Laboratory Director for Quality and Safety

6 days ago


St Louis, Missouri, United States Join Parachute LLC Full time
Job Title:

Laboratory Director for Quality and Safety

About the Role:

This is an exciting opportunity to join Parachute LLC as a Laboratory Director, leading medical guidance and support to Physician Substitutes while ensuring the Donor Center meets all regulatory requirements. As the primary contact for health departments and regulatory agencies, you will be responsible for maintaining compliance with CLIA regulations.

Key Responsibilities:
  1. Medical and Laboratory Leadership:
    • Lead and manage medical and laboratory operations, ensuring high standards of care and compliance.
    • Serve as primary contact for health departments and regulatory agencies, ensuring procedures meet CLIA regulations.
    • Monitor donor suitability, safety, and product quality, providing valuable insights to enhance operations.
  2. Staff Training and Development:
    • Empower and equip medical staff with necessary training and certifications, fostering a culture of continuous learning and excellence.
    • Provide compassionate guidance during challenging donor reactions and support in confidential counseling for those with concerning test results.
  3. Commitment to Quality:
    • Establish and maintain a quality-focused approach to laboratory testing, ensuring accuracy and reliability in every aspect.
    • Regularly review quality assurance reports and test results, ensuring procedures are followed meticulously.
    • Create a safe and supportive laboratory environment, meeting all physical and environmental standards.
  4. Regulatory and Safety Assurance:
    • Ensure compliance with relevant regulations, including 21 CFR 630.3(i) and 21 CFR 630.5, safeguarding both donors and staff.
    • Manage donor counseling, testing, and follow-up care with a focus on safety and well-being.
  5. Collaborative Communication:
    • Offer constructive feedback to Center Operations Management and Quality Assurance team, working together to continually improve processes.
    • Participate in senior leadership meetings, contributing expertise to guide the Center's success.
Estimated Salary:

$150 per hour



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