SUMMARY OF DUTIES:
- Conducts internal audits and ensures follow-up corrective action. Acts as a liaison for external inspections.
- Coordinates and performs product lookback activities, including monitoring of daily quarantine reports. Maintains donor deferral notification records and letters.
- Performs document management activities and Form control. Writes or revises Standard Operating Procedures as assigned.
- Maintains, orders and distributes Donor ID Numbers (DINs), product labels and O Reports.
- Acts as the contact person for CE Broker, including the provision of CEU credits for continuing education activities.
- Oversees the Critical Equipment and Critical Suppliers lists and directs bi-annual supplier qualification.
- Monitors the Self-Exclusion Hotline, including follow-up activities as needed.
- Perform contract management and maintain the contract database.
- Assists with the Error Management and Donor Adverse Reactions databases, including follow-up investigation.
- Writes and performs validation activities prior to implementation of new processes, equipment or software version updates.
- Acts as a back-up to the QA Director, including completion of special projects as assigned.
- Acts as a back-up for the duties of all aspects of the quality assurance program.
- Participates in activities to further professional development. Accepts speaking engagements.
Hours or Shift:
Full-Time. Regular business hours and as need
Bachelor’s degree in Medical Technology or equivalent experience
None; FL licensed Medical Technologist preferred