WuXi AppTec

  • Quality Assurance Specialist

    Job Locations US-PA-King of Prussia
    Job ID
    2019-5865
  • Overview

    WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. Searching for a Quality Assurance Specialist that will be responsible for daily inspections and ensure manufacturing operations maintain company and global industry standards.

    Responsibilities

    • Responsible for daily inspection to ensure the effective execution of operation procedures and batch records
    • Communication between QA and other departments, report problems in time
    • Participate in manufacturing related deviation, change, CAPA and OOS
    • Cooperate with self - inspection, customer and regulatory audit
    • Participate tech transfer process and review protocols and reports
    • Review and double check all original materials before submit to official

     

    Qualifications

    • Minimum Bachelor degree in biology, biotechnology, or relevant discipline
    • Minimum 5 years quality experience, preferable in vaccine Lab or commercial product experience
    • Understanding of cGMP/GLPs and ICH in the pharmaceutical industry well
    • Good interpersonal skills and the ability to communicate well

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