Director of Laboratory Compliance

2 weeks ago

King of Prussia, United States Genomind Inc. Full time
Job DescriptionJob Description

Job Summary:

The Director of Laboratory Compliance will oversee all aspects of regulatory laboratory compliance. The manager will serve as a resource and overseer for the laboratory staff in completing regulatory tasks. The manager will also perform all responsibilities of the Laboratory Technologist.

Essential Duties and Accountabilities:

  • Designated Quality Systems Manager
    • Ensures oversight of laboratory quality improvement and quality management.
  • Maintains CAP/CLIA/NYS compliance, and any other appropriate agencies, within the laboratory and accessioning teams. Ensures compliance with local, state, and federal clinical laboratory regulation and ensures:
    • Staff understanding and compliance with all regulatory standards
    • Staff readiness for laboratory inspection
    • Integration of regulatory changes and new standards
    • Laboratory Technologist Training and Competency Program is maintained
  • Obtains and updates State and CLIA licenses for any new tests and technologies
  • Oversees, reviews, and approves laboratory proficiency testing (PT) surveys
  • Maintains document control system for the company including original copies, controlled bench copies and controlled/uncontrolled copies within Document Control software
    • Assists/Oversees laboratory staff in initiation and revision of standard operating procedures (SOPs) for laboratory operation
  • Maintains documentation of Laboratory Event Management Log and Active Investigation forms
  • Reviews and approves all laboratory Quality Control (QC) records
  • Proactively maintains all State laboratory licenses as fully active
  • Provides educational support for staff members interested in laboratory compliance
  • Responsible for creating Monthly Quality Report, with participation from each department, and holding Monthly Quality Meeting
  • Performs all essential duties of the Laboratory Technologist
  • Performs additional duties as assigned

Education:

  • Minimum Education: Bachelor's Degree – Molecular Biology, Medical Technology or a related science.
  • Licensure & Certification: MB(ASCP), MLS(ASCP) certification or equivalent.
  • Note: Other combinations of formal education, training and experience may be considered

Experience:

  • 3-5 years training and experience in high complexity molecular testing, CAP/CLIA laboratory environment.
  • Competencies Needed:
    • Understanding of the basic concepts to maintain CAP/CLIA/NYS regulations over multiple lab locations.
    • Excellent pipetting skills with extreme attention to detail.
    • Understanding of general molecular techniques and technologies, including nucleic acid isolations, reagent management, quality assurance/quality control, real time PCR and laboratory information systems.
    • Must have strong computer skills particularly in Excel, independent worker, dedicated and goal oriented with ability to meet deadlines.
    • Position requires effective verbal and written communication skills as well as strong people skills.
    • Must possess visual and audio skills appropriate to complete above listed duties.
    • Responsive to necessary flexible and/or expanded schedule.
    • Handles emergency or crisis situations.

Working Conditions:

  • Physical Demands
    • Mostly sedentary work
    • Occasional prolonged standing/walking
    • Occasionally lifts supplies/equipment
    • Manual dexterity and mobility
    • Occasional reaching, stooping, bending, kneeling, crouching
  • Working Conditions
    • Exposed to potentially infectious material
    • May be exposed to toxic chemicals
    • Subject to hazards of flammable materials
  • Physical Requirement: The Physical Requirements described herein are representative of those which must be met by an employee to successfully perform the primary functions of this job. Reasonable accommodations may be made to enable individuals with disabilities who are otherwise qualified to perform the primary functions.

Job Classification: Exempt

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