The Sr. QA Specialist will be Responsible for the quality oversight in investigations of Blood Products Nonconforming Events and Corrective and Preventive Actions (CAPAs). Investigates recalls and lookback notifications for blood products. Perform final QA review of manufacturing and laboratory records to ensure thoroughness, accuracy and validity.
- Lead/perform internal audits, development history file audits, manufacturing line audits, data integrity audits, supplier audits.
- QA review of manufacturing records and final product release
- Manage blood products inventory in Quarantine locations
- Assists in identifying and initiating Nonconforming events and corrective and preventive action activities
- Assist in external quality system audits
- Follows company policies and procedures
- Evaluated and elevates indicator of trends in products/processes
- Creates and updates procedures, as assigned
- Monitors approved supplier's performances
- Assists in supplier qualification activities, as needed
Sthree US is acting as an Employment Business in relation to this vacancy.