Stanford Blood Center is seeking a QA Specialist to work in the Technical Services Laboratory. Under the general supervision of the Operations Support Supervisor, the QA Specialist will perform the quality assurance duties of the Technical Services department by writing/revising department equipment and process validation plans, managing equipment preventative maintenance program, manage training records, perform process and computer audits, write/revise procedures for regulatory compliance as necessary. Prepare training binders for new staff and monitor new and incumbent staff training is up to date. Ensure annual SOP and label review performed, review departmental records, help determine corrective actions for events by performing root cause analysis, and is involved in process improvement. Perform post-donation information follow-up that affects safety, purity, and quality of the product by quarantine/discard of units, notification of customers and tracking of recalls. Provide notification to hospitals, regulatory agencies and other customers of test results that affect patients/general population safety.
Bachelor’s degree in a related field. Minimum 1 years’ experience in GMP environment required, Blood Center experience preferred. Clinical Laboratory Scientist (MTA) or Certified Quality Auditor (CQA) preferred but not required. Ideal candidates will possess: demonstrated ability to train staff; quantitative and qualitative data analysis skills; basic understanding of current Good Manufacturing Practices (cGMP) and application in work setting; demonstrated organizational skills and detail orientation and ability to manage competing priorities; ability to effectively communicate orally and in writing with diverse audiences; ability explain technical concepts clearly and concisely; ability to maintain appropriate current knowledge of and interpret specific government agency requirements (statutes, regulations, licenses, and permits); and ability to work independently and with minimal supervision.
Internal Number: 58277
About Stanford Blood Center
Community blood center and Histocompatibility, Immunogenetices and Disease Profiling Laboratory serving 5 hospitals in San Francisco Bay Area, including large transplant/trauma center. Stanford Blood Center is an affiliate of Stanford Health Care.