Manager

• 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.

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