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Sanford

    Clinical-Scientific - Investigator Initiated Research (IIR) Associate - Sanford, United States - Pioneer Data Systems

    Pioneer Data Systems
    Pioneer Data Systems Sanford, United States

    1 week ago

    Pioneer Data Systems background
    Description

    Position Details:

    Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Quality Engineer to join their expanding team.


    Job Title:
    Quality Engineer / Pharma Manufacturing Investigations
    Duration: 18 months contract, extendable up to 36 months


    Location:
    Sanford, NC


    Note:

    The client has the
    right-to-hire you as a permanent employee at any time during or after the end of the contract.


    You may participate in the company group
    medical insurance plan


    Job Description:

    The Sanford Engineering Systems investigation team is responsible for completing investigations for equipment/instrument failures along with human root causes when engineering personnel are involved.


    This position will report to the site's Engineering Systems Lead.

    The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.

    The individual will be expected to develop collaborative relationships with the colleagues within Engineering, Maintenance and Utilities (EMU) and the appropriate Quality representatives in order to facilitate investigations using common investigation tools (5 whys, fishbone diagrams, etc.).


    The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of the appropriate regulations.

    To know what facts you require, can separate out opinions from facts, use investigator tools to determine root cause, get area owner and Maintenance agreement, author the technical report, and obtain QA approval all under 30-days.

    Investigators juggle up to 7 investigations simultaneously.

    This is a very intense job that requires competence. Quickly adapt and learn client's methodology and work independently.


    Additional responsibilities and expectations include:
    Have a fundamental understanding of the investigation process as it applies to manufacturing issues

    Have general understanding of equipment, instruments and systems involved in the manufacture of bio pharmaceutical.

    Be able to use that knowledge to investigate deviations to identify root cause.

    Be able to interview subject matter experts.

    Work with the appropriate people develop a corrective action

    Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards


    Required Skills:

    • Compliance Investigations (Working experience vs familiarity)
    • All MS Office Products and Outlook including Teams
    • Excellent Technical Writing Skills, Communication - Written and Verbal,
    • Detail Oriented/Organized

    Preferred Skills:

    • Experience completing investigations is highly desirable.
    • Experience with Veeva Vault is a plus.

    Interview Process:
    Panel Interview via Teams


    Comments:
    They need competence in the basic foundations prior to hire, ready to hit the ground running


    Minimum Education:
    BA/BS
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