The Stanford Blood Center is seeking a Quality & Regulatory Affairs Specialist. Under the general supervision of the Director of Quality and Regulatory Affairs, this position will perform the quality and regulatory affairs duties and responsibilities by reviewing department procedures, forms, training documents, product and equipment quality control (QC), change control processes, validations, and assist with development, as necessary. Develop, perform and report departmental, system audits, and safety inspections. Perform Good Manufacturing Practice (GMP) and safety training, trend analysis of events and quality indicators, root cause analysis, process improvement, corrective and preventive actions; maintain compliance by enforcing applicable regulations and standards set by regulatory agencies and submit appropriate reports, when required.
Core Duties include:
Review validation plans, procedures, training documents, PDIF records, product and equipment QC for regulatory compliance and assist with development and training as necessary.
Develop, perform and generate departmental reports and system audits.
Develop, revise, institutional QRA SOPs and training.
Perform GMP, QRA and safety training.
Perform trend analysis of events, complaints, and quality indicators with subsequent performance of root cause analysis, and process improvement.
Write the FDA reportable events, Medical device reports, and ensures timely completion of events.
Act as member of Safety Committee and reports applicable information to department supervisors and staff.
Act as inspection coordinator for the department during external inspections.
* - Other duties may also be assigned
Four-year college degree and a combination of three or more years of experience in blood banking\laboratory or manufacturing with solid familiarity of GMP, safety in a manufacturing setup, and CAL-OSHA regulations is required. Must have exceptional attention to detail, able to exercise flexibility, and prioritize tasks; strong collaboration and effective communication skills both verbally and in writing, able to problem solve, analyze and evaluate complex situations; work independently and initiate improvement ideas to enhance QRA program; proficient in Microsoft Office applications especially Word and Excel; be able to prepare and perform training of staff. One or more of the following are highly desired: MT or Specialist in Blood Banking (SBB) certification, CQA certification, Registered Nurse, knowledge of quality improvement concepts and quality management tools.
Internal Number: 51343
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.