CLIA Quality Specialist II

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Job description

Curative was founded in March 2020 to scale COVID-19 testing. We took a full-stack approach to testing and were one of the first labs to launch an FDA-authorized mouth swab test that patients could do themselves. Since then, we've done over 25 million COVID-19 tests and 2 million vaccinations. Curative is taking on fundamentally changing US healthcare. We are building a vertically integrated platform for managing the health of our patients. No more silos or navigating multiple companies to seek care and unexpected bills. We're rebuilding from first principles, focusing on patients and delivering the highest quality care, not billing. Preventative care will be made easy and accessible to our patients, facilitated by the lab infrastructure we built for the scale of the COVID-19 pandemic. The work we've done during the pandemic has given us the resources and lessons to achieve this mission.

We are seeking a CLIA Quality Specialist II. This position 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 role works closely with stakeholders to support a wide variety of departments.

RESPONSIBILITIES:

• Provide day-to-day quality support for the clinical laboratory and activities.
• Assist in maintaining the Equipment program.
• Create, review, and improve standard operating procedures.
• Perform and document internal audits and makes recommendations for corrective actions.
• Create and maintain quality metrics.
• Develop and maintain Quality records.
• Supporting Electronic Quality Manage System (EQMS) initiatives and projects.
• Provide Quality training and competency assessment to various organizations.
• Collaborate with various departments to drive process improvement initiatives.
• Manage the document control system to help automate and control and tracking of documents.
• Is the liaison for state and regulatory submissions.
• Provide QA oversight for the laboratory and represent work with cross-functional teams to resolve discrepancies and drive for closure

EDUCATION / EXPERIENCE REQUIRED:

• BS/BA degree in Life Sciences or related field.
• At least 3-5 years of quality experience in the Life Sciences Industry.
• Proficient with CLIA regulations, California Laboratory regulations, and NY State Laboratory regulations.
• Be able to work in a fast-paced environment with tight deadlines.
• Experience with utilizing quality software and systems.
• Experience in utilizing Laboratory Information Management System (LIMS).
• Demonstrates excellent verbal communication, technical writing, and interpersonal skills.
• Ability to identify, analyze and solve problems.
• Proven attention to detail and accuracy.