The CLIA Quality Specialist II will support the company' 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.
1.0 Minimum Requirements:
- 1.1 BS/BA degree in Life Sciences or related field.
- 1.2 At least 3-5 years of quality experience in the Life Sciences Industry.
- 1.3 Proficient with CLIA regulations, California Laboratory regulations, and NY State Laboratory regulations.
- 1.4 Be able to work in a fast-paced environment with tight deadlines.
- 1.5 Experience with utilizing quality software and systems.
- 1.6 Experience in utilizing Laboratory Information Management System (LIMS).
- 1.7 Demonstrates excellent verbal communication, technical writing and interpersonal skills.1.8 Ability to identify, analyze and solve problems.
- 1.9 Proven attention to detail and accuracy.
2.0 Duties and Responsibilities:
- 2.1 Provide day to day quality support for the clinical laboratory and activities.
- 2.2 Assist in maintaining the Equipment program.
- 2.3 Create, review and improve standard operating procedures.
- 2.4 Perform and document internal audits and makes recommendations for corrective actions.
- 2.5 Create and maintain quality metrics.
- 2.6 Develop and maintain Quality records.
- 2.7 Supporting Electronic Quality Manage System (EQMS) initiatives and projects.
- 2.8 Provide Quality training and competency assessment to various organizations.
- 2.9 Collaborate with various departments to drive process improvement initiatives.
- 2.10 Manage the document control system to help automate and control and tracking of documents.
- 2.11 Is the liaison for state and regulatory submissions.
- 2.12 Provide QA oversight for the laboratory and represent work with cross functional teams to resolve discrepancies and drive for closure
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.