DaVita - DeLand, FL

posted 5 months ago

Full-time - Mid Level
DeLand, FL
Ambulatory Health Care Services

About the position

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.

Responsibilities

  • Monitor, report, and audit the DaVita Labs Quality Management System and Quality Assurance programs.
  • Identify opportunities for Continuous Quality Improvement in collaboration with clinical laboratory lane leaders.
  • Develop, plan, and execute projects to ensure alignment with GCLP guidelines and regulatory requirements.
  • Review and maintain technical documents supporting clinical lab operations.
  • Act as a subject matter expert in technical areas supported by the lab.
  • Participate in procedural reviews and collaborate in standard operating procedures (SOPs).
  • Review clinical laboratory technical documents for regulatory compliance.
  • Collaborate with lane leaders to maintain appropriate records for regulatory adherence.
  • Engage in departmental continuous improvement and quality initiatives.
  • Provide guidance and recommendations based on regulatory and technical knowledge.
  • Lead and participate in special projects to ensure quality.
  • Prepare and distribute reports for external partners and vendors regarding quality projects.
  • Review change requests and Planned Deviations for potential impact on quality.
  • Manage deviations or nonconformance and perform investigations.
  • Develop corrective action/preventative action plans and ensure documentation aligns with regulatory requirements.
  • Perform Root Cause Analysis (RCA) and track/report events and action plans.
  • Execute the audit program, including internal, client, regulatory, and accrediting agency audits.
  • Independently plan and execute audits, assemble and distribute audit findings, and provide guidance for corrective action.
  • Develop responses to audit findings and track them to closure.
  • Monitor corrective actions to completion and verify effectiveness.
  • Analyze and track quality-related metrics and provide technical recommendations on instrument validations and quality control programs.

Requirements

  • 4-6 years of experience in a relevant field.
  • Associate's degree as a Medical Laboratory Technician (MLT) or Bachelor's degree in MLS/MLT, Clinical Laboratory, or Biological science required.
  • Minimum of four (4) years' clinical lab experience required.
  • Knowledge/experience with CLIA, CAP, and GCLP standards preferred.
  • Intermediate computer skills and proficiency in MS Word, Excel, Outlook, PowerPoint, MS Project, and Visio required.
  • Team leadership experience preferred.

Benefits

  • Comprehensive benefits including medical, dental, and vision coverage.
  • 401(k) match and paid time off (PTO) with cash out options.
  • Family resources and EAP counseling sessions.
  • Access to Headspace® for mental wellness.
  • Backup child and elder care support.
  • Maternity and paternity leave.
  • Professional development programs and online training courses through StarLearning.
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