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Medical Director
1 month ago
Job Summary:
The Clinical Laboratory Director and Pathologist will play a vital role in ensuring the Donor Center meets all regulatory requirements and operates smoothly. This position is central to providing medical guidance and support to the Physician Substitutes while offering training as needed.
Key Responsibilities:
- Lead and manage the medical and laboratory operations, ensuring they are conducted with the highest standards of care and compliance.
- Serve as the primary contact for health departments and regulatory agencies, ensuring all procedures meet CLIA regulations.
- Monitor donor suitability, safety, and product quality, providing valuable insights to enhance operations.
- Empower and equip the medical staff with the necessary training and certifications, fostering a culture of continuous learning and excellence.
- Establish and maintain a quality-focused approach to laboratory testing, ensuring accuracy and reliability in every aspect.
- Create a safe and supportive laboratory environment, ensuring it meets all physical and environmental standards.
- Ensure compliance with all 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.
Qualifications:
- Doctor of Medicine, Osteopathy, or Podiatric Medicine with the appropriate state licenses.
- Certification in anatomic or clinical pathology is ideal, though equivalent qualifications will be considered.
- A minimum of one year directing or supervising laboratory testing, with a focus on quality and safety.
- Alternatively, 20 continuing medical education credits or equivalent laboratory training.
Work Environment:
This role involves frequent use of hands, fingers, and wrists, with some exposure to hazardous chemicals and bloodborne pathogens. Personal Protective Equipment (PPE) will be provided and required for specific tasks or areas.
In this role, you'll have the opportunity to make a meaningful impact on both the safety of our donors and the quality of our operations, all while working within a supportive and collaborative team environment.