Center Medical and Laboratory Director

4 weeks ago

Laredo, Texas, United States Biomat USA Full time

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909.

We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions.

Job Title:

Center Medical and Laboratory Director

The Center Medical and Laboratory Director works under the supervision of the Division Medical Director for professional competency matters and the Center Management for administrative matters.

It is their responsibility to follow and be compliant with the guidelines and regulations of the Food and Drug Administration (FDA) and the company's Standard Operating Procedures (SOP), and all applicable regulatory agencies to ensure proper donor assessment in regards to their suitability as a plasma donor and product integrity.

Primary Responsibilities:

  • Serves as recognized Center Medical and Laboratory Director for all verbal and/or written correspondence to state Department(s) of Health and other regulatory agencies related to their assigned donor center(s), as required.
  • Promote customer satisfaction through appropriate interaction and responsiveness to customer needs.
  • Observe and confirm compliance of the Center's medical and laboratory procedures as they affect the safety of the donors and the final product; and provide feedback to Facility Management Team.
  • Selection of suitable plasmapheresis donors by performing physical examinations and taking medical and social histories on all donors, and through the use of the company's FDA approved Standard Operating Procedure manual, current State and Federal guidelines, OSHA, CLIA, cGMP, pertinent sections of the CFR, all internal company procedures as well as personal education and experience.
  • Timely review of accumulated data to confirm established donor suitability, donor safety and product safety.
  • Oversee and assist in the certification, training and performance of the center medical staff and center physicians (as applicable) as it pertains to the donor assessment and to compliance with the Company's standard operating procedures (SOP).
  • Provide additional necessary training, re-certification and corrective actions for the center's Medical Staff.
  • Provide guidance and certification of the center's medical staff regarding:
  • a) the appropriate and confidential counseling to individuals with unacceptable test results, and
  • b) the appropriate level of care during unusual or severe donor reactions.
  • Provide appropriate and confidential counseling to unacceptable individuals and to individuals with abnormal test results.
  • Provide appropriate level of care during unusual or severe donor reactions.
  • Management, training, administration and/or supervision of all approved donor immunization programs, if available at the center, according to established protocol.
  • Recommend changes and improvements to Standard Operating Procedures.
  • Assist with management and administration of donor counseling, testing, and follow up of employee exposure to blood or plasma.
  • Assist or manage the employee immunization program.
  • Learn, understand and be independent working with the Donor Management System (DMS) as it relates to the duties and responsibilities of this position.
  • Participate and collaborate with center's CLIA, Safety, Quality meetings and other meetings as necessary.
  • Provide education sessions to the medical staff according to the Company's standard operating procedures (SOP).
  • Review and approve the CLIA-defined moderate complexity test procedures, as required.
  • Act as Technical and Clinical Consultant for all CLIA regulated testing in compliance with the responsibilities outlined in 42 CFR, Part 493, Laboratory Requirements, Subpart M, Sections and , Standards; Technical Consultant and Clinical Consultant responsibilities.
  • Complete the CLIA competency assessment for all employees who perform CLIA designated moderate complexity tests according to regulatory guidelines.
  • Review the QA reports for timely and appropriate actions on moderate complexity procedures for test problems.
  • Review results of moderate complexity tests and proficiency testing by the plasma center staff as required.
  • As requested, provide a copy of the current medical license, curriculum Vitae, diplomas, and other documents to fulfill State, Federal and company requirements.
  • Meet monthly with the Division Medical Director.
  • Other duties as assigned.

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