The Quality Engineer will execute Blood Product quality validations concerned with development and manufacturing. Assist in quality development and review of specifications, manufacturing procedures, plans, protocols, reports. Quality review/release of blood products.
- Drafting/writing of plans, protocols and reports for development to support qualification of blood products and associated items
- Perform characterization and validation studies for new blood products and assists in review of development data
- Assist in test method validation, as needed
- Collaborates on critical manufacturing related processes and decisions
- Assesses proposed changes to blood product specifications, processes and procedures for impact related to product approvals/qualifications
- Follows company policies and procedures
- Investigates deviations from procedures and specifications related to development and manufacturing of blood products and provides input for appropriate corrective actions
- Partners with manufacturing to solve issues/problems that may occur
- Partners with Quality Systems in supplier management activities
- Supports Annual Product Review activities, as needed
- Other duties as assigned
Sthree US is acting as an Employment Business in relation to this vacancy.