Stanford Health Care
Technical Services QA Specialist
Palo Alto, California
Stanford Blood Center, a subsidiary of Stanford Health Care, is focused on connecting our communities to provide hope for healing. We lead the fields of transfusion and transplantation medicine by advancing science and technology. We provide hope for the future by teaching the medical leaders of tomorrow. We enhance lives by connecting donors to patients every day. We are looking for friendly, customer-focused individuals who value integrity, accountability, collaboration and communication, to join our team.
We are a 24/7 fast-paced organization that is highly regulated by the FDA, ASHI and a number of other accrediting agencies. We need people that are dependable, detail-oriented and comfortable following established procedures. For more information about us, visit our website at http://bloodcenter.stanford.edu/
We are seeking a QA Specialist for the Technical Services laboratory. Under the general supervision of the Technical Services Director, perform the quality assurance duties of the Technical Services department by writing/revising department equipment and process validation plans, managing equipment preventative maintenance program, perform process and computer audits, write/revise procedures for regulatory compliance as necessary. 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.
Core Duties include:
Write/revise/review equipment, process validation plans, and procedures, as necessary. Ensure annual review is completed for all departmental procedures (SOPs), forms and labels.
Review department records for accuracy and ensure they meet acceptance criteria, including state and federal regulatory guidelines and internal policies. Manage equipment preventative maintenance program.
Review/discard/release blood products from quarantine based on review process. Perform hospital/customer/county and state notification of infectious disease exposure.
Perform audits of laboratory and computer processes to verify staff performs tasks per procedure.
Perform root cause analysis for events and determine corrective action, monitor trends, and initiate process improvement as needed. Ensure timely completion of event reporting, quality indicators, and corrective action plans.
Act as member of Safety Committee and performs inspections of the department to ensure Health and Safety compliance.
Act as inspection coordinator for the department during internal and external inspections.
* - Other duties may also be assigned
Bachelor's degree in a related field. Minimum 2 years' experience in GMP environment required, Blood Center experience preferred. Clinical Laboratory Scientist (MTA) or Certified Quality Auditor (CQA) preferred.
Other Relevant Information:
Will be required to comply with governmental regulations and Blood Center policy and strictly observe privacy and security related policies, procedures and practices to preserve the integrity and confidentiality of medical and other sensitive information pertaining to donors, patients, research subjects, and staff. May be required to enter areas where other individuals work with human blood; potential may exist for unanticipated exposure to bloodborne pathogens by splash or spill.
Final offers of employment are contingent upon the successful completion of:
A background check that includes employment history, national criminal background check, national sex offender registry search and, where applicable, a credit check and/or driving record.
A pre-placement physical exam that includes TB testing and drug/alcohol screening.
We are not able to provide relocation or sponsorship for this position. Stanford Blood Center is an affirmative action, equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status or on the basis of disability.
Thank you for your interest!
At Stanford Health Care, we seek to provide patients with the very best in diagnosis and treatment, with outstanding quality, compassion and coordination. With an unmatched track record of scientific discovery, technological innovation and translational medicine, Stanford Medicine physicians are pioneering leading edge therapies today that will change the way health care is delivered tomorrow.