Center Medical Director
Job Posting for Center Medical Director at BPL Plasma, Inc
Donor safety and welfare will be the primary consideration of the physician through donor history and physical examinations, informed consents, management of donor reactions, evaluation of laboratory results and immunizations. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
- Observes and approves Medical Supervisor annual recertification.
- Reviews the donor's accumulated laboratory data and collection records as required in 21 CFR 640.65 to determine the donor's continued suitability.
- Signs abnormal SPE/RPR Test Profiles and review all other abnormal laboratory test results on a weekly basis.
- Determines the status of donor suitability for donors with abnormal laboratory test results.
- Reviews 10% of the weekly SPE/RPR Test Profiles completed by each Medical Supervisor for the DRF Medical Review.
- Reviews 10% of the Medical Qualifications performed weekly by each Medical
Supervisor. - Complies with all facility SOPs, FDA and EU regulations, OSHA, CLIA and COLA requirements and properly document said compliance. The physician will be knowledgeable in CLIA Proficiency Testing requirements.
- The physician will always be on the premises while donor red cell stimulation procedures are being performed.
- Determines donor suitability when screening values fall into the borderline areas (e.g., elevated blood pressure, elevated pulse, weight loss) or when the donor has been absent from the plasmapheresis program for any length of time.
- Refers donors to other medical facilities or physicians as necessary (e.g., donors with infectious disease markers such as Anti-HCV, Anti-HIV 1/2, HBsAg, HIV-1 NAT or HCV NAT reactive test results) and serves as a liaison between the plasmapheresis facility and such medical facilities and physicians.
- Centers with Immunization Programs:
- Supervises or performs immunizations of donors in accordance with 21 CFR 640.66 and the SOP. The physician will evaluate donor adverse reactions to the immunizing agent and will evaluate donor reactions and responses to the immunization and initiate appropriate treatment for such reactions.
Salary.com Estimation for Center Medical Director in Flagstaff, AZ
$87,222 to $116,289
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