About City of Hope

City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913,City of Hopehas grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis fornumerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, andtreatment facilities in Atlanta, Chicago and Phoenix. City of Hope’s affiliated family of organizations includesTranslational Genomics Research InstituteandAccessHope^TM. For more information about City of Hope, follow us onFacebook,Twitter,YouTube,InstagramandLinkedIn.

City of Hope’s commitment to Diversity, Equity and Inclusion

We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds and perspectives; this is reflected in our work and represented in our people.

Position Summary

In conjunction with the Quality and Regulatory Affairs Manager, assists with the maintenance, support, and ongoing development of the Transfusion Medicine Quality Management System and performs quality/regulatory activities for the division. Serves as a resource for the division in assuring compliance with applicable Federal and State laws and regulations, and the requirements of related accrediting agencies. Works with other institutional departments on quality/regulatory activities related to Transfusion Medicine operations. Interacts with external regulatory/accrediting agencies as needed to maintain appropriate licensing/accreditation and reporting. Assists with the validation of Transfusion Medicine Information Systems (TMIS).

Key Responsibilities include:

• Provide support to division supervisors and managers in the development and maintenance of policies and procedures for quality activities such as equipment and process validations; compliance with new/revised regulatory/accrediting agency requirements; vendor qualification; control of documents and records; nonconforming event reporting and follow-up; and staff training and competency.
• Perform scheduled and ad hoc internal and external quality assessments, as assigned.
• Assist with the evaluation, testing, validation and implementation of new or revised information systems, including hardware and software installation.
• Interact with external regulatory/accrediting agencies as needed to maintain appropriate licensing/accreditation and reporting and assist in hosting inspections by external regulatory/accrediting agencies and/or contractors with Transfusion Medicine.
• Participate with division supervisors and managers in the development of policies, processes, and procedures for new or revised investigational protocols that require products or services from Transfusion Medicine.
• Serve as a back-up resource for administration of our TMIS, perform trouble shooting of Transfusion Medicine information systems, and take part in a rotating schedule of on-call duty for TMIS support.
• Perform change control procedures, testing, and validation of changes to the existing Transfusion Medicine information systems.
• Provide support to division supervisors and managers in ensuring that staff are educated in, and operations meets, the requirements of current good manufacturing practices (cCGMP), good laboratory practices (GLP), good tissue practices (cGTP) and good documentation practices (GDP) and revise training materials, etc. as applicable.
• Maintain records in conformance to division, institutional, and regulatory requirements; Facilitate annual continuing education webinars
• Perform tasks related to the monitoring and maintenance of Transfusion Medicine information systems.
• Performs other related duties as assigned or requested.

Basic education, experience and skills required for consideration:

• Minimum Education: Bachelor’s Degree
• Minimum Experience: 5+ years’ experience in Blood Banking

Required Certification/Licensure:

• Blood Bank (ASCP), Medical Laboratory Scientist (ASCP) or Specialist in Blood Bank SBB (ASCP)

Preferred education experience and skills:

• California Clinical Laboratory or Immunohematologist Scientist License

Additional Information: