ResponsibilitiesAs the Senior Clinical Laboratory Specialist for Regulatory Affairs, you will provide leadership and technical expertise for the quality and compliance program within the Department of Pathology and Laboratory Medicine, primarily for Transfusion Medicine, focusing on Blood Donation and Component Manufacturing. Success in this vital role will require in-depth knowledge of the relevant regulatory and accrediting agency requirements for blood banks, including CLIA, Department of Public Health, FDA, CAP and AABB. You will maintain quality systems throughout our multidisciplinary laboratory environment while ensuring adherence to all regulations, laws, guidelines, and standards of the licensing, accrediting, government and credentialing agencies. You will also:
•Review quality data, proficiency testing activities and validation plans •Perform assessments/audits •Develop new policies, processes and procedures •Provide technical review for both the laboratory and UCLA Health •Review nonconforming events to identify systematic problems •Review data trends for risk management/process improvement •Oversee document control and record retention practices and conduct trainings
Salary Range: $57.22 - $73.68/hour
QualificationsWe’re seeking a detail-oriented professional with a current CLS license, a Bachelor’s degree and:
•At least 2 years of experience in quality assurance and compliance related activities, to include training/lecturing •A minimum of four years of clinical laboratory scientist experience •Knowledge in deviation management and applying corrective action •Knowledge of project planning/implementation •Experience writing procedures and reports •Excellent presentation skills
UCLA is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.
At UCLA Health, you can help heal humankind, one patient at a time by improving health, alleviating suffering and delivering acts of kindness. As you do, you’ll achieve great things in your life and your career. We’re a world-class health organization with four hospitals consistently recognized among the nation’s very best as well as an internationally-renowned medical school, primary and specialty care clinics and much more. Within our dynamic, innovative and growing organization, you’ll find exceptional opportunities to make the most of your abilities in a supportive, empowering and inclusive environment. If you embrace our values of Integrity, Compassion, Respect, Teamwork, Excellence and Discovery we invite you to see all you can accomplish at UCLA Health.
AABB (Association for the Advancement of Blood & Biotherapies) is an international, not-for-profit organization representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. The Association works collaboratively
to advance the field through the development and delivery of standards, accreditation and education programs. AABB is dedicated to its mission of improving lives by making transfusion medicine and biotherapies safe, available and effective worldwide.