Manager, Clinical Laboratory (E&D) - Aliso Viejo, CA

Compensation: $135,000-$142,000/year. You are eligible to a Short-Term Incentive Plan with the target at 10% of your annual earnings, terms and conditions apply.

Manager, Clinical Laboratory (E&D) - Aliso Viejo, CA

Shift: Monday - Friday 9am-5:30pm 

Job Overview:

Advanced and expert management position as Manager in the Clinical Laboratory at Ambry Genetics. This position is responsible for operational oversight of a specific laboratory workflow. The Manger is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in the duties and responsibilities. This position requires a Clinical Laboratory Scientist license from the California Department of Public Health. 

Essential Functions:

• Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with the laboratory's procedures for specimen handling and processing, data analyses, reporting (when applicable) and maintaining records of patient test results, as established by the Laboratory Director.
• Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
• Managing the inventory of reagents and consumables to ensure sufficient supply chain to support laboratory operations.
• Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.
• Assuring that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
• Identifying training needs and assuring that each individual performing tests receives regular training and education appropriate for specific laboratory workflow.
• Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.
• Providing regular feedback to direct reports on their performance.
• Adheres to and reviews the laboratory's quality control policies, with emphasis on documentation of all quality control (QC) and quality assurance (QA) activities, including instrument and procedural calibrations and maintenance performed. As a subject matter expert, able to independently write QC/QA documentation, including standard operating procedures and work instructions, quality event reports (QER), and corrective action/ preventative action (CAPA) plans.
• Assists the Sr Manager and/or Laboratory Director with establishing a quality management review (QMR)/QC program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.
• Responsible for monitoring the analytic test performance of the specific laboratory workflows the Manger is providing operational oversight of. This includes, but is not limited to, proactive monitoring of established operational metrics, and communication and escalation to Sr Manager and/or Laboratory Director when the test systems deviate.
• Assists the Sr Manager and/or Laboratory Director with selection of appropriate test methodology for a specific laboratory workflow, the verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. Can write and review verification/validation plans and reports.
• Ensures testing personnel adhere to laboratory policies for safety, personal protective equipment (PPE) and hazardous waste disposal.
• Other duties as assigned 

Qualifications:

• A bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution.  
• Clinical Laboratory Scientist license from the California Department of Public Health: 
• Clinical Genetic Molecular Biologist Scientist (CGMBS), preferred, or
• Clinical Laboratory Scientist (Generalist)
• This position requires a minimum of 8 years prior work experience in a laboratory certified under CLIA and at least 3 years of supervisory experience leading direct reports (usually in the U.S.). 
• General: Technical knowledge of laboratory testing and terminology is required. Capable of e