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Marietta

    Associate Compliance Analyst - Marietta, United States - WAPT

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    Description

    Overview:

    WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Quality Department for an Associate Compliance Analyst.

    Shift is Tuesday - Saturday

    Responsibilities:
    • Review laboratory worksheets and electronic records
    • Review, sign, and send final reports to clients
    • Interact with clients regarding final report status and report amendments
    • Contributes to the overall operations and to the achievement of departmental goals
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
    • Works under supervision from supervisor or senior personnel
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
    • May be required to work holidays and weekends
    • May be required to work overtime
    • May be required to assist in other departments
    • Other duties as assigned
    Qualifications:
    • Experience / Education
      • Associates or Bachelors Degree or equivalent experience
      • 2 years comparable experience in a regulated industry or 4 years without degree
      • Prior QA/QC experience in electronic record review (i.e. LIMS, batch records) preferred
      Knowledge / Skills / Abilities:
      • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
      • Ability to work in a team environment and independently as required
      • Must have strong attention to detail and the ability to maintain focus
      • Must be diligent, organized, and dependable
      • Proficient in oral & written communication skills
      • Need to be able to read, write and understand English
      • Proficient in computer programs ( e.g., Microsoft Office)
      Physical Requirements:
      • Must be able to work in an office environment with minimal noise conditions
      • Must be able to wear appropriate PPE when required
      • Ability to sit for long periods of time

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled


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