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CLIA Quality & Compliance Manager

Snap Staffing

CLIA Quality & Compliance Manager

San Diego, CA
Full Time
Paid
  • Responsibilities

    CLIA Quality & Compliance ($125 - $140k DOE, San Diego, CA)

    SNAPSHOT!

    Looking for a chance to join one of the most exciting oncology diagnostic companies in San Diego? THEN READ ON! The Quality & Compliance Manager is responsible for overseeing the Quality Management System including quality control to ensure compliance with regulatory agencies. The position will also be responsible for managing the quality processes for different lots of reagents, records, quality control testing and processes as it relates to validations and daily use in the CLIA laboratory. The position will utilize existing protocols and update as needed to improve the quality and efficiency of laboratory testing. The ideal candidate will have background in clinical laboratory quality.Our client offers an excellent comprehensive package.

    Immediate opening for a CLIA Quality & Compliance Manager who possesses:

    • 8+ years of related experience and a bachelor's degree in a related discipline, or at least 6 years of experience and a master's degree, or equivalent combination of education and experience.
    • CLIA Lab regulatory compliance and quality assurance in biotech, hospital, or reference lab
    • Experience working with cross-functional teams.
    • Comprehensive understanding of State and Federal laws and quality assurance requirements pertaining to clinical laboratory testing and operations, and accreditation standards (CLIA, CAP, CDPH, NYDOH).
    • Commitment to quality, accuracy, and efficiency.
    • Strong knowledge of root cause analysis, problem solving and analytical skills.
    • Experience with implementing lead management and Six Sigma certification preferred.
    • Experience in preparing and managing laboratory inspections.
    • High level expertise and knowledge in understanding clinical laboratory control procedures.
    • Experience in writing and implementing policy & procedures in the clinical laboratory settings.
    • Ability to be an initiative-taker and work under minimum supervision.
    • Experience with FDA Quality Systems Regulations as it relates to LDT submission and VALID act highly desired.
    • Experience in a clinical laboratory setting preferred. Clinical Laboratory Scientist license and/or ASCP certification highly preferred.
    • Strong understanding of scientific laboratory procedures with ability to differential RUO and LDT assay structure and the adherence to Quality System standards.

    KEY RESPONSIBILITIES INCLUDE:

    • Oversee and manage CLIA Quality Systems and develop detailed action plans, define resource requirements, performance measurements, and quality metrics.
    • Support and guide laboratory staff to ensure alignment with the overall quality goals and objectives.
    • Ensure laboratory compliance with all accrediting agencies (CLIA, CAP, CDPH, NYDOH and other states).
    • Works with lab management and licensed staff to ensure licensing and certification requirements are kept up to date.
    • Serve as a designated Management representative for the CLIA/CAP quality meetings as well as at a company level as it relates to Quality Systems related issues.
    • Facilitate inspections and audits with regulatory agencies and perform appropriate follow-up responses to findings.
    • Manage internal and external proficiency testing programs (ex. CAP PT) as well as external validation studies (ex. Clinical utility, assay performance, etc.).
    • Keep up with any changes in regulations as it relates to clinical laboratory testing and accreditations and keep management appraised of any recommended changes needed to ensure compliance.
    • Responsible for ordering and administering appropriate Proficiency Programs including alternate proficiency programs as necessary for newly developed LDTs.
    • Responsible for CAPA and internal quality assurance incidents and trends and communication of issues to the management team.
    • Conducts regulatory and compliance awareness training for laboratory staff.
    • In collaboration with lab management enforces Quality Management Plan and related compliance protocol to ensure lab personnel meets requirements.
    • Drive improvements and monitor Quality Metrics/KPI’s and performance measures in the laboratory.
    • Perform trending analysis (Quality Metrics, KPI’s, CAPA) on regular basis.
    • Utilize LIS/LIMS to monitor quality control process, generate reports and presents trending analysis with recommendations to lab management.
    • Conduct supplier audits, quality, monitor and disqualify suppliers and suppliers as required.
    • Frequently revises the compliance program and related documentation per recent changes in laws and/or as a result of the ongoing quality improvement initiatives.
    • Conducts regular Lab Management Quality Review meetings.
    • Will be part of the Safety Team and expected to actively participate in regular safety meetings by making suggestions for improvements. May be asked to perform duties of the Safety Officer.