Clinical Laboratory Manager
4 weeks ago
The Role
Under the general supervision of the Clinical Laboratory Director, provides assistance in planning, organizing and preparing laboratory in support of clinical testing activities at Belay Diagnostics laboratory ((BDL). Primary responsibilities include managing laboratory personnel, overseeing clinical/production testing and troubleshooting issues when they arise. This position requires a high degree of knowledge and technical abilities in molecular technologies as would be performed in a clinical genetic testing laboratory. The position also requires administrative duties such as daily/weekly laboratory updates, management of laboratory inventory, review of quality metrics across different test systems, writing of standard operating procedures, support compliance requirements and other duties deemed necessary by the Clinical Laboratory Director.
Key responsibilities
Laboratory Operations
- Efficient and quality execution of sample accessioning, processing, and data generation for the BDL as necessary. This includes working with the Director(s) to maintain all documentation required for operation under CLIA/CAP certification, including review and writing of SOPs as necessary and use of sample tracking systems in accordance with standard operating procedures.
- Supervise the operations of the laboratory technicians ensuring proper allocation of personnel and resources to ensure set turnaround times for clinical/research projects.
- Organize the laboratory workflow to ensure the laboratory technicians understand delegated duties to allow for adequate employee monitoring.
- Performs quality control of samples processed and data generated prior to sending to next steps and Ensure accurate and timely maintenance of operational metrics
- Maintains and updates associated process documentation, participates in continuous process improvements and ongoing training
- Maintenance of auxiliary and capital equipment and instrumentation in accordance with CAP/CLIA regulations.
- Provide weekly laboratory update reports to the clinical laboratory director to improve performance by systematically removing waste and reducing variation to streamline the laboratory processes. This includes creating weekly/monthly reports on laboratory critical values to assist in noticing trends for remediation.
- Supervise process control and QA/QC measures and ensure personnel follow prescribed SOP's and practices to ensure compliance with CLIA/CAP certification.
- Assist in the development and validation of new methodologies, including establishing novel workflows, evaluating new instrumentation and protocols as deemed necessary, including establishing and maintaining competency of staff in new assays.
- Maintain project and sample information, protocols, and experimental details through the Laboratory Information Management System (LIMS).
- Provide support to the Laboratory Director in implementation of QM program.
- Maintains high level of customer satisfaction through effective communication and problem solving. Implements effective customer service strategies.
Regulatory Compliance (Licensing, Accreditation, and Safety)
- Maintains working knowledge of laboratory regulations and accreditation requirements.
- Develops and monitors systems to ensure laboratory compliance with CLIA, OSHA (Occupational Safety and Health Administration), and CAP (College of American Pathologists) regulations, and BDL safety policies and procedures.
- Participates in internal audits and external assessments/inspections and takes corrective action to remedy deficiencies identified in audits and assessments.
Supervision and Leadership
- Ensures job descriptions and performance standards are complete and current for each position in the laboratory.
- Monitors and documents staff performance, sets goals in accordance with organizational priorities, and coaches staff to improve performance and conducts performance appraisals.
- Ensures compliance with employment laws and Belay Human Resources policies.
- Participates as an effective member of the BDL management team.
- Develops and maintains training plans for staff and ensures that training of employees occurs in a timely manner and completely and that documentation of training is maintained.
General Duties
- Maintains scientific knowledge through review of scientific literature, attending relevant scientific meetings and Recommends and evaluates new laboratory procedures and equipment.
- Prepares materials for customer education and Participates in marketing activities.
- Coordinates studies for research or in conjunction with other units/organizations.
- Responsible for training and education of lab personnel and guests.
Position requirements and experience
- Education and Experience Requirements – Bachelor’s and/or Master’s degree in biological or chemical sciences with demonstrated experience in a regulated laboratory environment (CLIA/CAP), and ASCP Certification in Molecular Biology.
- Required Experience in product/clinical/research assay development >2-5 years
- Demonstrated experience in oversight of personnel in CLIA/CAP laboratories.
- Demonstrated experience in implementing new methods in a CLIA-certified laboratory.
- Excellent interpersonal, verbal, and written communication skills; strong organizational and analytical skills; and the ability to work in a highly cooperative team environment as well as independently.
- CLIA/CAP Experience - BS: >5 years, MS: >3 years
- ASCP MB: Required
- ASCP Laboratory Management Certification: Preferred
- Management in CLIA/CAP: Minimum 3 years Preferred
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