QA Manager at Prelude Corporation – Laguna Hills, California

Responsible for monitoring the pre-analytical, analytical and post analytical process of the clinical laboratory services and ensuring compliance with regulatory, state and accreditation requirements.

• Oversees, plans, coordinates, and manages quality assessment programs designed to ensure compliance with established standards of laboratory practice, CLIA, State regulations, CAP, and other laboratory accrediting agencies.
• Works with the Medical Director to oversee, plan, coordinate, and manage quality assessment programs.
• Includes the responsibility of directing all quality activities of all pre-examination, examination and post-examination phases in the laboratory.
• Responsible for managing all phases of Proficiency Testing activities at PreludeDx.
• Implement and oversee CAPA (Corrective and Preventative Actions), validations, inspections, document control, regulatory affairs, and problem resolution.
• Producing and/or overseeing the creation of documentation as it applies to quality assurance and regulatory affairs and manage document retention and control.
• Implements and maintains the web-based Document Control System at PreludeDx.
• Act as the primary interface with external Quality Auditors and Regulatory Agencies during on-site audits, license and permit renewals, and follow-ups
• Coordinate and provide relevant documentation to Regulatory Agencies to enable timely product/ service registrations
• Responsible for the application and re-validation of Medicare licenses.
• Implementation of meaningful QA metrics for pre-analytical, analytical and post-analytical phases of laboratory testing.
• Responsible for presenting quarterly QMS metrics to management and staff.
• Responsible for ensuring adherence to environmental and safety protocols in compliance with State and Federal regulations.

Bachelor’s Degree in science with a minimum 5 years of experience in clinical laboratory and quality positions. MBA a plus.