Licensed Physican- Contracted

Octapharma Plasma; Audubon (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

Octapharma Plasma is seeking a Contracted Licensed Physician to oversee donor safety and medical judgment for plasmapheresis and immunization. The role includes supervising physician substitutes, ensuring regulatory compliance, and providing on-site or remote consultations for donor eligibility.

The ideal candidate will have a medical license in the operating state and experience with SOPs, FDA/OSHA/CLIA standards, and cGMP practices, including consent administration and donor history assessment.

Qualifications

• Must be a graduate from a licensed medical or osteopathic school.
• Must hold a current medical license in the state where the center operates.
• Must be approved by the state licensing agency as the CLIA Laboratory Director, Clinical Consultant, and Technical Consultant for the donor center, as applicable.

Responsibilities

• Provide independent medical judgment regarding donor safety and suitability for plasmapheresis and/or immunization.
• Supervise physician substitutes and ensure donor questions are addressed.
• Select suitable plasmapheresis donors according to SOPs and regulatory requirements (FDA, OSHA, CLIA, cGMP).
• Provide on-site, telephone, or electronic consultation regarding donor eligibility.
• Explain informed consent for plasmapheresis and immunization in compliance with federal regulations.
• Oversee physical examinations and confirm donor eligibility promptly.
• Provide oversight to assess unusual or severe donor reactions with appropriate medical judgment.
• Deliver mandated training for donor center medical staff, including Physician Substitutes and Alternate Physicians.
• Review abnormal lab results to determine future donation eligibility.

Education

Graduate from licensed medical or osteopathic school

Current medical license in operating state

CLIA Laboratory Director/Clinical Consultant/Technical Consultant approval

Job description

JOB DESCRIPTION – Contracted Licensed Physician

ESSENTIAL JOB FUNCTIONS:

To provide independent medical judgment and discretion regarding donor safety, health, and suitability for plasmapheresis and/or immunization. The ideal candidate will demonstrate the ability to supervise medical staff and ensure compliance with federal and international regulations, as well as internal standard operating procedures.

• Donor Interaction
• Ensure donor satisfaction through oversight of physician substitute interactions and responsiveness to donor needs.
• Select suitable plasmapheresis donors according to medical education, experience, and compliance with Standard Operating Procedures (SOP), FDA, OSHA, Clinical Laboratory Improvement Amendments (CLIA), and current Good Manufacturing Practices (cGMP), including informed consent administration and medical history assessment.
• Consultation Availability
• Provide on-site, telephone, or electronic consultation regarding donor eligibility.
• Ensure detailed explanations of informed consents for plasmapheresis and immunization are provided to donors in compliance with applicable federal regulations.
• Donor Inquiry Response
• Supervise physician substitutes in addressing donor questions and ensuring that donors are given a clear opportunity to refuse participation.
• Physical Examinations
• Oversee the performance of physical examinations and analyze accumulated data to confirm established donor eligibility promptly.
• Medical Oversight
• Provide oversight to ensure that physician substitutes assess unusual or severe donor reactions with appropriate medical judgment.
• Training Requirements
• Deliver federal and internationally mandated training for donor center medical staff, including Physician Substitutes and Alternate Physicians. Management of Donor Reactions
• Exercise medical judgment to assess donor reactions and implement appropriate management procedures in line with current SOPs.
• Confidential Counseling
• Ensure that confidential counseling is provided to unacceptable donors, when applicable.
• Review unusual or abnormal lab results, exercising independent judgment to determine future eligibility for donation. Service Delivery:
• Determine the method and means for the performance of contracted services in accordance with applicable

regulations and client requirements.

Education Specifications

• Must be a graduate from a licensed medical or osteopathic school.
• Must hold a current medical license in the state where the center operates.
• Must be approved by the state licensing agency as the CLIA Laboratory Director, Clinical Consultant, and Technical Consultant for the donor center, as applicable.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.