Clinical Lab QA Analyst



IT, Quality Assurance
Chicago, IL, USA
Posted on Thursday, May 11, 2023
Everly Health's mission is to transform lives with modern, diagnostics-driven care, and we believe that the future of healthcare is meeting people where they are. Headquartered in Austin, Texas, Everly Health is the parent company to Everlywell, Everly Health Solutions, Natalist, and Everly Diagnostics. We've set a new standard of people-focused, diagnostic-driven care that puts patients at the center of their own health journey.
Our infrastructure guides the full testing experience with the support of a national clinician network that's composed of hundreds of physicians, nurses, genetic counselors, PharmDs, and member care specialists. Our solutions make world-class virtual care more attainable with rigorous clinical protocols and best-in-class science to tackle some of the healthcare industry's biggest problems.
We are hiring a Clinical Lab QA Analyst to play a vital role in assistance of implementation and maintenance of our laboratory’s quality management system and biological/ facilities safety.
Reporting directly to the Quality Assurance Supervisor you will help establish and manage and support a high-performing QA team. You will help the laboratory execute quality centric goals and objectives while constantly maintaining regulatory compliance for the laboratory that is CLIA certified and CAP accredited. In addition to improving overall quality, you will serve in a coaching capacity for the operational leadership in the creation and implementation of processes, policies, and procedures.
We are in high growth, startup mode and need someone who is willing to get their hands dirty. If you are passionate about quality and looking for an opportunity to learn, build, optimize, and grow, Everlywell is the place for you.

What You'll Do:

  • Ensures regulatory preparedness at all times by maintaining procedure manuals, training records, validation documents, personnel records, quality documentation, etc. while adhering to CAP, CLIA, and OSHA standards
  • Maintain procedural manuals in applicable areas of the laboratory
  • Participates in laboratory audits and accreditation inspections, at the capacity requested by QA management
  • Acts as a liaison between all departments in the laboratory (including Pre-Analytic, Analytic, and Post-Analytic) and the QA department to answer quality-related questions, implement policies/procedures, and enforce quality objectives
  • Ensures the Document Control System maintains the integrity and organizational standards set by QA management
  • Executes minor changes to controlled documents (as requested) in the Document Control System
  • Ensures that all equipment, machines, or instruments are maintained, inspected, and calibrated
  • Keeps records of applicable service and maintenance agreements as well as logs, as applicable
  • Executes verification of laboratory documentation (e.g., temperature/humidity monitoring, various logs, etc.) on a routine basis established by the QA department
  • Maintains knowledge of proper specimen collection procedures, including patient preparation, labeling, handling, preservation, processing, preparation, transportation, and storage of specimens
  • Obtains QA documentation and data to assist in the creation of monthly/annual Quality Reports, as well as establish effective systems to monitor accuracy assessments and data quality throughout the laboratory
  • Manages laboratory staff contact information
  • Conducts QA procedures to monitor core performance and notifies QA management and area supervisor of performance issues as the issues develop, and work with the area supervisor to establish a remediation plan
  • Provides orientation/training to all new hires as well as current staff, as needed
  • Participates on subspecialty committees, corporate committees, and regional committees as needed
  • Accepts responsibilities delegated from the QA Supervisor or Director (the QA Supervisor or Director is permitted to delegate responsibilities to the QA Analyst, if the QA Analyst is qualified to perform the responsibility)
  • Maintains licensures as applicable and participates in continuing education; ensure staffing does the same
  • Performs other duties as assigned

Who You Are:

  • Associate’s Degree in Science or related subject, or Medical Laboratory Scientist (MLS) or equivalent with the American Society of Clinical Pathology or acceptable equivalent.
  • 3-5 years in quality assurance is preferred
  • Previous laboratory experience is preferred
  • Clinical laboratory experience is preferred
  • Highly proficient in Microsoft Excel
  • Experience with Asana a plus
  • Detail-oriented, self starter who takes pride in the quality of your work
  • Curious and always asking ‘why?’ and ‘how can we do this better?’
  • Prior experience in a fast-paced startup environment a plus
You'll Love Working Here:
· Venture backed by top-tier firms
· The opportunity ahead knows no bounds
· Open vacation policy for salaried team members
· Front Loaded PTO for hourly team members
· Employee discounts
· Paid parental leave
· Health benefits
· 401(k)
Everly Health is committed to providing equal employment opportunities in all employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship status, marital status, age, disability, protected veteran status, sexual orientation or any other characteristic protected by law.
HIPAA Disclaimer: This role will be in an environment that has access to protected health information (PHI) and all security standards to protect PHI must be followed.