Blood Donor Quality Manager

Company Name:
SCL Health System
St. Mary's Hospital is dedicated to meeting the healthcare needs of the residents of western Colorado and eastern Utah. An opportunity exists for a Blood Donor Quality Manager. The St. Mary's Regional Blood Center is a hospital-based program that collects over 14,000 units per year. Blood from St. Mary's Regional Blood Center helps St. Mary's trauma, surgical, and cancer patients as well as providing the blood needed at most of the region's smaller hospitals in western Colorado and eastern Utah.
A not-for-profit organization, St. Mary's Hospital was founded in 1896 by the Sisters of Charity of Leavenworth. Today, St. Mary's Hospital is the largest medical center between Denver and Salt Lake City, and boasts over 350 beds, approximately 2,000 staff and 300 active physicians.
To learn more about St. Mary's Hospital-Based Regional Blood Donor Center, visit http://www.stmarygj.com/blood-donor-center
Duties & Responsibilities
The Quality Manager is responsible for the effective implementation and management of the Donor Center Quality Program including document management, equipment qualification, process validation, coordinate internal and external audits, corrective and preventive action, process control and improvement, lot release, and management of non-conforming products. This position has authority to stop production, quarantine or take appropriate immediate action to ensure the safety of donors and patients, and the purity, potency and safety of all blood products.
Research and analyze changes in FDA Memoranda/Guidance Documents, AABB Standards and Association Bulletins, and any customer-specific requirements with potential impact on the Donor Center
Manage the deviation and CAPA program
Prepare and submit Biological Product Deviation Reports, annual reports, product licensure documents, and any other documents required or requested by FDA
Process donor deferral, lookback, donor and consignee notifications for Medical Director review
Review documents (procedures and process validation, computer validation, and equipment qualification plans) prior to execution and after completion for regulatory compliance
Perform lot release and resolve issues prior approval of labeling
Deliver cGMP training for all new staff members and thereafter as needed for all staff
Manage the Donor Center's documents and records
Prepare Quality Assurance SOPs, forms, and associated documents
Coordinate external assessments and inspections conducted by FDA, AABB, and other organizations with regulatory or accreditation authority; prepare responses and tracks corrective action efforts to ensure compliance
Conduct internal audits and prepare written reports of findings for executive management
Work with other members of Blood Center's Executive Management to establish and/or make changes to the quality system, ensure compliance with applicable regulations and requirements, and monitor performance
Education: Bachelor of Science degree with emphasis in biological science, immunohematology or related area required. Certification by American Society of Clinical Pathologists, Certified Quality Auditor and SBB certification preferred.
Experience: 3 Years or more experience in a regulatory environment, preferably a Blood Bank/Donor Center with knowledge/experience in compliance with FDA regulations and AABB accreditation requirements.
License/Certification/Registration: Certification by American Society of Clinical Pathologists, Certified Quality Auditor, SBB certification preferred.
Qualified candidates are encouraged to Apply Now for immediate consideration.
Relocation assistance is available along with access to our competitive benefits packages which include comprehensive selections of medical, dental, vision, life insurance, disability, retirement and more.
St. Mary's Hospital & Regional Medical Center is located in Grand Junction Colorado, a community that is welcoming and entrepreneurial. Grand Junction is a hub for education, retail, healthcare and energy development. The area boasts many outdoor recreational opportunities and a vibrant downtown with many entertainment options.
To learn more about St. Mary's Hospital & Regional Medical Center, please visit www.stmarygj.org

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