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Purpose
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.
Key Accountabilities
1. Observes and approves Medical Supervisor annual recertification.
2. Reviews the donor’s accumulated laboratory data and collection records as required in 21 CFR 640.65 to determine the donor’s continued suitability.
3. Signs abnormal SPE/RPR Test Profiles and review all other abnormal laboratory test results on a weekly basis.
4. Determines the status of donor suitability for donors with abnormal laboratory test results.
5. Reviews 10% of the weekly SPE/RPR Test Profiles completed by each Medical Supervisor for the DRF Medical Review.
6. Reviews 10% of the Medical Qualifications performed weekly by each Medical Supervisor.
7. 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.
8. The physician will always be on the premises while donor red cell stimulation procedures are being performed.
9. 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.
10. 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.
11. Centers with Immunization Programs:
a. 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.
Qualifications
1. Must be licensed to practice medicine in the state in which he or she will be working in the Plasma Center. May be either an M.D. or D.O. The license must be kept up to date and the current license provided to the plasma center manager.
2. Must have previous experience working on a desk top computer as well as experience logging into and out of a secure computer system.
3. Must have proficient knowledge of using Microsoft Office, Outlook and Internet Explorer.
4. Must also be proficient in navigating a patient database (i.e CTMS, EMRs or DMSs).
Physical and Mental Working Conditions
1. Frequently performs work while sitting.
2. Frequently exposed to bloodborne pathogens and may be required to wear personal protective equipment.
3. Be available by phone for consultation on donor suitability and medical emergencies.
About Us
BPL Plasma is a global leader in the collection of human plasma used in the manufacture of life-saving therapies for patients world-wide. We are a Quality First organization and committed to excellence when it comes to collecting plasma and taking care of our donors. Lives depend on the work we do.
The Team
Headquartered in Austin, Texas, we are growing company of more than 2000 teammates located in more than 25 cities across the United States.
The Benefits
- Advancement opportunities
- Flexible work schedule
- Fun and fast paced environment
- Health and Welfare Insurance with competitive employee contributions
- Basic Life, Short and Long-Term Disability Insurance
- 401(k) Retirement Plan with company match
Job Types: Part-time, Contract
Pay: $170.00 per hour
Education:
- Doctorate (Required)
License/Certification:
- BLS Certification (Required)
- Medical License (Required)
Willingness to travel:
- 25% (Preferred)
Work Location: One location