Quality Specialist II

Job description

Responsibilities The Quality Specialist II works to ensure the quality and safety of products and services by applying knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of work processes. The incumbent participates in the implementation and maintenance of the quality management system (QMS), with a focus on one or more program areas, including collection of blood and cellular therapy products, manufacturing and distribution, clinical services, transfusion services, laboratory services, and clinical research, as well as organization-wide support functions such as information systems, facilities, and safety. - Protects the safety of patients and blood or HCT/P donors by taking immediate action with input from a Quality Manager when there is a critical quality issue that warrants a stop to production and/or delivery of products and services. - Contributes to the design and participates in implementation and maintenance of the quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools as assigned. - Independently performs quali...