WuXi AppTec

  • Technical Operations Specialist I

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3491
  • Overview

    The Documentation Specialist will generate and/or review Manufacturing related technical documents and manage timely closure of these documents.  This includes but is not limited to Non-Conforming Event (NCE) investigations, CAPAs, Change Controls (CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP).  

    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.
    • Provide support writing SOPs as needed.
    • Work with appropriate departments for efficient management of NCEs and CCs. This includes QA, Metrology, Validation, Facilities, and Manufacturing.
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
    • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
    • Ability to work in a team environment and independently as required
    • Maybe required to work Holidays and weekends
    • Maybe required to work Overtime 
    • Contributes to the overall operations and to the achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
    • Other duties as assigned
    • May be required to assist in other departments

    Qualifications

    Experience / Education   

    • 2 years of relevant experience with a High School Diploma or 1 years of experience with a Bachelors’ degree
    • High school diploma or Bachelors’ degree or equivalent experience

     

    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)

     

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled 

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