DaVita - DeLand, FL
posted 5 months ago
The Technical Analyst II, QA (Lab) at DaVita is a pivotal role responsible for monitoring, reporting, and auditing the Quality Management System and Quality Assurance programs within DaVita Labs. This position ensures compliance with Federal and State regulations, including the Clinical Laboratory Improvement Agency (CLIA) and Good Clinical Laboratory Practices (GCLP). The analyst collaborates closely with clinical laboratory lane leaders and teammates to identify opportunities for improvement, develop plans, and execute projects aimed at achieving Continuous Quality Improvement while aligning with GCLP guidelines and regulatory requirements set forth by Federal (CMS/CLIA), State, and accrediting agencies such as the College of American Pathologists (CAP). In addition to adhering to corporate policies and procedures, the Technical Analyst II reviews and maintains technical documents that support clinical lab operations. Acting as a subject matter expert, the analyst participates in standard operating procedures (SOPs) and collaborates in procedural reviews, ensuring that all clinical laboratory technical documents comply with regulatory standards. The role also involves reviewing existing laboratory and business processes to identify gaps and opportunities for enhancement, actively engaging in departmental continuous improvement initiatives, and providing guidance based on regulatory and technical knowledge. The analyst is responsible for leading and participating in special projects to ensure quality, preparing and distributing reports for external partners and vendors, and reviewing change requests and planned deviations for potential impacts on quality. Furthermore, the role includes providing direct QA support for laboratory operations, performing training and competency assessments for Technical Analysts I & II, managing deviations or nonconformance, conducting investigations, and developing corrective action/preventative action plans. The Technical Analyst II also executes an audit program, independently plans and conducts audits, and monitors corrective actions to ensure effectiveness. This position plays a crucial role in analyzing and tracking quality-related metrics and partnering with clinical lab lanes to ensure accurate patient testing and regulatory alignment.