Center Medical Director
Company: CSL Behring LTD
Location: Port Arthur
Posted on: June 24, 2022
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Job Description:
Job Description * Serves as the primary physician for reporting
to the Food and Drug Administration and 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). Assures that
CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit
and total protein, and signed of logs involving standardization
takes place.
* 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 at the center
for agreed upon hours.
* Provides medical oversight to Medical Staff Associates, including
their training, although such training may be delegated to an
approved Medical Staff Associate. Trains other physicians.
Evaluates newly trained Medical Staff Associates for completion of
training and recommendation for certification by Regulatory
Affairs. Functionally directs the Center Medical Staff. Provides
training to other center staff on medically related procedures and
practices.
* Reviews and signed Medical Staff Associates notebooks weekly,
including a review of approximately one out of five screening
medical evaluations and unsuitable test result communication.
* Meets with Medical Staff Associates at least once a month to
discuss medically related topics. Documents each meeting. Meets
with the Center Manager and Compliance Specialist (or designees)
during weekly visits to the center. 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, which
includes preparation of monthly reports and periodic conference
calls.
* Responds to questions and phone calls regarding donor suitability
for long-term serial 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 ad other
emergency equipment.
* Reviews and sings moderate and severe medical incident reports
prior to donor being permitted to resume donating. Reviews abnormal
test results including abnormal serum protein electrophoresis (SPE)
test results and donor record lc-PD-09195 Page 2 files. Reviews
normal SPE 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. Submits monthly report to Divisional (or Corporate) Medical
Director.
* Determines donor suitability following adverse reactions in
consultation with the Corporate or Divisional Medical Director.
Maintains current knowledge of infectious disease markets (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.
* Performs additional services as and when requested by the
company. Please note, we may not have an immediate need at the
present time; however we are always interested in speaking to well
qualified candidates for future openings. If you are interested in
exploring a career with CSL, please apply. We may have both
full-time and part-time positions available. Someone will follow up
depending on the current needs, but please be aware correspondence
may not be immediate. About Us 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 As a global organisation with employees
in 35+ countries, CSL embraces diversity, equity and inclusion.
Learn more about Diversity, Equity & Inclusion at CSL. Do work that
matters at CSL Plasma!
Keywords: CSL Behring LTD, Port Arthur , Center Medical Director, Executive , Port Arthur, Texas
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