The New Day Diagnostics Clinical Laboratory Manager is responsible for the on-site administrative, technical, and operational oversight of the clinical laboratory. The Clinical Laboratory Manager directs the work of the laboratory to maintain quality technical and regulatory standards while maximizing resource utilization within budgetary constraints. They coordinate with the Laboratory Medical Director to ensure regulatory compliance and effective laboratory operations. In addition, the Clinical Laboratory Manager fulfills the duty of CAP/CLIA-defined and state-designated General Laboratory Supervisor, and they may serve as Technical Supervisor if qualifications are met for the appropriate testing subspecialty/section.

2 Duties and responsibilities Departmental Operations and Testing Oversight· Perform administrative duties, including staff management, training, competency assessment, and development. Coordinate regular proficiency testing under the direction of the designated Technical Supervisor for the laboratory section (department).· Supervise laboratory employees, organize workflow, and prioritize assignments to optimize testing quality and operational efficiency. · Provide day-to-day supervision of clinical laboratory testing performed by qualified testing personnel. Be accessible as needed for on-site, telephone, or electronic consultation. Maintain proficiency/competency in technical operations and participate in regular testing duties as necessary. · Monitor test performance, oversee resolution of technical problems in accordance with policies and procedures established by the Laboratory Director or Technical Supervisor, and ensure remedial actions are taken when test systems deviate from the laboratory’s established performance specifications.· Collaborate with other laboratory leadership to provide clear direction for efficient laboratory operations, and coordinate with sales and projects teams to contribute to the scoping and organization of new projects related to clinical laboratory testing.· Participate in the selection and qualification of reference laboratories and conduct ongoing monitoring of testing outcomes and the relationship with reference laboratories.· Devise appropriate and cost-effective measures to improve laboratory operations.· Carry out the duties of the CLIA-defined, state-licensed General Laboratory Supervisor as outlined in 42 CFR 493.1463 and Tennessee Code 1200-06-01 and in CAP GEN.53600, including duties delegated in writing by the Laboratory Medical Director as authorized in the aforementioned CLIA and CAP regulations. Quality Assurance, Compliance and Laboratory Maintenance· Under the direction of the Laboratory Medical Director, monitor QA/QI issues and overall department performance and ensure compliance with regulatory agencies, state licensure requirements, Good Laboratory Practices (GLPs), and applicable company policies, procedures, and quality initiatives.· Research, recommend, and assist in the onboarding of new equipment and test methodologies for the department in coordination with the Technical Supervisor.· Encourage and contribute to continuous quality improvement in the laboratory by overseeing development and implementation of standards and processes to improve service and quality.· Write, review, and revise technical documents for the clinical laboratory to comply with applicable regulations and to align with overarching and related QMS documents and processes.· Ensure execution and documentation of maintenance and monitoring of the lab, equipment, LIS, and inventory. · Act as clinical laboratory liaison to the Laboratory Medical Director and to state, federal, and accreditation agencies.Other Duties

• Contribute technical and logistical direction and expertise to New Day R&D projects requiring laboratory support and evaluation. Assist with R&D testing and troubleshooting as needed.
• Maintain appropriate state licensure and board certification and required continuing education

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3 Qualifications

· Current Medical Laboratory Supervisor license issued by the State of Tennessee Department of Health

· Doctoral, master’s or bachelor’s degree in clinical laboratory science or in a chemical, physical, or biological science from an accredited institution, with at least two years of comprehensive clinical laboratory training and/or experience in high complexity testing (as defined by 42CFR493).

· Must meet requirements of the General Laboratory Supervisor (or Technical Supervisor, if fulfilling the role) as defined by CAP and CLIA regulations

• 3-5 years clinical laboratory supervisory/management experience
• National board (i.e., ASCP) certification (i.e., DLM, MLS, etc.)
• Familiarity with regulated disciplines in a clinical laboratory setting
• Strong analytical skills with the ability to apply medical and technical knowledge to evaluate laboratory performance
• Ability to read and follow Standard Operating Procedures and to maintain complete and accurate records.
• Excellent interpersonal skills and communication skills including written, verbal and oral presentations.
• Attention to detail with good organizational and problem-solving skills.
• Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to Relocate:

• Knoxville, TN 37919: Relocate before starting work (Required)

Work Location: In person