WuXi AppTec

  • Technical Operations Specialist (Facilities - Tech Writer/Documentation)

    Job Locations US-PA-Philadelphia
    Job ID
    2019-5630
  • Overview

    The Facilities Technical Operations Specialist will generate and/or review Facilities related technical documents and manage timely closure of these documents. This includes but is not limited to Non-Conforming Event (NCE) investigations, Deviations, CAPAs and Change Controls (CC).

     

    The Facilities Technical Operations Specialist will also assist with the generation and maintenance of facilities related standard operating procedures (SOPs).

    Responsibilities

    • Execute NCE investigations ensuring complete and thorough review and timely closure (target <30 days from initiation).
    • Manage changes having GXP impact including process, equipment, and facility changes through WuXi’s Change Control process.
    • Develop and maintain quality metrics around NCEs, Deviations, CAPAs and Change Controls.
    • Provide support writing SOPs and other technical facilities documents and forms as required.
    • Evaluate trends in NCEs and recommend CAPAs.
    • Work with appropriate departments for efficient management of NCEs, CAPAs and CCs. This includes QA, SAEM, Metrology, Validation, Facilities, Testing, PD, AD and Manufacturing.
    • Performs other duties and responsibilities as assigned.

    Qualifications

     

    Experience / Education

    • High School diploma and at least 6 years of relevant experience in the biopharmaceutical industry or Bachelor’s degree and 4 years of experience in a regulated facility or equivalent.
    • Experience executing Change Controls and performing NCE investigations in a GMP manufacturing environment and generating reports to high quality standards.
    • A thorough knowledge of CMMS
    • Technical writing skills a plus.


    Knowledge / Skills / Abilities:

    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)

     

    Our Values:

     

    Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

     

    Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

     

    WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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