Assists the Manager of Quality Management to monitor and maintain the accreditation and credibility of the clinical laboratories based on industry standards. Serves as a point of contact to laboratories for Quality related issues, ensuring compliance with all regulatory agency requirements. Monitors the Oncology Satellite laboratories to ensure compliance with regulations.
1. Assists in ensuring laboratory compliance by serving the laboratories as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) regulations, CAP accreditation standards, and various state accreditation standards, CDC guidelines and permits, licenses for all labs, and audit to assure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations.
2. Performs quality audits. Documents findings, reviews responses, and ensures that corrective action is implemented when non-conformances are found.
3. Participates in improvement activities and initiatives for laboratories and implement improvements via partnerships and collaborations. Facilitates quality improvement teams to achieve set objectives and work towards continuous improvement.
4. Provides input into validation plans and validation activities for new methods. Reviews validation/verification documents.
5. Monitors processes for quality control of analytic methods and verifies that all tests are monitored through an appropriate proficiency-testing program as required.
6. Facilitates prompt and complete reporting of occurrences and/or serious quality issues and assure effective corrective action. Facilitates activities required for occurrence closure.
7. Assists with document authoring, revisions, and document control activities.
8. Helps to ensure that the Change Control process is followed including the facilitation of meetings.
9. First point of contact with transitions to improved systematic processes for quality management systems. Supports laboratories through the quality purposeful presence program.
10. Assists manager in developing appropriate performance and quality reports.
11. Monitors the Oncology satellite laboratory sites with regular site visits to ensure compliance with regulations.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Impact and Influence: Using appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one’s own behavior to accommodate tasks, situations, and individuals involved. Taking advantage of opportunities to make a difference and have an impact. When used well, the intended outcome of this competency is the creation of goodwill, trust, and respect while motivating people to want to follow you even when they don’t have to.
7. 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.
8. 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:
1. Be available to work as scheduled and report to work on time.
2. Be willing to accept supervision and work well with others.
3. Be well groomed, appropriately for your role and wear ID Badge visibly.
4. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.
5. Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.
6. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.
7. Wears appropriate PPE as outlined by the infection control policies and procedures.
8. Demonstrates compliance with all state, federal and all other regulatory agency requirements.
Bachelor’s degree required.
A minimum of four years working in 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:
Valid Driver’s License required. Certified in quality management and regulatory compliance preferred