• LFB USA - QA Compliance Specialist

    Job Locations US-MA-Framingham
    Job ID
    2018-1321
    # of Openings
    1
    Category
    Quality Assurance/Quality Control
    Type
    Full Time
    Company
    LFB USA
  • Overview

    The Quality Assurance Specialist will perform a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting data and document reviews and analysis. Writes and revises SOPs and related manufacturing documents. Will review investigations related to manufactured product. Works on problems of complexity and diversity in which analysis of data requires in depth evaluation of various factors.

    Responsibilities

    • Conducts data and documentation reviews and analysis. Collaborates with other departments for investigations, EM alerts, change controls, deviations, and corrective resolution.
    • Coordinate and assist with batch record review and data auditing for quality assurance, manufacturing support and product dispositions for products manufactured by LFB USA. May assist with record review for release of final product.
    • Interfaces with Manufacturing, Technical Operations and Quality Control.
    • Coordinates, prepares and approves the process documentation for QA release of intermediates and source materials.
    • Ensures Corrective Actions are implemented and assists in investigation of root cause.
    • Conducts compliance review of Quality Control assays in accordance with site procedures.
    • Ability to be person in plant for QA at CMOs.
    • Keeps management team informed of the operations, progress and performance.
    • Develops and maintains the Operational KPIs for management review.

    Qualifications

    BS degree in a life science/scientifically related field and a demonstrated knowledge of scientific principles. Minimum of 6 years related work experience in a regulated environment, five years’ experience with lot release functions. Experience in technical writing and the ability to interface with internal clients is a must. Ability to effectively prioritize in a changing environment. Must be able to function independently with minimal direct supervision.

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