Interpath Laboratory

  • Off-Site Laboratory Compliance Officer

    Location US-OR-Pendleton
    Job ID
    2018-2669
    # Positions
    1
    Category
    Technical/Laboratory
    Schedule
    M-F
  • Equal Opportunity Statement

    EOE Disabled/Veteran

    Expectations for all Employees

    Support the organization's mission, vision, and values by exhibiting an ongoing commitment to the highest standards in all phases of laboratory operations. Assume service-oriented attitude to gain a sense of pride and accomplishment. Accepts the team approach with dedication and commitment towards all work performed.

    Overview

    This position ensures compliance – that testing is being performed according to applicable state and federal regulations for off-site laboratories. In addition, this position provides limited technical support and guidance for medical directors and technical consultants that oversee compliance at laboratory sites outside the batch laboratory. This position also maintains a vibrant and robust quality assurance program, enabling consistently high quality of results.

    Qualifications

    • Education: Bachelors degree in a certified MT program.
    • Licensure/Certification: ASCP preferred, other national certifications considered
    • Experience: 10 years of laboratory experience

    Responsibilities

    1. Act as chairperson for the Oversight of Off-site Laboratories (COOL)
    • Ensure that the duties of all COOL members are being completed on an on-going basis
    • Hold regular (at least once per month) COOL meetings, establishing action items and following up to ensure completion
    • Communicate regularly with the technical manager regarding all COOL matters
    • Provide quality assurance (QA) training and mentorship for all COOL members and site technical leads where needed
    • Ensure COOL site tracker is up to date with compliance documents and inspection information
    1. Act as a regional member of the COOL, covering the Pendleton or other assigned region
    • Oversee inspection and accreditation processes at all laboratories assigned
    • Visit and audit regional moderate complex testing sites on at least a quarterly basis
    • Visit and audit waived testing sites on at least a semi-annual basis
    • Assist with the validation of new tests and equipment at regional sites
    • Perform (or ensure performance of) monthly reviews of QC, proficiency testing, maintenance and temperature logs, and assist with the evaluation of linearities and calibration verifications
    • Provide required training of new technicians and re-training of existing technicians
    • Lead the technical aspect of site start-ups within the region, ensuring the following are completed: technical details on the site start-up form; CLIA applications; SOPs and forms; test method validations, on-site personnel training
    • Ensure SOPs, policies and logs are up-to-date
    1. Other Duties
      • Track and assist, where needed, all CAP, COLA and CLIA inspections corporate-wide
      • Oversee the proficiency testing (PT) program corporate-wide
    • Ensure that all appropriate PT materials are ordered on an annual basis
    • Ensure that all PT is being performed, reported and corrective actions taken where needed
      • Manage the document control of all off-site documents (SOPs, policies and forms)
      • Support the development, implementation and completion of all Interpath Quality (IQ) and other process improvement projects corporate-wide
      • Respond to inside and outside questions of a technical nature. This will require the maintenance of a broad knowledge range of technical subjects
      • Where assigned, oversee the management and completion of corporate-wide technical projects

    OSHA Category

    This position performs tasks that involve exposure to blood, body fluids and/or tissues. All employees performing these duties are offered the opportunity to receive the Hepatitis-B vaccination series.

    General Physical Requirements

    • Regularly exposed to infection by handling potentially infectious samples.
    • Typically stands for extended period of times
    • Lifts up to 25 pounds.
    • Climbs stairs on a regular basis.
    • Responsible for wearing appropriate protective gear: e.g., lab coat, gloves, goggles, face shield.

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