• QA Specialist

    Job Locations US-MA-Framingham
    Job ID
    2018-1346
    # of Openings
    1
    Category
    Quality Assurance/Quality Control
    Type
    Full Time
    Company
    LFB USA
  • Overview

    Through collaboration with QC, Manufacturing, Technical Operation, Validations, Facilities, and other operational departments the QA Compliance Specialist will support continuous improvement and companywide efforts to maintain acceptable levels of compliance with internal procedures, corporate requirements and applicable regulations (i.e. FDA, EMA, etc.).  This position will support the maintenance of quality systems for exceptions management, approved supplier program, and key performance indicator/metrics monitoring program.

    Responsibilities

    • Assist with the monitoring, tracking, and metrics for exceptions programs (i.e. Deviation, Change Control, CAPAs, OOS investigations) and meets regularly with applicable departments to ensure timely closure of events and ensure the exceptions program is maintained in a good level of compliance.
    • Prepare tracking tables and conduct meetings for open exceptions follow up. Support departments with writing of investigations, if needed.
    • Support the quality metrics monitoring program by obtaining, compiling, and graphing metrics for tracking of key performance indicators and the performance of annual product reviews, as needed.
    • Manage the LFB USA approved supplier program: maintain vendor list, ensure vendor qualification and requalification requirements are maintained and current, draft and send questionnaires, track responses to observations and ensure vendor review.
    • Support efforts for the implementation and use of software applications to manage exceptions (i.e. Part 11 Toolkit/Access and TrackWise), as needed.
    • Support the data integrity oversight program.
    • Support the LFB USA inspection readiness program as well as inspections and onsite audits, as needed.
    • May participate in self-inspections and perform regulatory surveillance intelligence gathering.
    • May review technical documentation, such as protocols, reports, technical data for compliance with internal procedures and applicable regulations.  
    • Author and revise Quality Systems Documents.

    Qualifications

    BS degree in a scientific discipline and at least three (3) years of experience working in Quality Assurance with good understanding of GMPs.  Pharmaceutical/biotechnology industry experience strongly preferred. T

     

    he ideal candidate is detail minded, organized, and a pro-active thinker with problem-solving skills and the ability to monitor, compile, graph, and verify data.

     

    Must be able to work with cross-functional teams/departments and drive timelines.

     

    Must possess good written and oral communication skills as well as time management skills.

     

    Proficiency in Microsoft Word and Excel required.

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