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Scientific. Clinical. Software Engineering

RN - Drug Safety

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -042019-24618 Region: Edison-New Brunswick Metro Area

Job Description

  • QA Safety RN
  • Education and Experience:
    RN license with BSN or BS in Life Science w/ recent experience as an RN - This position requires the candidate to have a New Jersey RN License.
    Job Summary:
    Responsible for maintaining compliance with FDA, AATB, international and state regulations during the second level quality review of all tissue donor files for tissue to ensure the safety of donated human tissue.
    Responsible for the triage and review of information received after initial donor release to assess the potential impact on donor suitability and distributed products, triggering escalation procedures and evaluation for regulatory action.

    Key Duties and Responsibilities:
    Reviews information contained in donor files to ensure compliance with all applicable FDA and International regulations as well as AATB Standards. Utilizes clinical knowledge of acute / critical events to identify missing or ambiguous donor information to facilitate comprehensive review of donor file.
    Reviews information received after donor release by the Medical Director in order to assess the impact on donor suitability and potential nonconforming product in distribution. Appropriately places human tissue products in quarantine as needed.
    Performs retrospective reviews as required to assist with audits and investigations as requested, including external audits of human tissue products.
    Assist with the creation of SOPs and any other activities needed by the department.

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