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    Duties

    Summary

    This Direct-Hire position is in the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS). The Quality Assurance Manager (Biologist/ Chemist) is the front line focal point to implement, develop and maintain ORA Quality Management Systems (QMS) in their laboratory.

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    Responsibilities

    • Apply expertise in advanced professional theories, principles, concepts, standards, and methods sufficient to conceive and apply experimental theories and new development applications.
    • Identify training needs, establish objectives, and coordinate development of overall training plans for the laboratory.
    • Develop innovative ways of conducting business which may include authoritative recommendations on instrumentation and other technical modifications, reprogramming of resources, or changes to existing quality assurance programs.
    • Responsible for the development and maintenance of a quality control/assurance program that assures quality work products and offers clear guidelines and quality standards.
    • Apply quality control systems and quality assurance methods to determine risks and compliance standards for work and implement associated risk mitigation actions.
    • Advise senior colleagues and agency officials and manage significant projects that represent an important segment of the agency's operating programs.
    • Work with laboratory management in guiding, coordinating, and monitoring the overall quality of work products and laboratory management systems.
    • Write summaries and reports addressing such areas as problems and deficiencies, corrective action taken, and recommendations for strengthening and improving programs.

    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/614525200. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.