Regulatory & Cmplnce HC Spec 4 - Chao Cancer Cntr-Cell T Lab - FT Days

Updated: Jan 25, 2024
Location: Anaheim
Job Type:
Department: Chao Cancer Cntr-Cell T Lab

Job Description:

UC Title: REGL AND CMPLNC HC SPEC 4

Position Number: 41008004

Reports to: Ambulatory Care Patient Mgr 1

Working Title: Regulatory & Cmplnce HC Spec 4

Cost Center: Chao Cancer Cntr-Cell T Lab (427714)

Bargaining Unit: No Bargaining Unit

FLSA: Exempt

Date Created: 7/06/2023

Job Code: 006531

Hours: 40

Shift: Not Applicable

FTE: 1

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

In addition to the salary range listed below, 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 (https://www.hr.uci.edu/partnership/totalrewards/compensation.php ) and

Benefits (https://careersucirvine.ttcportals.com/pages/benefits ). 

Salary Range:

Annual Rate  Minimum  $103,100.00                       Midpoint            $157,200.00                       Maximum            $211,300.00

Required Qualifications:

Ability to maintain a work pace appropriate to the workload

Must demonstrate customer service skills appropriate to the job

Excellent written and verbal communication skills in English

Must possess the skill, knowledge and ability essential to the successful performance of assigned duties

Ability to design, administer and critically evaluate policies, procedures and processes against regulatory requirements

Advanced knowledge and experience/expertise in related field

Bachelor’s degree or higher in Biology or related field

Extensive experience with instrument troubleshooting, repair, testing and verification of system integrity.

Proficient with Microsoft Office applications

Five years of experience in Cell Therapy / Microbiology / Blood Bank/Immunohematology 

Good working knowledge of applicable laws, regulatory standards and policies for :FDA, FACT, GMP/GLP, , AABB, CADPH.

Licenses and Certifications:

Licenses and Certifications:

Clinical Laboratory Scientist Or 10 years comparable technical experience in a FACT or AABB cell processing laboratory.  

Preferred Qualifications: 

Preferred Qualifications: 

Master’s degree or certified Quality Manager

Clinical Laboratory Scientist with Quality Assurance experience

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 advancing inclusive excellence. 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 [email protected] or at (949) 824-0500, Monday – Friday from 8:30 a.m. – 5:00 p.m.

Share: mail +1 on Google Tweet Share on Facebook Share on LinkedIn

Apply for this Job