Assists the Manager of Quality Management to monitor and maintain the accreditation and credibility of the clinical laboratories based on industry standards. Provides Quality Assurance oversite to laboratories to ensure processes are conducted in accordance with guidelines and regulations. Monitors balanced scorecard metrics.
Manages document revisions, including authoring and document control activities. Creates study-specific project files and maintain all necessary documentation.
Schedules and conducts critical phase inspections and facility inspections for compliance with internal SOPs, study protocols, and federal regulations. Prepares written reports of inspections and audits for National Jewish management, principal investigator, and study director.
Works closely with the laboratory to ensure timelines, due dates, and respective collaboration occurs to meet client deliverables.
Collects data and reports audit results for compliance with internal SOPs, study protocols, and federal regulations. Maintains written records for all inspections and audits done for each study and/or laboratory.
Identifies and implements laboratory quality programs. Collaborates with leadership team on ways to improve laboratory efficiencies and facilitate performance improvement activities within ADx.
Supports laboratories through development and maintenance of a quality purposeful presence program.
Participates in preparation for inspections where required including revision of laboratory manuals and procedures. Identifies areas of risk in accordance with regulatory guidelines.
Perform quality audits. Author audit plan, document findings, review responses, and ensure that corrective action is implemented when non-conformances are found. Participates in client visits and any regulatory inspections.
Maintains knowledge of GLP regulations, CAP/CLIA regulations, and other applicable regulatory bodies. Responsible for GLP archiving, including transferring files to client as per procedure.
Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health.
Adaptability: Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
Creativity and Innovation: Applies creative problem-solving skills to develop solutions to problems; recognizes and demonstrates the value in taking “smart” risks and learning from mistakes; develops multiple alternatives and understands the feasibility of each; effectively shares and implements his/her ideas. Generates innovative solutions in work situations; tries different and novel ways to deal with work problems and opportunities.
Customer Focus: Ensuring that the customer perspective is a driving force behind business decisions and activities; crafting and implementing service practices that meet customers’ and own organization’s needs.
Decision Making: Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
Drive for Results: Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement.
Informing and Communicating: Clearly conveying information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
Peer Relationships: Interacts with others in a constructive, positive, and respectful manner, regardless of individual differences. Assists team members or co-workers in achieving personal goals and completing assignments.
Perseverance/Resourcefulness: Works to apply new approaches to existing challenges when delegated; is open-minded and will find new solutions when obvious problem or gap exists; validates accuracy of information collected; uses internal knowledge bases or best practices.
Continuous Learning and Development: Actively identifying new areas for learning; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skill to enhance their contribution to the organization.
Supervisory or Managerial Responsibility
Be available to work as scheduled and report to work on time.
Be willing to accept supervision and work well with others.
Be well groomed, appropriately for your role and wear ID Badge visibly.
Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.
Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.
Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.
Wears appropriate PPE as outlined by the infection control policies and procedures.
Demonstrates compliance with all state, federal and all other regulatory agency requirements.
Education: Bachelors degree required.
Work Experience: A minimum of six years working in a Quality Program required, clinical laboratory experience preferred. Experience in participating in preparing for regulatory inspection and accreditation programs is preferred.
Special Training, Certification or Licensure: Certified in quality management and regulatory compliance preferred.
About National Jewish Health
National Jewish Health is a non-profit, non-sectarian institution and is a longstanding cornerstone in the Denver healthcare community. National Jewish Health seeks to attract the best-qualified candidates who support the mission, vision and values of the Institution and those who respect and promote excellence through diversity. We are committed to providing equal employment opportunities (EEO) to all employees and applicants without regard to race, color, creed, religion, sex, age, national origin, citizenship, sexual orientation, gender identity and expression, physical or mental disability, marital, familial or parental status, genetic information, military status, veteran status or any other legally protected classification. We are a tobacco and fragrance free environment.