WuXi AppTec

  • Quality Systems Specialist

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3581
  • Overview

    Responsible for administering Document Control processes, including: issuance, tracking, implementation, obsoletion, and archival of all controlled document types, while ensuring accordance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) for Laboratory Studies.

    Responsibilities

    • Primary role is managing the day-to-day aspects of the Archival process, which includes record retention, obsolescence, and archival.
    • Coordinates training documentation. Specifically, is responsible for creating training modules for new employees based on functional management input. Reconciles training documents for completeness and grading, where applicable.
    • Administers the Document Change Process, includes assigning tracking numbers in accordance with corporate field support, issuing appropriate documentation, tracking document status and making documents effective upon completion of training requirements, as required.
    • Performs the issuance, maintenance and archival for controlled documents. Including, but not limited to: SOPs, Log Books, Batch Records, Training Records, Cleaning Records etc.
    • Ensures document maintenance is adhered to. (i.e.: biennial SOP reviews)
    • Provides and prepares documentation and materials for/in various reporting forums for internal and external customers.
    • Leads and/or participates in Quality System reporting forums assessing compliance with cGMP and other applicable regulations.
    • Performs other duties as required
    • 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.
    • Works under close supervision from supervisor or senior personnel.
    • Ability to work in a team environment and independently as required
    • Maybe required to work Holidays and weekends
    • May be 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
    • Performs other duties as assigned

    Qualifications

    Experience / Education:

    • 3-5 years of relevant experience or equivalent
    • Bachelors’ degree in a Science related field or equivalent experience

    Knowledge / Skills / Abilities:

    • 1 year GXP experience - or equivalent training and/or experience.
    • Ability to accomplish the described duties through the use of appropriate computer equipment and software (especially Microsoft Word, Excel, and Outlook).
    • Must be proficient in multitasking and time management.
    • Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
    • Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
    • Ability to use judgment as dictated by complexity of situation.
    • Proficient in Oral & Written communication skills

    Physical Requirements:

    • Must be able to work in an office environment with minimal noise conditions.
    • Must be able to work in Lab setting with Biohazards /various Chemicals
    • Must be able to work in environment with variable noise levels
    • Ability to stand /Sit/walk for long periods of time

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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