Assists the Quality Director to monitor and maintain the accreditation and credibility of the clinical laboratories based on industry standards. Collaborates with laboratories and facilitates efforts of all laboratory departments to remain in constant compliance with all regulatory agency requirements. Monitors balanced scorecard metrics.
1. Assists to ensure 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. Monitors safety environment of laboratories through safety audits. Monitors adherence to CDC safety guidelines for BSL2 and BSL3 facilities.
3. Performs quality audits. Author audit plan, document findings, review responses, and ensure that corrective action is implemented when non-conformances are found. Led document revisions, including authoring and document control activities. Author laboratory wide quality performance monitoring reports, including development of laboratory wide quality dashboard.
4. Leads improvement activities and initiatives for laboratories and implement improvements via partnerships and collaborations.
5. Helps to ensure proficiency testing and event systems are actively maintained, trended, and reviewed for timely closure. Facilitate activities required for occurrence closure and proficiency review completion.
6. Maintains equipment monitoring systems, including accurate asset inventory, calibration timelines and maintenance.
7. Partner and collaborate with laboratory wide teams for laboratory wide quality improvements. Makes recommendations to improve laboratory quality and performs extra projects of increasing complexity and skill and completes projects as directed and approved by the director.
8. Implements continuous improvement programs to continually improve processes and programs, including electronic improvement programs. Supports laboratories through development and maintenance of a quality purposeful presence program.
9. Contributes to Quality meetings with required participation by all areas having an impact on pre-analytical, analytical and post-analytical phases of testing.
10. Participates in preparation for inspections where required including revision of laboratory manuals and procedures. Identifies areas of risk in accordance with regulatory guidelines.
1. Attends continuing education programs sponsored by National Jewish and/or professional society programs. Obtains at least 12 approved CEU credits per year including not limited to the following: webinars, lunch and learn seminars, seminars, etc.
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. Coaching and Teaching Others: Providing timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Problem Solving: Uses issue identification, data relation and comparison, pattern recognition and information gathering to create analyses and make recommendations.
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.
Bachelors in a scientific discipline or closely related field required.
A minimum of eight years working in Quality 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