Professional Quality AssuranceJob Locations

　　US-IL-Aurora | US-WI-Milwaukee | US-IN-Indianapolis | US-MI-Grand Rapids

　　ID 2023-9353  

　　Category Quality  

　　Position Type Full TimeOverview

　　Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious.

　　We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories.

　　Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers.

　　At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

　　Position Summary

　　This role provides support to the Quality department in the area(s) of quality, compliance and/or regulatory affairs. This role supports the overall quality program and serves as a liaison between the Quality team and other service lines of Versiti.  He/she/they partners with service lines to provide quality input on projects and everyday tasks.

　　Responsibilities

　　Core Quality Assurance Specialist Responsibilities* Supports Supervisor/Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards.* Identify and develop quality system improvements.* May integrate continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities.* May support internal/external assessments as assigned and facilitates optimal communication between the department and the inspector/assessors.* Prepares charts, tables, etc. to analyze quality metrics.  May communicate results and actions of quality metrics.* May review, approve and/or execute validation plans, corrective action plans associated with events, and other required documents for compliance as required.* Supports operations with review of proposed changes in methods, manufacturing, or instrumentation.* May support with the development, compilation, and submission of regulatory submissions as required.* Review, analyze, approve, and monitor events logged in event management system, including adequacy of investigation, quality of documentation, and appropriateness of corrective and preventative actions.* May support Manager with the review of events to assess impact to products/test results.* Acts a resource for regulatory and quality matters.

　　Specific Quality Assurance Specialist Responsibilities* Identify emerging events in the applicable service line(s) and assess product, donor, patient, and/or customer impact and risk.* Conduct problem surveillance (event reports, audit deficiencies, customer complaints, supplier recalls, etc.) and work with customers to effectively resolve problems.* Perform review of nonconforming products. Participate in decisions to determine product suitability for use, distribution, or recall.* Support organizational projects from a quality perspective and complete assigned tasks in a timely manner.* Ensure applicable service lines comply with the requirements of the quality management system, as applicable.* Serve as back up support to other Quality Assurance Specialists.* Actively participate in training, continuous improvement activities and Lean initiatives.* Perform other duties as assign