Chhavy Thang Email & Phone Number

Greater Los Angeles Area

Monitors blood center systems and procedures for compliance with State and Federal RegulationsOversees day-to-day activity of quality assurance staff and departments reporting to QAReviews new/changed regulations and evaluates impact on blood center Coordinates the implementation of regulatory or manufacturing changes Provides guidance on regulatory standards and strategies for complianceManages preparation of FDA Registration, State Biologics and Clinical Lab LicensurePrepare and submit blood product and label submissions to the Food and Drug AdministrationManage or involvement in process improvement activities/projectsInterfaces with regulatory and accreditation agenciesPerforms review of deviation events and assists management in root cause analysisEvaluates the quality and safety of nonconforming materials with MD in a Material Review Board Performs tracking, trending and data analysis of quality indicators

Planned and conducted organizational audits for compliance with regulations and standardsWrote quality management standard operating procedures (SOPs) for the organizationReviewed and approved new or changed SOPs from operations/manufacturingPrepared submission of prior approvals, 30-day notifications or annual reports to the FDAPerformed investigation of blood product deviations and submitted reports to regulatory agenciesReviewed validations, verifications, qualifications and quality control recordsPresented cGMP, quality and regulatory presentations at new hire orientation and manager’s meetingLead inspectors from regulatory or accreditation agencies during external inspectionsPrepared reports and audit responses for submission to senior management and external agenciesProvided regulatory and quality guidance to blood center and laboratory staff

Wrote SOPs on the usage, quality control, and preventative maintenance of equipmentExecuted new medical devices testingPerformed validations on procedures, processes and equipmentInteracted with vendors and top management in the selection of new medical devicesProvided interdepartmental guidance and customer service

Performed quality control and preventative maintenance on medical devicesMaintained accurate, detailed and well organized records of all equipment activitiesAssisted in writing standard operating procedures and performing validations

Master Of Business Administration (M.B.A.), Concentration In Marketing

Bachelor Of Science (Bs), Health Science

Activities and Societies: Vice President, Student Association @ CSUF Fullerton, Ca (September 1999 – June 2000)