Principal Biostatistician, Clinical Development
Clinical Outcomes Solutions
Lab Quality Manager – Moderate Complexity CLIA
Everly Health
full-time
Posted on:
Origin: • 🇺🇸 United States • Illinois
Visit company websiteSalary
💰 $100,000 - $120,000 per year
Job Level
SeniorLead
About the role
- Maintain laboratory licensure and accreditation (CLIA, CAP, NYS) through periodic renewals, new applications, method submissions and managing the proficiency testing program.
- Serve as the liaison between the clinical laboratory and accrediting agencies.
- Administer and manage the document control system, incident reporting system and personnel documentation.
- Review all laboratory procedures and validation documentation for compliance following regulation and guidance.
- Assure proper qualification of laboratory personnel according to regulatory standards.
- Perform regular internal quality audits in all laboratory sections; follow up with recommendations, corrective, and preventive actions as needed.
- Identify procedural and systemic compliance risks and recommend continuous improvements that complement existing practices.
- Review and follow up on non-conformances, deviations until resolution. Initiate corrective and preventative actions to address system deficiencies and drive implementation of corrective action plans.
- Oversee and manage quality system related meetings, collect and trend key performance indicators.
- Interface and collaborate with laboratory personnel to educate, provide training, and ensure compliance in all aspects of the clinical process.
- Lead and coordinate timely resolution of any audit findings.
- Lead and monitor deviations and corrective and preventative actions, ensuring a timely resolution and thorough documentation.
- Identify, assess, and manage quality risks or compliance concerns proactively and take immediate corrective action as required.
- Provide leadership and be a resource to staff regarding CLIA, CAP and related regulations and best practices, including maintaining knowledge of applicable regulations, providing consultation to staff regarding regulatory compliance.
Requirements
- Bachelor of Science degree in medical technology, laboratory sciences or scientific disciplines.
- Minimum 8 years' experience in clinical laboratories performing moderate complexity in vitro diagnostics testing in a CLIA lab.
- Ability to maintain accurate, organized, detailed and clear work documentation, records/logs, written communication.
- Demonstrated ability to exercise good judgment and work collaboratively on an interdisciplinary team.
- Effective verbal and written communication skills and attention to detail with an ability to work in a regulated environment
