The CLIA Quality Specialist III will support the company's compliance activities with Clinical Laboratory Improvements Amendments (CLIA), College of American Pathologists (CAP), and applicable state requirements. The CLIA Quality Specialist III role works closely with stakeholders to support a wide variety of departments and reports to the CLIA Quality Manager. This position may require travel.
- Maintaining all Quality records from internal audits of collection sites and report findings while consistently following inspection requirements
- Supporting Electronic Quality Manage System (EQMS) projects.
- Create, review and improve standard operating procedures
- Ensure compliance with all Standard Operating Procedures (SOP)
- Provide Quality training and competency assessment to staff at predefined frequencies.
- Collaborate with various departments to drive process improvement.
- Monitor the document control system to track completion.
- Assist with submissions and responses for internal audits.
- Create and maintain quality metrics.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Support routine Quality processes such as providing employee training, investigating non-conformances, and developing Quality metrics.
- Ensure that all policies, procedures, and records are reviewed and approved.
- Represent Quality at cross functional meetings.
- BS/BA degree in Life Sciences or related field.
- At least 4 years of laboratory experience.
- Proficient with CLIA and applicable State regulations
- Be able to work in a fast-paced environment with tight deadlines.
- Experience developing reports and presentations.
- Experience in utilizing Laboratory Information Management System (LIMS)
- Experience with managing an eQMS
- Strong organizational skills
- Demonstrates excellent verbal communication, technical writing and interpersonal skills.
- Ability to identify, analyze and solve problems.
- Proven attention to detail and accuracy
- Ability and willingness to travel (not to exceed 10%)
Co-founded by CEO Fred Turner and powered by a team of world-leading doctors, scientists, engineers, and health industry experts, Curative responded in March 2020 to the urgent need for COVID-19 testing, ultimately developing a network of thousands of testing sites across over 40 states and three CLIA-certified, high-complexity laboratories. As a result, Curative and its managed medical entities provided over 30 million COVID-19 tests and over 2 million COVID-19 vaccines.
Curative’s patient-facing services, healthcare facilities, integrated supply chain, and labs are part of a large platform we've built from the ground up that has allowed us to grow quickly and more efficiently than other healthcare companies. As a result, we were one of the first companies to respond to the pandemic providing COVID-19 testing at scale across the United States.
We are now implementing a new model of comprehensive healthcare delivery focused on the whole person's well-being: providing expanded healthcare and wellness services while also streamlining access to preventative care. We are setting out to change healthcare in the United States and fundamentally re-designing the way that patients interact with their healthcare and health insurance. By building a connected platform for managing the health of our patients, we believe that we can deliver a better healthcare experience at a lower cost and with better outcomes so that our patients can focus on getting and staying well. Our model delivers healthcare by investing in patient preventive health from the start, reducing the barriers to entry to traditionally complex care networks and eliminating the concern of unexpected medical bills. Curative will launch its first members-only healthcare offering in Austin, January 2023.