Type
    Full Time
    Company
    LFB USA
  • Overview

    The Manager of Quality Control plays a key role in managing testing in the Analytical & Molecular lab across all product lines in accordance with FDA and European Guidance for QC laboratories. Requires considerable judgment and skills to identify and rectify test method problems and make recommendations for corrective action necessary to assure conformity with Quality specifications.

    Responsibilities

    • Manages testing of raw materials, in-process samples, bulk and finished products and stability samples in conformity to standards and approved specifications, and on timelines to meet targets for product release.
    • Responsible for life cycle management of critical reagents, reference standards and assay controls.
    • Manages method transfer, validation and qualification activities within Quality Control.
    • Responsible for development, implementation and maintenance of Quality Control systems.
    • Provides plans for new projects, processes and method development needs in conjunction with Technology Transfer and R&D.
    • Implementation and monitoring of statistical process control for In-Process and final product release assay data.
    • Implementation and monitoring of statistical trend analyses for test methods, invalid assays, assay controls and reference standards.
    • Creates trend reports and assist with data extraction, data reviews and annual method performance assessments.
    • Authors and reviews Certificate of Analysis for product dispositions for products manufactured by LFB USA.
    • Coordinates with contract manufacturers and laboratories to support testing activities.
    • Manages Quality Control Staff to include goal setting, performance appraisals, and professional development.
    • Ensures training on new methods, SOPs and other technical requirements is completed for all Quality Control staff.
    • Approves changes to Quality Control and production processes and materials to meet specifications, optimize efficiencies and control costs.
    • Develops budgets for staff, equipment and supplies and monitors expenditures.
    • Serves as a member of the Quality management team and provide both management and leadership to a team of technical, professionals and administrative staff.
    • Plans and implements the actions necessary to ensure that the department operates within the appropriate guidelines, timelines and budget.

    Qualifications

    Education: BS degree in Biology, Chemistry or related science required with Master’s degree preferred.

    Experience: Requires a minimum of 5+ years’ experience in a FDA regulated Pharmaceutical/Biotechnology industries in a quality control GMP environment with prior supervisory experience.

    Skill sets:

    • Expert in chemical analysis methodologies, including chromatography (HPLC/GC), spectrophotometric (UV-VIS), electrophoresis (SDS-PAGE), ELISA and general wet chemistry methods.
    • Extensive knowledge of cGMP/ICH/FDA/EU regulations and guidelines is required.
    • Extensive knowledge of chromatography software such as Empower or Chemstation, statistical analyses software such as JMP is required.
    • Experience with QMS systems a plus.
    • Technical writing experience related to SOP protocols and technical reports necessary.
    • Must communicate well and exhibit a high level of initiative, competence and professionalism.
    • Ability to lead a high performing team with many and multiple priorities.

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