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Laboratory Compliance Manager


King of Prussia, PA

Posted 2 weeks ago

Seeking a Laboratory Compliance Manager for a direct hire opportunity in King of Prussia, PA. Our client is a leading provider of individualized precision medication management. Their lab test and precision medicine software turn patient genetic data into actionable treatment insights that help providers and patients narrow down medication choices and personalize dosing to achieve better outcomes. The Laboratory Compliance Manager will oversee all aspects of regulatory laboratory compliance. They 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 Responsibilities:

  • 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.
Contact the Recruiter:
Jenni McBride Headshot
Jenni McBride
Manager, Talent Advisory Solutions
Jenni McBride Headshot
Jenni McBride
Manager, Talent Advisory Solutions
I had an amazing time working with Jenni throughout the recruitment process. She made sure to check in with me every step of the way and even gave me tips about interviewing. I definitely wouldn’t hesitate to work with her again.
– Nia H.
Messina Group is an Equal Opportunity Employer
We provide and promote equal employment opportunities without regard to race, color, religion, age, sex, national origin, disability status, genetics, veteran status, sexual orientation, gender identity or expression.
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Laboratory Compliance Manager

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