This is an exciting opportunity for an independent, creative, service-oriented individual to help build clinical sequencing laboratory services. The candidate will be responsible for daily supervision of a high throughput clinical laboratory including oversight of laboratory technologists, technical trouble-shooting validation and testing processes, reviewing lab results, developing and writing operational procedures, monitoring laboratory key performance indicators, quality metrics, and the QC program, timely reporting of quality event reporting to the laboratory director and to quality management, and provide regulatory, due diligence and internal auditing support. Must have experience and be able to apply regulations to clinical diagnostic operations.
- Manage the daily operations of assigned laboratory personnel to ensure that specimens are properly shipped and received, tests are performed accurately and efficiently, and results are reported in a timely manner.
- Perform pre-analytical, analytical and post analytical test process and evaluate results produced relative to the diagnostic assessment.
- Evaluate data for accuracy and verify any questionable finding with proper documentation, thorough investigation, and appropriate follow-through.
- Assist with designing processes and procedures to ensure efficient turn-around time and accuracy of results.
- Prepare and manage laboratory budget.
- Coach and mentor staff on technical expertise and assist in evaluation of employee competencies.
- Engage in continuous process and service improvement. Make and implement recommendations to improve operational efficiency and implement new services for areas of responsibility.
- Requires strict adherence to quality control guidelines to ensure integrity of laboratory specimens and accuracy of results.
- Ensure all work is in accordance with state and Federal regulations, organizational policy, and accreditation/compliance requirements.
- Assist in maintaining CAP and other accreditation and regulatory agency standards and regulations.
- Performing bench work and other duties as required including shift work.
QUALIFICATIONS & EXPERIENCE
- Bachelor's degree in biology or related scientific discipline and a
- Extensive experience of clinical molecular experience
- Previous Supervisory/Management experience in a clinical laboratory setting.
- Quality Assurance and Quality Control applications in clinical diagnostics
- Must be detail-oriented, organized, with excellent verbal and written communication skills.
- Ability to troubleshoot technical applications and work independently under pressure of deadlines and a fast-paced, high throughput team environment.
- Practical knowledge of routine laboratory equipment and procedures.
- Experience with LIMS and laboratory automation highly desired.