QA Manager
About The Position
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.
Requirements
- Bachelor’s Degree in science
- Minimum 5 years of experience in clinical laboratory and quality positions
Nice To Haves
- MBA a plus
Responsibilities
- Monitoring the pre-analytical, analytical and post analytical process of the clinical laboratory services
- Ensuring compliance with regulatory, state and accreditation requirements
- Overseeing, planning, coordinating, and managing quality assessment programs
- Directing all quality activities of all pre-examination, examination and post-examination phases in the laboratory
- Managing all phases of Proficiency Testing activities
- Implementing and overseeing 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
- Implementing and maintaining the web-based Document Control System
- Acting as the primary interface with external Quality Auditors and Regulatory Agencies during on-site audits, license and permit renewals, and follow-ups
- Coordinating and providing relevant documentation to Regulatory Agencies to enable timely product/ service registrations
- Responsible for the application and re-validation of Medicare licenses
- Implementing meaningful QA metrics for pre-analytical, analytical and post-analytical phases of laboratory testing
- Presenting quarterly QMS metrics to management and staff
- Ensuring adherence to environmental and safety protocols in compliance with State and Federal regulations
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What This Job Offers
Job Type
Full-time
Career Level
Manager
