Quality Management Coordinator - Clinical Molecular Diagnostic Laboratory

Employer
City of Hope
Location
Duarte, California
Salary
Competitive
Closing date
May 28, 2022

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Discipline
Life Sciences, Molecular Biology
Position Type
Full Time
Organization Type
Healthcare/Hospital

Job Details

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.

Position Summary

Working as authorized by the Laboratory Director under Clinical Laboratory Improvement Amendments of 1988, CFR Section 493.1445(a). Under the direction of the Laboratory Supervisor, is responsible to monitor the quality management programs for technical and scientific standards, prepares quality assurance reports on monthly and quarterly basis, or immediately when obvious deviations from acceptable standards occur, monitors quality improvement and established thresholds for quality assurance indicators for laboratory adherence and compliance of policies set by City of Hope, governmental and non-governmental regulating agencies, oversees equipment issues, laboratory physical maintenance and repair issues, proper hazardous waste disposal, provides mentoring and technical guidance of staff, ensures the laboratory maintains continuous inspection readiness, as well as coordinating the CA-approved Clinical Genetic Molecular Biologist Scientist (CGMBS) training program. Responsibilities include oversight for the overall efficient operation of the laboratory, assists in the development of budgets for capital equipment purchases, monitors quality indicators by pre-reviewing completed studies for accuracy of analysis, appropriate clinical testing options, follow up requirements for additional testing, and competency assessments for staff. Maintains personal/professional development to ensure effective job performance to complete organizational goals.

Specific responsibilities include overseeing all aspects of the laboratory Quality Management program, monitoring quality assurance indicators, generating quality reports for QA, QI, and QC, ensuring compliance with safe laboratory practices, safety, and regulatory compliance (CAP, HIPAA, etc.) to ensure a safe workplace, providing technical guidance, coordinating capital equipment purchases, replacement and maintenance schedules, and preliminary reviewing and resulting of clinical cases. In addition, overseeing and actively participating as an instructor for CA-approved Clinical Genetic Molecular Biologist Scientist (CGMBS) Training Program.

Key Responsibilities include:
  • Monitors quality assurance indicators, laboratory monitoring logs, equipment inventories, performance improvement projects, capital equipment purchasing, safety monitoring, physical laboratory monitoring of equipment and air temperature, and chemical waste disposal.
  • Generates QA, QC, QM and PI reports on monthly or quarterly basis. Aids in validation studies, as needed.
  • Performs preliminary review of molecular results (all samples) after the technologist completes the testing. Evaluates processing/completeness per specimen type.
  • Maintains knowledge of technical procedures, regulatory compliance issues and information systems and demonstrates expertise and competency required to monitor effectiveness of all procedures within areas of responsibility.
  • Maintains knowledge of newly developed CAP and ACMG guidelines by annual review, presenting the new standards to staff and updating new procedures as needed.
  • Annually reviews Policy and Procedure manual; daily, monthly, and quarterly reviews of QA, QC and QI records to recognize factors that affect measurements and results and take appropriate corrective action, if needed.
  • Participates in development and documentation of new test assays with appropriate validation statistics, as defined by CAP and ACMG. Evaluates new technologies and determine utility and cost effectiveness to meet organization goals.
  • Manages all aspects of proficiency examinations per College of American Pathology (CAP) guidelines. Maintains constant state of CAP readiness for unannounced inspections.
  • Maintains a safe and efficient working environment.
  • Supports development of future workforce through skills training and mentoring.
  • Coordinates the CA-approved clinical molecular biologist scientist training program under the direction of the Laboratory Supervisor, maintains trainee paperwork, and completes all forms and evaluations of trainees. Assigns individual projects to trainees and provides timely review of projects during training.
  • Creates course syllabus and lecture schedules. Provides lectures to trainees, in conjunction with manager, supervisors and directors.
  • Provides technical training on procedures.
  • Monitors laboratory equipment and oversees routine mainenance to ensure accuracy and safety of all equipment used in laboratory.
  • Monitors equipment logs and ensures preventative maintainance and inspections are on schedule.
  • Obtains vendor quotes for new equipment, PM agreements and followup on timely deliveries of equipment.
  • Ensures that all CMDL reagents used for clinical testing demonstrate acceptable performance before patient tests results are released, and that all reagents are properly labelled, handled, stored, and used in compliance with applicable regulations and requirements.
  • Helps to select, train, and mentor laboratory staff including the Clinical Genetic Molecular Biolofist Scientist (CGMBS) trainees. Works with supervisors to ensure timely documentation of new hire training and competency assessment.
  • Shares information and provides assistance to team members as needed to meet objectives and assure the success of team efforts. Promotes laboratory efficiency, workplace safety, and talent development of staff.
  • Provides mentoring and technical guidance to laboratory staff.


Basic education, experience and skills required for consideration:
  • Bachelor's degree in a Chemical, Physical, Biological, Clinical Laboratory Science or Medical Technology
  • Minimum of five years as a licensed technologist in molecular diagnostic laboratory

Required Certification/Licensure:
  • CGMBS (Clinical Genetic Molecular Biologist Scientist) or
  • Clinical Laboratory Scientist (California License)

Additional Information:
  • As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.

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. #LI-AH

Company

City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research.  City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

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