GENERAL PURPOSE OF THE JOB

The Technical Analyst II, QA (Lab) is responsible for the following:

• Monitors, reports, and audits the DaVita Labs Quality Management System and Quality Assurance programs in accordance with Federal and State regulations, Clinical Laboratory Improvement Agency (CLIA) and Good Clinical Laboratory Practices (GCLP).
• In collaboration with clinical laboratory lane leaders and teammates identifies opportunities, develops, plans, and executes projects to ensure Continuous Quality Improvement and alignment with GCLP guidelines as well as Federal [CMS/CLIA], State, and accrediting agency [College of American Pathologists (CAP)] clinical regulatory requirements.
• Adheres to corporate standard policies and procedures related to job performance, customer interactions, employee relations, and information confidentiality.
• Reviews and maintains technical documents supporting the clinical lab and operations.

This position reports to the Manager, Quality (Lab)

• Acts as subject matter expert in technical area(s) supported
• Participates in transactions in accordance with standard operating procedures(SOPs) and actively collaborates in procedural reviews, seeking lane specific expertise as needed
• Reviews and monitors clinical laboratory technical documents to ensure regulatory compliance
• Collaborates with lane leaders to verify and ensure that appropriate records are maintained to document adherence to regulatory requirements
• Reviews existing laboratory and business processes to identify gaps/opportunities
• Actively engages in departmental continuous improvement/quality initiatives
• Provides guidance and continuous improvement recommendations based on both regulatory and technical knowledge
• Leads and/or actively participates in special projects to ensure quality
• Prepares and distributes reports for external partners and vendors to manage quality projects and programs.
• Reviews change requests for potential impact on quality.
• Reviews Planned Deviations and Something Happened Intake forms (SHIF) for potential impact on quality
• Reviews corrected results for potential impact.
• Provide direct QA support for laboratory operations and closely integrated functions
• Performs training and competency assessment for Technical Analyst I & II. Reviews projects, test plans, reference documents, and research articles to gain knowledge and experience.

Deviation or nonconformance management

• Investigation
• Development of corrective action/preventative action plans.
• Ensure documentation is complete and aligns with regulatory requirements.
• Perform Root Cause Analysis (RCA).
• Track/reports events and action plans
• Follow up on action plans

Execution of audit program (including but not limited to internal, client, regulatory, and accrediting agency audits)

• Independently plans and executes audits
• Assembles and distributes audit findings
• Provide guidance for corrective action.
• Develops, compiles, and executes responses to audit findings
• Track audit findings to closure
• Monitor corrective action to completion and verify for effectiveness.

Responsible for quality related metrics

• Analyze and track metrics related to quality.
• Partner with clinical lab lanes to monitor data and provide technical recommendations on instrument validations/verifications, proficiency testing, and instrument quality control programs to ensure accurate patient testing and regulatory alignment.

EDUCATION AND EXPERIENCE

• 4-6 years experience required
• 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 computers sills and proficiency in MS Word, Excel, Outlook, PowerPoint, MS Project, and Visio required
• Team leadership experience preferred

What We'll Provide:

More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings.

• Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
• Support for you and your family: Family resources, EAP counseling sessions, access Headspace, backup child and elder care, maternity/paternity leave and more

• Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita's online training platform StarLearning.

Applications are accepted on an ongoing basis