The Department of Laboratory Medicine and Pathology serves as a regional resource for clinical laboratory services required for patient care, research and educational programs in laboratory medicine and pathology. The department now employs 900 people who work at the award-winning University of Washington Medical Center (ranked among the top medical centers in the United States as rated by U.S. News & World Report), Harborview Medical Center (the region's only Level I Trauma center, known for innovations and excellence in trauma care and its centers of emphasis: Trauma, Burn, Neurosciences, AIDS/STD CARER, and mentally- and medically- vulnerable populations.), and many other clinical and research facilities in the area. The University of Washington (UW) is proud to be one of the nation’s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement and natural beauty.
Our Laboratory Medicine and Pathology department has an outstanding opportunity for a Full-time, (100%) Quality Assurance Manager.
This position will develop and manage the Quality Management System (QMS) that will ensure quality and efficiency of laboratory tests, products, and services for both patient-testing and clinical trial environment. This infrastructure is vital and a critical need to support our ability to perform phase 3 clinical trial testing, such as the COVID vaccine trials. This position will serve as the QA Manager as required by BioPharma contracts. This position will be responsible for the implementation, operation, and auditing of the QMS. This position will ensure the laboratories compliance with FDA and EU regulations; along with GCP (Good Clinical Practice), GLP (Good Laboratory Practices) and GDP (Good Documentation Practices) policies. This position will work with designated staff to ensure contractual requirements are met. This position will be the lab's representative for audits and inspections by FDA and Biopharma companies and will address and implement corrections to any deficiencies received. This position is independent of the clinical trial testing activities.
Minimum Requirements: Bachelor’s Degree in Medical Laboratory Science or related field AND 4-5 years laboratory experience.
Proficiency with WORD and EXCEL
Self-motivated and directed
Detail oriented and highly organized
Must be able to communicate clearly both written and verbal
Medical Laboratory Scientist with current ASCP certification
In-depth understanding of quality management concepts and regulatory/accreditation requirements.
Experience with laboratory Quality Management programs, particularly QA/QC procedures as related to CAP, CLIA, FDA and other regulatory bodies
Experience with auditing processes
Master's degree in a relevant field is preferred. Prior experience as a quality specialist is preferred. Knowledge of FDA regulations, including a minimum of two years experience working with GMP and/or GTP requirements.
This position provides opportunities to work in a fast-paced work environment. As an employee you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please view this page.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.