Clinical Lab Manager
- Santa Clara, CA
Amazon is focused on protecting the health and safety of our employees while continuing to serve people who need our services more than ever. Regular testing on a global scale across all industries would both help keep people safe and help get the economy back up and running. But, for this to work, we as a society would need vastly more testing capacity than is currently available. Unfortunately, today we live in a world of scarcity where COVID-19 testing is heavily rationed. Until we have an effective vaccine available in billions of doses, high-volume testing capacity would be of great help, but getting that done will take collective action by NGOs, companies, and governments.
For our part, Amazon has begun the work of building incremental testing capacity.
• Provide day-to-day management of clinical lab and of testing personnel and reporting of test results in a high complexity, CLIA certified laboratory• Drive continue improvement of standard operating procedures for diagnostic assays.
• Manages efficient teams while driving improvements in assay quality (as measured by precision, specificity, and sensitivity of tests)
• Responsible for continual evaluation and improvement of laboratory safety.
• Manage SOP documentation and versioning.
• Oversee design of experiment creation and execution, including: laboratory testing, equipment characterization, assay development and validation.
• Hire and develop the world's most talented laboratory technicians.
• Assume primary responsibility for the proper performance of all laboratory procedures and reporting of test results, in the absence of the Director
• Provide professional and managerial leadership in the laboratory as well as taking responsibility for the interviewing, selection, onboarding, and training of staff
• Consistently exercise discretion and independent judgment in providing day-to-day management of high complexity test performance by qualified testing personnel
• Directly manage lab testing supervisors, including providing guidance, direction, and oversight of testing activities, and assessing the competency of lab personnel
• Be accessible to test personnel at all times via on-site, telephone, or electronic support
• Be onsite to provide direct supervision when high complexity testing is performed by any qualified testing personnel
• Monitor test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained
• Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning
• Evaluate and document the performance of all testing personnel, including medical lab technicians
• Coordinate laboratory activities to complement the duties and responsibilities of the Laboratory Director
• Maintain and oversee proficiency testing (PT) program, report results
• Work cooperatively in a team environment supporting senior laboratory and management staff
• Ensure operational compliance with the laboratory's Quality Management Systems (QMS) Program and delivery of routine QMS associated metrics
• Monitor key financial, quality, and efficiency indicators and recognizes opportunities for improvement
• Master's degree in a chemical, physical, biological sciences
• 5+ years of supervisory experience in a clinical laboratory
• 5+ years of relevant laboratory experience
• 5+ years training or experience in high-complexity testing
• 3+ years of experience working in the designated laboratory specialty in a medical laboratory
• 2+ years of experience of diagnostic testing in high complexity CLIA labs
• Good understanding of CAP and CLIA regulations
• PhD in a chemical, physical, biological or clinical laboratory science
Note: This position requires sustained work in a laboratory that will be receiving biological specimens that may include viruses for infectious diseases, including the COVID-19 virus (which is known to cause the coronavirus disease). Accordingly, this role involves the risk of infection. Amazon has implemented appropriate safety policies, training, processes, and equipment as per applicable guidelines.
Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.
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