The Quality Management Coordinator position involves Quality Assurance and Quality Control activities. The employee will be responsible for compliance with applicable regulatory requirements; conducts audits, analyzes data and reviews documentation. Assist in the development and implementation of quality assurance procedures, tracks quality metrics to recognize and identify areas where policies and procedures need to be changed or developed. Participates in defining quality issues and determining approaches and methodology for addressing these issues. Additionally, will assist in the development of Quality Systems.
Develop, update, and oversee the Quality Management Program for the Nebraska Medicine Apheresis Department. Work closely with the Apheresis Medical Directors, Managers, and Nursing Supervisor. Assure program and staff compliance with accrediting requirements (FACT, AABB, Joint Commission, etc.) and organizational standards, policies and procedures. Conduct audits, analyze data and review apheresis documentation. Assists in the implementation of quality assurance procedures, tracks quality metrics to recognize and identify areas where policies and procedures need to be changes or developed.
Minimum of 3 years experience in quality assurance activities in a regulated industry required.
High School education or equivalent required.
Bachelor’s Degree in a scientifc field or completion of a certified Medical Technoloigst ( MT/ASCP) or Clinical Lab Scientist ( CLS(NCA) or equivalent combination of education and experience ( One year of education equals one year of experience)required.
Effective oral and written communication skills required
Experience with computer workstation and Microsoft Office: Word, Excel, and PowerPoint required.
Experience within any of the following Quality Systems: Audits, Change Management, Document & Record Control, Deviation Management, CAPA, and/or Material Management required.
Prior quality assurance experience in laboratory, pharmaceutical, clinical medicine, blood bank, tissue bank, or medical device applicantions preferred.
Experience with FDA, AABB, FACT and or other regulatory/accrediting agencies preferred.
Experience in training programs and equipment qualification preferred.
Skills in Microsoft Access and Outlook preferred.
Familiarity with current Good Tissue Practices (CGTP) and Current Manufacturing Proactice (CGMP) calssified production areas preferred.
Operational experience with laboratory equipment, instruments and regents preferred.
Internal Number: 39496
About Nebraska Medicine
Nebraska Medicine is the most esteemed academic health system in the region, consisting of 809 licensed beds at its two hospitals, more than 1,000 physicians and 40 specialty and primary care clinics in Omaha and surrounding areas.
Nebraska Medicine and its research and education partner, the University of Nebraska Medical Center (UNMC), share the same mission: to lead the world in transforming lives to create a healthy future for all individuals and communities through premier educational programs, innovative research and extraordinary patient care.
Nebraska Medicine traces its roots back to 1869 with the founding of Omaha’s first hospital. In the decades since, it has built an international reputation for breakthroughs in cancer care, organ transplantation and treatment of infectious diseases.
In 2016 and 2017, Nebraska Medicine earned the Bernard A. Birnbaum, MD Quality Leadership Award from Vizient, Inc., which recognized the Nebraska Medical Center in the top 12 out of more than 100 quality academic health systems in the United States. The award was for demonstrating superior quality and safety performance. For five straight years, Nebraska Medicine has also been named to Becker’s Hospital Review’s list of 100 Great Hospitals in America.