Sharon Weeks

Background

About Sharon Weeks

Quality Manager, 14 years of quality management experience, with 24 years of biomedical/blood services experience. • Motivated team leader and builder, committed to organizational quality and compliance. • Implemented and managed the facility quality system review process for the Donor and Client Support Center of the American Red Cross. • Provide quality oversight and manage nonconformance timelines for review and approval of Root Cause(RC) and Corrective Actions(CAs). • Provide quality oversight and manage the organizations Food and Drug(FDA) Center for Biologics and Experimental Reporting(CBER)reporting timelines. • Implemented and provided management oversight for the consolidation of the organizations BPDR reporting structure. • Perform annual state licensure renewal processing. • Performed and manage facility QA audit functions. • Provide inspection support to internal and external ARC customers • Provide QA oversight for change managment and software validations. • Perform and manage Material Review Boards(MRBs). • Perform QA review and approval of Standing Operating Procedures(SOPs). • Implemented and provided QA oversight for the facilities quality system reviews process. • Provided quality oversight for the facility renovation implementation. • Provided quality oversight for the facilities transition from a paper case file to an electronic case file management system.