QA Manager
Company: Prelude Corporation
Location: Laguna Hills
Posted on: February 28, 2026
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Job Description:
Job Description Job Description Description: 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
with a minimum 5 years of experience in clinical laboratory and
quality positions. MBA a plus.
Keywords: Prelude Corporation, Corona , QA Manager, Science, Research & Development , Laguna Hills, California
