|Participates in daily operations of the Quality Systems department including but not limited to:|
· Performs and documents incoming inspections of donor tissues to ensure compliance with product specifications and applicable regulations and requirements. Communicates with tissue partners to obtain additional information as needed.
· Performs the donor information sharing, rejection notices, and donor chart corrections process.
· Performs review of donor charts, infectious disease testing results, procurement culture results, and prepares the donor chart for final eligibility review to the Medical Director.
· Assists with investigations and documentation related to Donor Eligibility of CAPAs, Deviations, Nonconformance Reporting, and Complaints, as directed by Director, Quality Systems.
· Other Quality functions as designated and trained by Management (e.g., Tissue Utilization Records, Quality Review of records etc.).
· General administrative tasks such as filing, organizing etc.
· Support inspections and audits from regulatory agencies, as needed