Clinical Quality Specialist
- Palo Alto, 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.
This position is responsible for the execution and effectiveness of Clinical Laboratory Quality Management System (QMS) in accordance with the Amazon's QMS and regulatory standards such as Current Good Manufacturing Practices (cGMPs), ISO 15189, 21 CFR Part 493 (CLIA), College of American Pathologists (CAP), and New York State Department of Health (NYSDOH).
• Ensure that processes needed for the quality management systems (ISO 15189, 21 CFR Part 493 CLIA, CAP) are established, implemented, and maintained.
• Creating, updating, reviewing and developing QMS standard operating procedures (SOPs) and other supporting work instructions per CLIA, CAP, and NYSDOH regulations.
• Support internal and external audits (CLIA, CAP, NYSDOH, supplier, customer/partner), and coordinate appropriate action with all the impacted site teams on major and critical audit findings
• Provide technical leadership to implement quality processes including statistics-based variation reduction, control planning, mistake proofing, and Laboratory Process Control.
• Lead problem identification/solving and continuous quality improvement (CQI) activities in the production process with all involved areas of the site.
• Originate, review, and execute qualification, validation, and Design of Experiment (DOE) protocols for equipment, facilities, utilities, processes and computer systems
• Resolve process deviations with investigations, including determining and issuing appropriate Corrective Actions/Preventive Actions (CAPAs) and CAPA effectiveness reviews
• Lead quality key performance indicators (KPI) monitoring and reporting
• Analyze process capability data and other quality metrics to ensure that processes meet expectations
• Responsible for Control Plans and Failure Mode & Effects Analysis (FMEA) on all validated systems.
• Schedule and perform assigned laboratory audits and ensure timelines for audit steps (pre-work, conducting audit, issuance of audit report, corrective action and preventive action receipts) meet established expectations. Maintain industry current knowledge, application, and certification status for various technical and quality auditing topics.
• Maintain broad-based expertise of Good Laboratory Practices (GLPs), industry policies, procedures and guidelines, regulatory requirements, etc. that are pertinent to laboratory testing of human specimens
• Lead initiatives and drive results for all quality aspects of site projects, as assigned, to maintain the effectiveness and efficiency of the site quality systems to ensure regulatory expectations are met
• Bachelor's Degree in Science, Chemistry, (Micro-) Biology, Engineering or equivalent
• Minimum of 5 years of manufacturing, laboratory, technology, or quality operation experience within FDA, CAP CLIA or ISO regulated industry
• At least 3 years of Quality Assurance experience in working within CLIA and CAP certified laboratories
• Solid knowledge of CAP, CLIA, ISO 15189, including successfully having completed CLIA/CAP inspections.
• Fluency in Lean Manufacturing, Manufacturing Process Control and/or Six Sigma
• Experience conducting FMEAs/ Risk Management and performing audits of testing laboratories
• Ability to work independently with limited supervision in a virtual-management environment
• "Subject Matter Expertise", including knowledge and demonstrated application in Quality Systems, Complaint Investigation and cGLP
• Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization
• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders, driving results/impact for critical business / compliance initiatives.
• Demonstrated ability for process improvement and to create/implement simple, compliant systems in diverse areas.
• Knowledge and expertise in application of Quality Risk Management pertaining to auditing, above-site function/processes, and technical processes.
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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