The Opportunity
Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the primary center physician registered as the Laboratory Director with CLIA.
You will report directly to the Center Manager, with dotted line reporting to the Division Medical Director.
The Role
• Serves as the primary physician for reporting to the Food and Drug Administration, in such capacity provides medical oversight in compliance with applicable Federal and State regulations including the applicable sections of Title 21 of the Code of Federal Regulations, and monitors medical compliance of the center.
• Either serves as or delegates to another appropriate physician the duties of “laboratory director”, “technical consultant”, or “clinical consultant” as prescribed by the Clinical Laboratory Improvement Act of 1988 regulations (CLIA). May be required to provide direct oversight of total protein testing.
• Reviews, understands, and complies with all CSL Plasma Services policies and procedures in the performance of services. Maintains high medical standards and ensures that cGMPs are adhered to through involvement with center management, center quality unit, and overall center activities. Is physically present in the center for designated work schedules.
• Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate and observes MSAs periodically. Functionally directs the Center Medical Staff. Provides training to other center staff on medically related procedures and practices.
• Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting. May serves as a member of the Quality Assurance Team. Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff.
• Responds to inquiries regarding donor suitability for plasmapheresis. Responds to calls from and provides instruction to Center Medical Staff with donor suitability questions. Conducts confidential and effective interviews with donors to obtain information in a variety of situations. Interviews donors with positive STS/negative FTA and
documents approval to resume donating.
• Maintains confidentiality with respect to employee, donor and center records reviewed during the course of all duties. Responsible for overseeing maintenance of medical supplies and other emergency equipment.
• Reviews and signs moderate and severe medical incident reports prior to donor being permitted to resume donating. Reviews abnormal test results including abnormal protein electrophoresis (PE) test results and donor record files. Reviews normal PE test results following an abnormal one and documents approval to resume donating.
• Assures the health and safety of donors participating in the non-red blood cell immunization programs, if applicable. Monitors donor clinical response to immunizations, when applicable. Oversees hyper-immune programs, if applicable.
• For red cell recipients in the Anti-D Program, if applicable: Performs qualifying evaluation (e.g. administers consents, medical history and physical exam) on donors before enrollment; provides review and approval for red blood cell immunization; is present when red cell immunizations are given.
• Determines donor suitability following donor adverse reactions (DAE). Maintains current knowledge of infectious disease markers (i.e. HIV, HBV, HCV, syphilis, etc.).
• May perform Center Physician functions including but not limited to notifying donors of unsuitable test results, performing screening medical evaluations, assessing results of donor screening and laboratory tests to determine a donor’s initial and continued suitability for plasmapheresis, explaining informed consent materials to donors.
• May support Corporate Medical Operations with additional duties as and when requested by the company.
Your skills and experience
Education
• MD or DO degree from an accredited medical or osteopathic school.
• Must maintain a current and active medical license in the state in which the Center is located.
• If applicable for state regulations, must meet all state specific educational requirements.
Experience
• One year of residency training as an MD or OD.
• If applicable for state regulations, must meet all state specific experience requirements.
Additional Comments
Familiarity with Code of Federal Regulations (CFR) and all relevant procedures in the company Plasma Operating Procedures.
Working Conditions
(physical & mental requirements)
• Ability to make decisions which have significant impact on the department’s creditability, operations and services.
• Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations.
• Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens.
• Required to wear Personal Protective Equipment while performing specific tasks or in certain areas.
• Travel to multiple centers other than primary location may be required.
• Frequent standing and walking.
• Fast paced environment with frequent interruptions.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Plasma
CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Plasma!
