Cellular Therapy QA Specialist

  • UCLA Health
  • Los Angeles, CA, USA
  • Jun 23, 2022
Full Time Therapy

Job Description

Responsibilities

Provide guidance to maintain a quality and compliance program within the Bone Marrow Stem Cell Lab, Hemapheresis Unit and Hematologic Malignancies/Stem Cell Transplantation (HM/SCT) Adult and Pediatric Clinical Program.  Maintain Quality System Essentials throughout an active Cellular Therapy program, Hemapheresis Unit and Stem Cell lab operation.  Ensure compliance with all regulations, guidelines, and standards of the licensing accrediting credentialing and regulatory agencies with particular focus on FDA guidelines for Current Good Tissue Practices, HCT/Ps and FACT. Ensure adherence to UCLA internal policies for safety and corporate compliance.  Serve as QA and regulatory resource department wide within the framework of a QA and compliance unit.  Activities of a quality program include: Development, maintenance, review and approval of SOPs, training programs, competency assessment programs validation and revalidation plans and results record keeping and document control systems, corrective and preventive action plans, proficiency testing programs.  Performs audits of operational functions.  Review and evaluate reports of occurrences and adverse events.  Collection and analysis of quality metrics. Application of process improvement tools and techniques.

Qualifications

  • Bachelor’s Degree or Master’s Degree in healthcare highly preferred.
  • Interpersonal skills to establish and maintain effective working relationships with medical teams, staff and other colleagues.
  • Excellent verbal and written communication skills.
  • Ability to communicate effectively with persons of various cultural and educational backgrounds.
  • Excellent organizational skills, proficiency in meeting deadlines, ability to work independently, manage numerous concurrent tasks in a high stress environment, deal with change and prioritize workload.
  • Familiarity with Medical Center and University department functions and policy and procedures.
  • Knowledge and experience with data systems with the Medical Center.
  • Knowledge of transplantation and issues involving organ procurement.
  • Experience in project planning and monitoring with knowledge of process improvement and quality management.
  • Supervisory and employee management skills.
  • General knowledge in the use of computerized clinical information systems databases.
  • Ability to analyze information to define the problems/objective, identify relevant factors, patterns or relationships; formulate objective conclusions and recognize alternatives and their implications.

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.

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Employment Type (feed only)

FULL TIME