HLA Laboratory Quality Manager - Hybrid
Job posting number: #7112231 (Ref:10018818)
Posted: September 30, 2022
Application Deadline: Open Until Filled
About City of Hope
City of Hope is an independent biomedical research and treatment organization for cancer, diabetes and other life-threatening diseases.
Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a subsidiary launched in 2019 serves employers and their health care partners by providing access to City of Hope’s specialized cancer expertise.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
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.
Under the direction of the HLA Laboratory Director, the HLA Quality Manager will be responsible for planning and implementing quality management, compliance, regulatory affairs, and safety of the HLA Laboratory departments. The HLA Quality Manager will serve as a resource for the department in assuring compliance with all Federal and State laws and regulations, and the requirements of related accrediting agencies. Work with other institutional departments on quality/regulatory activities related to the HLA Laboratory operations. Interact with external regulatory/accrediting agencies as needed to maintain appropriate licensing/accreditation and reporting. Staff training and competency will be cosigned by the licensed Lab Manager while licensing is being obtained.
Key Responsibilities include:
- Work with HLA Laboratory Director and supervisor in the administration, maintenance, and on-going development of the department’s quality management system and performance of quality/regulatory activities.
- Develop, maintain, and execute policies, processes, and procedures for quality activities including:
- Equipment and process validations
- Compliance with new/revised regulatory/accrediting agency requirements
- Error/accident reporting, investigating, and follow up
- Control of policies, procedures, and forms
- Ensuring completion of quality control documentation
- Staff training and competency
- Reviewing continuing education records
- Maintaining personnel files
- Manager internal and external quality assessments as assigned and assist in hosting inspections by external regulatory agencies and/or contractors with HLA Laboratory
- Responsible for the development of policies, processes, and procedures for new and/or revised investigational protocols that require products or services from HLA Laboratory.
- Provide support to division supervisors and managers in ensuring that staff are educated, and operations meets the requirements of current accredited agencies.
- Serve as the department Safety Officer. Prepares monthly Quality meetings and defines variables for monitoring frequently.
- Perform inspections for outside HLA labs.
- Responsible for performing internal inspections periodically, documents findings and plans, and executes deficiency responses
- Oversees document management software and keeps documentation for periodic review. Maintain records in conformance to department, institutional, and regulatory requirements.
- Assist the HLA Laboratory supervisor with monitoring quality metrics and preparing the QA Monitoring Report.
- Performs other related duties as assigned or requested.
Basic education, experience, and skills required for consideration:
- Bachelor’s Degree
- Five to seven years of experience including quality management and laboratory compliance.
- Regulatory affairs experience with: CAP, ASHI, CLIA, FACT, NMDP, CDPH (California Department of Public Health)
- Exceptional technical knowledge of all aspects of the laboratory operations
- Ability to develop effective professional relationships with all levels of staff and management
- Strong written and verbal communication skills.
- Strong knowledge of computer hardware/software programs and laboratory information systems
- Demonstrate respect for patient privacy
- Ability to communicate highly technical information in common vernacular
- California license as a Clinical Laboratory Scientist or Histocompatibility license; or will obtain either of the California licenses within 9 months from date of hire or transfer.
Preferred education, experience, and skills:
- CHS (ACHI – American College of Histocompatibility and Immunogenetics)
- HLA or transplant - related laboratory experience.
- Advanced Degree - i.e., MBA, MPH etc.
As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
- Shift: Day
- Job Status: Full-Time
- Relocation assistance may apply.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.