Senior CLS Information Systems & Quality Management Specialist

City of Hope

Irvine, CA

Job posting number: #7092965 (Ref:10014175)

Posted: January 27, 2022

Application Deadline: Open Until Filled

Job Description

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 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 leading cancer centers that develops and institutes standards of care for cancer treatment.

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 Director and Director of Clinical Laboratories, 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.  Responsibilities include oversight for the planning, assisting in the building of specification documents, and testing for Epic Beaker LIS implementation. Support, maintenance, and testing of clinical laboratory information systems (LIS) including databases, interfaces, and operational aspects of the laboratory.

Key Responsibilities include:

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. 

Technical and scientific oversight

  • Monitors quality assurance indicators, laboratory monitoring logs, equipment  inventories, performance improvement projects, 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.
  • 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. 

Laboratory and Quality Management

  • Maintains knowledge of newly developed CAP 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.  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.

Laboratory Information Systems

  • Participates in the planning, design, build, and testing for Epic Beaker LIS implementation. Support, maintenance, and testing of clinical laboratory information systems (LIS) including databases, interfaces, and operational aspects of the laboratory.
  • Performs advanced-level design, build, testing, validation, and implementation assignments/projects. Based on deep knowledge of laboratory application and operational requirements, can translate complex requirements/concepts into system specifications and configuration requirements.
  • Attends and represents laboratory on various Epic-related committees. Assists Epic Beaker analyst in developing project plans and details. Manage and coordinate the more sophisticated configuration and build assignments/projects in collaboration with others.
  • Ensures the research and documentation of project requirements, test plans, testing, and validation is completed.

Personnel management

  • Interviews and helps to select, train, and mentor laboratory staff.  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:

Minimum Education: Bachelor's Degree

Minimum Experience: Minimum 5 years as a certified or licensed Clinica Laboratory Scientist

Required Certification/Licensure: N/A

Additional Information:

To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021.  Compliance is a condition of employment.   

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.

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