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 the Food and Drug Administration (FDA).
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...
Sep 01, 2020
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 the Food and Drug Administration (FDA).
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...
Responsible for preparing the donor, donor area and equipment for the pheresis process.
Main Responsibilities
1. Prepares the autopheresis machine for the pheresis process. 2. Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. 3. Disconnects the donor when the process is complete. 4. Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff. 5. Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. 6. Uses PDA to link equipment and soft goods used in the pheresis process to the appropriate donor. 7. Alerts Group Leader or Supervisor of donor flow issues. 8. Ensures the accurate recording of donor data in the electronic donor information...
Sep 01, 2020
Responsible for preparing the donor, donor area and equipment for the pheresis process.
Main Responsibilities
1. Prepares the autopheresis machine for the pheresis process. 2. Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. 3. Disconnects the donor when the process is complete. 4. Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff. 5. Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. 6. Uses PDA to link equipment and soft goods used in the pheresis process to the appropriate donor. 7. Alerts Group Leader or Supervisor of donor flow issues. 8. Ensures the accurate recording of donor data in the electronic donor information...
Responsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process.
1 In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor’s hematocrit and total protein levels. 2 Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center...
Sep 01, 2020
Responsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process.
1 In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor’s hematocrit and total protein levels. 2 Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center...
Responsible for the evaluation of donor suitability for automated pheresis procedures. Administration and supervision of approved immunizations other than red blood cell immunizations. Provides limited emergency medical care to donors and staff, including the administration of medication or treatments in accordance with licensure or certification.
1 Promotes positive customer relations with all donors. 2 Conducts confidential and effective interviews with donors to obtain necessary information regarding suitability to donate plasma. 3 In conjunction with the Center Medical Director and/or Center Physician responds to medically related questions from staff including donor suitability and provides information to staff on medically related issues. 4 Performs medical history reviews and health assessments on donors. Assesses results of donor screening and laboratory tests to determine initial and continuing donor suitability. 5 Notifies and counsels donors regarding reactive test...
Sep 01, 2020
Responsible for the evaluation of donor suitability for automated pheresis procedures. Administration and supervision of approved immunizations other than red blood cell immunizations. Provides limited emergency medical care to donors and staff, including the administration of medication or treatments in accordance with licensure or certification.
1 Promotes positive customer relations with all donors. 2 Conducts confidential and effective interviews with donors to obtain necessary information regarding suitability to donate plasma. 3 In conjunction with the Center Medical Director and/or Center Physician responds to medically related questions from staff including donor suitability and provides information to staff on medically related issues. 4 Performs medical history reviews and health assessments on donors. Assesses results of donor screening and laboratory tests to determine initial and continuing donor suitability. 5 Notifies and counsels donors regarding reactive test...
Responsible for the efficient and effective collection of plasma from donors by performing venipuncture, monitoring the pheresis process and following Standard Operating Procedures (SOPs).
1 In compliance with SOPs, performs all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect. 2 In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process. 3 Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor. 4 May educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees,...
Sep 01, 2020
Responsible for the efficient and effective collection of plasma from donors by performing venipuncture, monitoring the pheresis process and following Standard Operating Procedures (SOPs).
1 In compliance with SOPs, performs all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect. 2 In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process. 3 Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor. 4 May educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees,...
This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.
• Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level
1 Perform...
Sep 01, 2020
This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.
• Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level
1 Perform...
Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors.
1 In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. 2 Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. 3 Ensures accuracy of unit labeling by verifying the pre-printed label matches the dynamic label. 4 Utilizes sterile technique to draw samples and uses heat sealer to assure the sterility and quality of plasma unit samples per SOPs. 5 May ensure samples and units are packed and shipped in accordance with SOPs and center procedures. Prepares shipping and unit disposal documentation. 6 Monitors freezer and refrigerator temperatures and immediately informs appropriate personnel if equipment is not functioning properly. Records variances. 7 Conducts daily calibration of equipment according to...
Sep 01, 2020
Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors.
1 In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. 2 Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. 3 Ensures accuracy of unit labeling by verifying the pre-printed label matches the dynamic label. 4 Utilizes sterile technique to draw samples and uses heat sealer to assure the sterility and quality of plasma unit samples per SOPs. 5 May ensure samples and units are packed and shipped in accordance with SOPs and center procedures. Prepares shipping and unit disposal documentation. 6 Monitors freezer and refrigerator temperatures and immediately informs appropriate personnel if equipment is not functioning properly. Records variances. 7 Conducts daily calibration of equipment according to...
