Central California Blood Center
Fresno, CA
Under the supervision of the Quality Assurance Director, this individual will be involved in the development of quality metrics and key performance indicators for the blood center, auditing medical/technical operational processes and performance, analyzing and identifying trends in deviation/incident data. Will assist with supplier qualification activities and the maintenance of the qualified list. Will develop, maintain competency, maintain familiarity with the CCBC Quality Plan and ensures compliance with all applicable state, federal laws, regulations and with the standards of the accrediting/certifying agencies. Essential Job Duties: Assists in the review and approval of equipment, blood product and computer system validations including installation qualification, operational qualification and performance qualification; Participation in regulatory/accrediting agency inspections, preparation for and performance of internal process with subsequent reports to center leadership; Responsible for the performance of blood product follow up that affects safety, purity, and product quality by investigating, quarantining, discarding and notifying customers of nonconforming blood products including test results that affect patient/general population safety and prevention or recall of shipped products; Responsible for conducting audits, quality assurance oversight and CLIA regulated laboratories processes and computer processes to verify staff performs tasks per procedure; Performs follow up on corrective action plans submitted in response to problem management, supplier issues, product complaints, and other issues as directed by management; Responsible for the management, development and revision of SOPs, COPs, controlled forms, validation protocols and training plans to ensure that all are current and conform to regulatory practices and guidance’s; Regularly conducts QA training of personnel to SOP, policies and performs GMP training; Manages vendor Supplier Qualifications along with confirmatory testing accreditation and licensure records for our outside laboratory testing facilities. Excellent benefits package including health, dental, vision, life insurance, flexible spending account, 401K, free “evehicle” charging. Click here to apply.