Regulatory & Cmplnce HC Spec 4 - Cancer Center- Stem Cell Clinc - FT Days

UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system based in Orange County. UCI Health is comprised of its main campus, UCI Medical Center, a 459-bed, acute care hospital in in Orange, Calif., four hospitals and affiliated physicians of the UCI Health Community Network in Orange and Los Angeles counties and ambulatory care centers across the region. Listed among America's Best Hospitals by U.S. News & World Report for 23 consecutive years, UCI Medical Center provides tertiary and quaternary care and is home to Orange County's only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center, gold level 1 geriatric emergency department and regional burn center. UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County.

To learn more about UCI Health, visit www.ucihealth.org.

Position Summary:

Incumbent serves as a subject matter expert in hematopoietic stem cell transplant (HSCT) and cellular therapy regulatory affairs and quality assurance, providing consultative services for department leaders. Uses specialized knowledge for reports, external inspections, responding to inspection deficiencies and setting policy for quality assurance and compliance activities. This position performs duties of an information system super user for software and databases associated exclusively with the Cellular Therapy Laboratory. Responsible for development, maintenance and enforcement of the quality plan. Ensures the Cellular Therapy Laboratory is in compliance with the Foundation for Accreditation of Cellular Therapy (FACT) standards, Association for the Advancement of Blood and Biotherapies (AABB) standards, and other associated regulatory agencies.

Total Compensation

We offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.

Required Qualifications:

• Must possess the skill, knowledge and ability essential to the successful performance of assigned duties
• Must demonstrate customer service skills appropriate to the job
• Knowledge of Good Laboratory Practices (FDA, CAP, TJC, AABB, CADPH).
• Five years of experience in toxicology, chemistry and ...sciences.
• Familiar with Microsoft Office applications
• Extensive experience with instrument troubleshooting, repair, testing and verification of system integrity.
• Excellent written and verbal communication skills in English
• Bachelor's degree or higher in Biology or related field
• Advanced knowledge and experience/expertise in related field
• Ability to maintain a work pace appropriate to the workload
• Ability to design, administer and critically evaluate policies, procedures and processes against regulatory requirements

Preferred Qualifications:

• Master's degree or certified Quality Manager
• Clinical Laboratory Scientist with Quality Assurance experience
• BSN level or higher licensed Registered Nurse with Quality Assurance experience

Licenses and Certifications:

Conditions of Employment:

The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:

• Background Check and Live Scan
• Legal Right to Work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.

• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Details of each policy may be reviewed by visiting the following page: https://hr.uci.edu/new-hire/conditions-of-employment.php

Closing Statement:

The University of California, Irvine 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, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.

We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact UCI's Employee Experience Center (EEC) at eec@uci.edu or at (949) 824-0500, Monday - Friday from 8:30 a.m. - 5:00 p.m.