Medical Director Center
2 weeks ago
As a Medical Director at KEDPlasma USA, you will be responsible for ensuring the safety and welfare of donors through thorough medical evaluations, informed consents, and management of donor reactions. You will operate within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR, providing independent medical judgment and discretion for issues relating to donor safety, health, and suitability for plasmapheresis and/or immunization.
Main Duties and Responsibilities- Observe and approve Physician Substitute initial and/or annual recertification, reviewing the initial, at-months, and annual employee training for the performance of CLIA designated moderate complexity tests.
- Review the donor's accumulated laboratory data and collection records as required in 21 CFR to determine the donor's continued suitability.
- Review and approve abnormal SPE/RPR Test Profiles and review all other abnormal laboratory test results on a weekly basis.
- Determine the status of donor suitability for donors with abnormal laboratory test results.
- Review 10% of the weekly SPE/RPR Test Profiles completed by each Physician Substitute for the Medical Review as required.
- Comply with all facility SOPs, FDA and EU regulations, OSHA, PPTA, CLIA, and COLA requirements, and properly document said compliance.
- Ensure a Physician is present in the premises while donor red cell immunization procedures are being performed.
- Determine donor suitability when screening values fall into the borderline areas.
- Refer donors to other medical facilities or physicians as necessary and serve as a liaison between the plasmapheresis facility and such medical facilities and physicians.
- Assure donor satisfaction through appropriate physician interaction and responsiveness to donor needs.
- Observe staff, center activity, and practices, and communicate compliance issues to appropriate individuals when needed.
- Propose revisions to SOPs and Company practices when appropriate.
- Review and approve the CLIA defined moderate complexity test procedures.
- Select suitable plasmapheresis donors pursuant to the Physician's medical education and experience and in accordance with SOP, FDA, PPTA, OSHA, CLIA, cGMP by utilizing informed consent administration, assessing medical history, and administering physical examinations if applicable.
- Explain informed consents for plasmapheresis and immunization to donors based upon the Physician's judgment and discretion and in compliance with 21 CFR 630.5.
- Answer and discuss any donor questions and ensure the donor is given a clear opportunity to refuse participation.
- Provide appropriate level of care and medical judgment when assessing issues related to unusual or severe donor reactions.
- Exercise medical judgment by assessing donor situations and institute appropriate management procedures in accordance with current SOP and the center's standing orders.
- Administer and/or supervise administration of immunizations, order immunizations, and utilize medical expertise to analyze candidates and/or donor's reactions.
- Review the QC/QA/proficiency testing reports for timely and appropriate actions on moderate complexity procedures for test problems.
- Assure on-call availability to provide consultation on donor suitability and medical emergencies.
- Manage and oversee direct reports, discipline and terminate employees following approved company guidelines, establish and communicate performance standards, coach others for success, and recruit, interview, hire, and train employees as needed.
- Oversee work assignments, support and rearrange workload of direct reports, provide constructive and timely performance evaluations, motivate and evaluate employees based on established performance standards, promote staff retention, and receive, investigate, and respond to employee grievances.
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