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Quality Assurance Coordinator (Non-Software/Non-Tester)

The Eye-Bank for Sight Restoration

Quality Assurance Coordinator (Non-Software/Non-Tester)

New York, NY
Full Time
Paid
  • Responsibilities

    Job Description

    PURPOSE OF POSITION:

    To ensure that the standards and regulations established by the U.S. Food and Drug Administration (FDA), New York State Department of Health (NYSDOH), the Eye Bank Association of America (EBAA) are met and routinely followed as a matter of routine laboratory practice.

    AREAS OF RESPONSIBILITY:

    1. Reviews the EBSR Laboratory Policy and Procedures Manual for compliance with regulations set by the FDA and NYSDOH, as well as Medical Standards established by EBAA.
    2. Reviews donor files for completeness and accuracy.
    3. Reviews laboratory equipment maintenance documentation for compliance.
    4. Submits corrective actions for items found not in compliance, as needed.
    5. Prepares quarterly report identifying items found not in compliance for executive and medical directors’ review.
    6. Seeks Follow-up for Transplant Tissue information biannually. Investigates positive responses from the surgeons. Submits review to medical director for his determination. Completes adverse reaction forms, when deemed suitable by the medical director, and submits them to the EBAA as needed.
    7. Prepares reports to the FDA and NYSDOH for the executive directors signature, as needed.
    8. Corresponds with surgeons and EBAA when contrary serology results are received from other transplant agencies, as needed.

    SCHEDULE: MONDAY THROUGH FRIDAY 8AM - 4PM

    REQUIREMENTS:

    • Bachelor of Science
    • Computer literacy
    • Previous experience with quality assurance procedures

     

     

    Company Description

    The Eye-Bank for Sight Restoration is the world's first eye bank. Established in New York City in 1944, it is a private, not-for-profit organization devoted to restoring sight through eye donations and cornea transplants, as well as providing ocular tissue for research into treatment and cures for other eye diseases. Since The Eye-Bank was founded, the pioneering organization has helped provide the beautiful gift of sight to more than 65,000 individuals who would have otherwise been blind. Today, The Eye-Bank is a leader in the field, operating a state-of-the-art Ocular Laboratory and employing advanced techniques in preparing donor tissue for successful transplant surgeries. The Eye-Bank also provides eye tissue to patients in need of life-enhancing, reconstructive surgery.