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    Center Medical Director - Cleveland, United States - Kedrion Biopharma - USA

    Kedrion Biopharma - USA
    Kedrion Biopharma - USA Cleveland, United States

    3 weeks ago

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    Description

    KedPlasma is seeking a dedicated Center Medical Director to join our team, focusing on ensuring the highest standards of donor safety and welfare. This pivotal role involves comprehensive oversight of donor assessments through a detailed history and physical examinations, informed consent, adept management of donor reactions, thorough evaluation of laboratory results, and immunizations. The ideal candidate will operate within the stringent guidelines of the EU Guidance on Good Manufacturing Practice and the FDA's cGMP 21CFR, ensuring excellence in donor care and safety.

    Key Responsibilities:

    • Conduct and oversee the annual recertification of Medical Supervisors, ensuring continuous compliance and excellence.
    • Review donor laboratory data and collection records in alignment with 21CFR 640.65, maintaining donor suitability.
    • Authorize and review abnormal SPE/RPR Test Profiles, along with all other irregular laboratory test results, weekly.
    • Make informed decisions regarding donor suitability, especially in cases of abnormal laboratory findings.
    • Conduct regular reviews of SPE/RPR Test Profiles and Medical Qualifications to ensure the highest standards of donor care.
    • Adhere to all facility SOPs, FDA and EU regulations, OSHA, CLIA, and COLA requirements, with meticulous documentation of compliance. Proficiency in CLIA Proficiency Testing requirements is essential.
    • Be present during donor red cell stimulation procedures, ensuring safety and compliance.
    • Assess donor suitability, especially in borderline screening values or after significant absences from the plasmapheresis program.
    • Refer donors to external medical facilities as necessary, acting as a liaison to ensure seamless care.
    • Supervise or perform donor immunizations in compliance with 21 CFR 640.66, managing and treating any adverse reactions.

    Requirements:

    • Valid medical license (M.D. or D.O.) in the state of operation, with a commitment to maintaining licensure.
    • Experience with desktop computing and secure system navigation. Proficiency in Microsoft Office, Outlook, Internet Explorer, and patient databases (e.g., CTMS, EMRs, DMSs).
    • Comfortable working in a seated position and exposure to bloodborne pathogens, with appropriate PPE.
    • Availability for consultation on donor suitability and medical emergencies.

    Position Details

    • Full Time
    • Medical Specialties: Including but not limited to Addiction Medicine, Cardiology, Emergency Medicine, and many more.
    • Location: Cleveland, TN
    • Education: Doctorate (Required)
    • License/Certification: Medical Doctor's license (Required)
    • Willingness to Travel: 25% (Preferred)
    • Work Location: In person

    This role is not just a job but a vital contribution to the health and safety of our community. If you are passionate about making a difference and possess the required qualifications, we would love to hear from you. Join us in our mission to ensure the highest standards of donor care and safety. Apply now to become a part of our dedicated team.

    Kedrion Biopharma & KEDPLASMA offer many benefits to qualifying employees, including:

    • Medical, vision and dental insurance
    • Life and AD&D insurance
    • Paid holidays
    • PTO accrual
    • and much more

    KEDPLASMA provides a friendly and rewarding working environment with frequent opportunities for cross-training and advancement. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

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