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    Duties

    Summary

    These Quality System Specialist positions are located in the Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS). ORA protects consumers & enhances public health by maximizing compliance of FDA regulated products & minimizing risk associated with those products. ORS provides strategic leadership, coordination, & expertise on scientific issues related to policy & regulations.

    Positions may be filled in the locations listed. Duty station will be determined upon selection.

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    Responsibilities

    • Develops and maintains segments of a quality control/assurance program that assures quality work products and offers clear guidelines and quality standards.
    • Participates in facilitating internal and external scientific audits.
    • Provides information for all audits or leads audits, as necessary.
    • Assists the Quality Systems Manager with identifying training needs from quality system results and develops training plans to satisfy those needs.
    • Monitors all ancillary equipment to meet all requirements laid out by the international standard in assigned areas.

    Travel Required

    25% or less - You may be expected to travel for this position.

    Supervisory status

    No

    Promotion Potential

    None

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/607770800. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.