Classification: Part-time Independent Contractor (Glassboro & Cherry Hill Locations)
Reports to: Director of Operations
PURPOSE
General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure the facility is in compliance with all applicable state, federal, consignees, and ABO designated regulations. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with the Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
CENTER MEDICAL DIRECTOR:
• Perform History and Physical Exams on Applicant Donors.
• Perform Repeat History and Physical exams on an annual basis on qualified donors.
• Explain process of Plasmapheresis.
• Obtain signed consent for Plasmapheresis.
• Explain all risks involved in Plasmapheresis.
• Monitor all reception area personnel in regard to donor acceptability and Total Protein requirements.
• Counsel donors with positive test results.
• Review SPE results.
• Monitor Physician Substitute(s) if applicable.
• Perform Monthly Reviews of Physician Substitutes (observe physical examination).
• Review applicable Donor Records of Physical Examinations and Laboratory tests approved by Physician Substitutes.
• Review all Abnormal SPE results.
• Review all donor adverse reactions.
• Review and approve all new and revised SOP procedures prior to release.
• Help establish Emergency procedures for the center.
• Available (on call) to provide assistance if center staff have questions or need guidance in handling of emergencies.
• Responsible for the continuous application of the Quality Assurance procedures to determine
donor suitability and collection of whole blood (if applicable) and plasmapheresis within the facility.
• Must be readily available if immunizations are being performed and/or within 15 minutes if Facility is licensed for specialty programs.
• Review SOP, cGMP regulations, and company policies on an annual basis.
• Responsible for Training of Physician Substitute(s).
• Participate in the QA audit meetings one time per month.
• Work in conjunction with Management.
• Perform other duties as requested by Management, such as in-service classes.
• Any other duties as assigned.
LABORATORY DIRECTOR:
The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurately, and proficiently and for assuring compliance with the applicable regulations.
a) The laboratory director, if qualified, may perform the duties of the technical
b) consultant, clinical consultant, and testing personnel, or delegate these
c) responsibilities to personnel meeting the qualifications of §§ 493.1409, 493.1415,
d) and 493.1421, respectively.
e) If the laboratory director reapportions performance of his or her
f) responsibilities, he or she remains responsible for ensuring that all duties are
g) properly performed.
h) The laboratory director must be accessible to the laboratory to provide onsite,
i) telephone or electronic consultation as needed.
j) Each individual may direct no more than five laboratories.
k) The laboratory director must—
1. Ensure that testing systems developed and used for each of the tests performed in
the laboratory provide quality laboratory services for all aspects of test performance, which
includes the preanalytic, analytic, and post-analytic phases of testing;
2. Ensure that the physical plant and environmental conditions of the laboratory are appropriate
for the testing performed and provide a safe environment in which employees are protected
from physical, chemical, and biological hazards;
3. Ensure that—
(i) The test methodologies selected have the capability of providing the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and
(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results;
4. Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that—
(i) The proficiency testing samples are tested as required under subpart H of this part;
(ii) The results are returned within the timeframes established by the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory;
5. Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;
6. Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;
7. Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance specifications are identified, and that patient test results are reported only when the system is functioning properly;
8. Ensure that reports of test results include pertinent information required for interpretation;
9. Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions;
10. Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise, and accurately perform tests and report test results in accordance with the personnel's responsibilities described in this subpart;
11. Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;
12. Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and post-analytical phases of testing to ensure that they are competent and maintain their competency to process specimens, perform test procedures, and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills;
13. Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and
14. Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and post-analytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results.
REQUIREMENTS
• Licensed to practice medicine in the assigned State
• Current CPR card
• Knowledgeable to handle all donor reactions or emergency situations
• Ability to teach other medical staff members and monitor their work performance
• Perform all tasks in a professional manner
• Ability to document information in a concise legible manner
• Work as a Team Member
• Assist in all inspections when needed
• Follow direction of Manager and or Q.A. Manager
• Participate in all Training and Job development meetings
• Perform and carry out all requirements as noted in section B (Donor Management) of the SOP
• Perform and carry out all requirements noted in SOP for Specialty Programs
• Will need to complete training and annual reviews as needed for employment, and to meet regulatory requirements
PHYSICAL DEMANDS
Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools, or controls, and to reach with the hands and arms. Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for short periods of time. Ability to read and type while sitting in front of a computer. Physically able to use and operate equipment used in assessing donor suitability. Ability to lift tug and pull up to 25 pounds.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. May be exposed to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment is required such as eyewear, lab coats, and gloves.
Classification: Part-time Independent Contractor (Glassboro & Cherry Hill Locations)
Reports to: Director of Operations
PURPOSE
General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure the facility is in compliance with all applicable state, federal, consignees, and ABO designated regulations. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with the Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
CENTER MEDICAL DIRECTOR:
• Perform History and Physical Exams on Applicant Donors.
• Perform Repeat History and Physical exams on an annual basis on qualified donors.
• Explain process of Plasmapheresis.
• Obtain signed consent for Plasmapheresis.
• Explain all risks involved in Plasmapheresis.
• Monitor all reception area personnel in regard to donor acceptability and Total Protein requirements.
• Counsel donors with positive test results.
• Review SPE results.
• Monitor Physician Substitute(s) if applicable.
• Perform Monthly Reviews of Physician Substitutes (observe physical examination).
• Review applicable Donor Records of Physical Examinations and Laboratory tests approved by Physician Substitutes.
• Review all Abnormal SPE results.
• Review all donor adverse reactions.
• Review and approve all new and revised SOP procedures prior to release.
• Help establish Emergency procedures for the center.
• Available (on call) to provide assistance if center staff have questions or need guidance in handling of emergencies.
• Responsible for the continuous application of the Quality Assurance procedures to determine
donor suitability and collection of whole blood (if applicable) and plasmapheresis within the facility.
• Must be readily available if immunizations are being performed and/or within 15 minutes if Facility is licensed for specialty programs.
• Review SOP, cGMP regulations, and company policies on an annual basis.
• Responsible for Training of Physician Substitute(s).
• Participate in the QA audit meetings one time per month.
• Work in conjunction with Management.
• Perform other duties as requested by Management, such as in-service classes.
• Any other duties as assigned.
LABORATORY DIRECTOR:
The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurately, and proficiently and for assuring compliance with the applicable regulations.
a) The laboratory director, if qualified, may perform the duties of the technical
b) consultant, clinical consultant, and testing personnel, or delegate these
c) responsibilities to personnel meeting the qualifications of §§ 493.1409, 493.1415,
d) and 493.1421, respectively.
e) If the laboratory director reapportions performance of his or her
f) responsibilities, he or she remains responsible for ensuring that all duties are
g) properly performed.
h) The laboratory director must be accessible to the laboratory to provide onsite,
i) telephone or electronic consultation as needed.
j) Each individual may direct no more than five laboratories.
k) The laboratory director must—
1. Ensure that testing systems developed and used for each of the tests performed in
the laboratory provide quality laboratory services for all aspects of test performance, which
includes the preanalytic, analytic, and post-analytic phases of testing;
2. Ensure that the physical plant and environmental conditions of the laboratory are appropriate
for the testing performed and provide a safe environment in which employees are protected
from physical, chemical, and biological hazards;
3. Ensure that—
(i) The test methodologies selected have the capability of providing the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and
(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results;
4. Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that—
(i) The proficiency testing samples are tested as required under subpart H of this part;
(ii) The results are returned within the timeframes established by the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory;
5. Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;
6. Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;
7. Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance specifications are identified, and that patient test results are reported only when the system is functioning properly;
8. Ensure that reports of test results include pertinent information required for interpretation;
9. Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions;
10. Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise, and accurately perform tests and report test results in accordance with the personnel's responsibilities described in this subpart;
11. Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;
12. Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and post-analytical phases of testing to ensure that they are competent and maintain their competency to process specimens, perform test procedures, and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills;
13. Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and
14. Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and post-analytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results.
REQUIREMENTS
• Licensed to practice medicine in the assigned State
• Current CPR card
• Knowledgeable to handle all donor reactions or emergency situations
• Ability to teach other medical staff members and monitor their work performance
• Perform all tasks in a professional manner
• Ability to document information in a concise legible manner
• Work as a Team Member
• Assist in all inspections when needed
• Follow direction of Manager and or Q.A. Manager
• Participate in all Training and Job development meetings
• Perform and carry out all requirements as noted in section B (Donor Management) of the SOP
• Perform and carry out all requirements noted in SOP for Specialty Programs
• Will need to complete training and annual reviews as needed for employment, and to meet regulatory requirements
PHYSICAL DEMANDS
Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools, or controls, and to reach with the hands and arms. Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for short periods of time. Ability to read and type while sitting in front of a computer. Physically able to use and operate equipment used in assessing donor suitability. Ability to lift tug and pull up to 25 pounds.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. May be exposed to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment is required such as eyewear, lab coats, and gloves.
PURPOSE
Ensure suitability of plasmapheresis donors, through the use of the SOP, current FDA and State guidelines, OSHA, CLIA, cGMP, and all internal company procedures.
General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
Perform History and Physical Exams on all applicant donors to assess donor suitability.Perform Repeat History and Physical exams on an annual basis of qualified donors.Explain process of Plasmapheresis.Obtain signed consent for Plasmapheresis.Explain all risk involved in Plasmapheresis.Evaluate donor reactions and initiate appropriate therapy.Initiate emergency medical procedures as needed, per standing orders of the physician.Notify physician of all emergencies.Serve as a liaison between the center and medical facilities and physician.Review the donor’s accumulated lab data/test result and collection records as required to determine the donor’s continued suitability.Provide appropriate and confidential counseling to ineligible donor candidates.Counsel donors with positive test results and confirmed positive test results.Maintain both donor and personnel confidentiality.Review normal SPE test results.Review and check donors with weight loss as needed.Perform periodic checks of donor floor to observe donors during plasmapheresis process.Function as a member of Quality Assurance team which monitors employee performance of screening and collection procedures.Participate in employee safety, education and training programs.Provide first aid for employee injuries.Monitor emergency medical supplies on a monthly basis.Must be trained at minimum in donor screening after 3 months from Physician Substitute certification.Once certified, assist in reception area, donor floor and plasma processing as needed or directed by the center manager.Assist with management and administration of employee counseling, testing and follow-up of employee exposures to plasma or blood.Determine Hematocrit (HCT) and Protein (CA Centers RN only performs) via finger stick and use of the hematastat and refractometer.Perform Proficiency Testing - (CA Centers RN only performs).Perform Statistical Analysis of Total Protein Results (CA Centers RN only performs).Perform daily controls.Perform monthly statistical analysis.Perform periodic Accu-Test (CA Centers RN only performs).Perform Calibration of machines as needed.
Reporting and Accountability
Consult with Medical Director as necessary regarding donor suitability and treatment of donor reactions.Consult with Medical Director as necessary regarding medications not listed in Medication Handbook.Unusual medical problems, especially those involving donor selection and health, and both donor and employee safety, are to be brought to the attention of the Medical Director as soon as possible.Duties and performance are subject to periodic review by Medical Director, QA Manager, and Corporate QA department.Responsible for product safety by selecting only healthy donors, and for donor safety assuring that procedures are correctly performed.Responsible for providing coverage for all the hours of operation that they are scheduled. This individual is responsible for finding an appropriate substitute if they cannot cover the hours.Must read, understand and comply with all federal, state and local regulations.Other Responsibilities
Will make decisions regarding donor suitability, based on broad medical knowledge, familiarity with the current SOP and all applicable regulations to plasmapheresis.Will evaluate donor reaction regarding type, severity, and appropriate treatment methods.Consult with the medical director whenever an unusual problem occurs.Will notify management if the center is operating outside of the standard operating procedures to prevent a detrimental impact on the donor, employees or product.Will appraise new procedures and equipment for impact on donor, employee and product safety.Provide oversight for Reception area.Perform ancillary duties and act as a support person for the reception area, donor floor or plasma area.Review SOP, cGMP regulations, and company policies on annual basis.Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.Any other duties as assigned.REQUIREMENTS
Must be graduate of recognized educational program and be currently licensed in the state they are employed.Physician Substitute – EMT: Must be EMT basic or abovePhysician Substitute – RN: Only RN’s or Licensed Physician Assistants may hold this positionPhysician Substitute – LVN/LPN: Licensed LVN or LPNIndividual must meet and maintain current licensing requirement in the state they are employed and company with federal, state and local regulations.Must maintain current certification in CPRMust complete our training program for Physician’s Substitute/Physician Assistant under the supervision of the Center’s Medical Director, and additional programs when deemed necessaryProficient with computer entryMinimum requirement is additionally certified in Donor Screening. Phlebotomy and Plasma Processing certification may be required by managementMay be required to travel for trainingMust be proficient in English (Read, Write, Speak).PHYSICAL DEMANDS
Performing the responsibilities of the job requires ability to talk and hear. Regularly required use hands and fingers, handle, or feel objects, tools or controls, and reach with the hands and arms. Frequently required to stand, for extended period of time (2–3-hour intervals), walk, climb or balance; and stoop, kneel, or crouch. Ability to read and type while sitting in front of a computer. Physically able to use and operate equipment used in assessing donor suitability as well as equipment used to harvest plasma. Manual dexterity to perform all phases of plasmapheresis. Ability to lift tug and pull up to 50 pounds.
WORK ENVIRONMENT
This job routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Occupational exposure to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as eyewear, lab coats, and gloves.
PURPOSE
Operate the automated plasmapheresis machines, monitor donors, and ensure that donors experience a safe and successful plasmapheresis procedure.
General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
Set up and operate instruments used for donor qualification and donation;Perform all necessary steps for successfully harvesting Source Plasma.Perform arm scrub in accordance with SOP.Perform phlebotomy.Assist in determining donor vein suitability.Monitor donors and equipment operation to ensure health of donor and quality of product.Ensure and maintain accurate and thorough documentation of necessary records as required by SOPs.Build rapport with donors to ensure overall customer satisfaction with center and encourage return visits.Ensure accurate and thorough documentation in NexLynk and necessary records as required by SOP.Prepare bleach solutions and other disinfectant solutions as required.Clean and perform daily, weekly and monthly maintenance of PCS2.Ensure proper cleaning of equipment and supplies to prevent cross contamination.Clean beds, carts and/or other equipment on donor floor.Log and stock incoming supplies as needed.Ensure donor confidentiality is maintained.Maintain instruments used for donor qualification and donation;Document operational and maintenance activities;Assess supply inventory; order and restock, as needed;Attend to donor’s needs, including donor reactions.Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.Any other duties as assigned.REQUIREMENTS
High school diploma or equivalent (Must be able to show proof)Phlebotomy certification from an accredited institution is preferredStrong customer service skills.Must be proficient in English (Read, Write, Speak) with legible handwritingCurrent CPR cardProficient with computer entryMay be required to travel for trainingPHYSICAL DEMANDS
Performing the responsibilities of the job requires ability to talk and hear. Regularly required to use hands and fingers, to handle & feel objects, tools and controls; reach with hands and arms. Vision abilities required by this job include close vision. Required to stand for extended intervals, walk, climb and balance; stoop, kneel and crouch. Physical ability to operate equipment used on donor floor areas that may require repetitive motion and manual dexterity. Ability to lift, tug, and pull up to 50 pounds. Ability to read while standing or sitting in front of a computer for short periods of time.
WORK ENVIRONMENT
This job routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Occupational exposure to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as eyewear, lab coats, and gloves.
PURPOSE
Operates under the direct supervision Operations Supervisor. Follows and adheres to buyer specifications. Ensure there are no out-of-compliance conditions when processing the plasma or samples. Complete tasks accurately and in compliance, to set the example for employees under their lead.
General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
Ensure product integrity by ensuring compliance with Food and Drug Administration (FDA) regulations, state regulations, ABO’s Standard Operating Procedures (SOP), and any other applicable regulatory standards.Organize product in storage freezer, ensuring freezer organization is complete and consistent.Perform the QA review of donor samples.Perform the QA review of product to be shipped to the consignee.Assist with the process flow in the lab, ensuring the bottles are entering the freezer in the proper time frame.Coordinate Daily Activities in Processing AreaMake daily assignment in coordination with managerProvide preventive maintenance as scheduled on equipment: centrifuge, heat sealers, thermometer, internal freezer thermometers and graph recorders, and calibrate as necessaryObserve technicians for complianceAssist with destroying unacceptable units. Quarantine and discard unacceptable samples and products.Manage flow of units coming through the window and ensure compliance in accordance with the SOP.Facilitate training of new lab team members in coordination.Set up, operate and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control).Maintain instruments used for processing and storage of donor samples and products.Document operational and maintenance activities when necessary.Determine supply inventory requirements; order and restock, as needed.Communicate delays and other issues to center management, and/or other necessary parties.Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.Any other duties as assigned.REQUIREMENTS
High school diploma or equivalent (Must be able to show proof)Strong customer service skills.Must be proficient in English (Read, Write, Speak) with legible handwritingCurrent CPR cardProficient with computer entryPrior supervisory skills preferredCertified as a TrainerSix months’ experience in plasma processing (Requirements can be changed by Management, depending on knowledge, skills and abilities.)May be required to travel for trainingPHYSICAL DEMANDS
Performing the responsibilities of the job requires ability to use hands and fingers to handle and feel objects, tools or controls; reach with hands and arms. Frequently required to stand, walk, climb and balance; and stoop, kneel, or crouch. Required to stand for extended periods of time (2-4 hour intervals). Ability to lift, tug, and pull up to 50 pounds.
WORK ENVIRONMENT
This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May be exposed to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as protective eyewear, lab coat, gloves and freezer jacket/gloves/pants. Work in a walk-in freezer for short intervals of time (-20C or colder).
PURPOSE
Responsible for conducting a series of screening procedures to determine suitability for plasma donation. Screening procedures may include reviewing health-related documents and taking vital signs including blood pressure, pulse, and temperature.
General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
Administer health history questionnaire to new and repeat donors, as applicableManage donor flow throughout the centerCommunicate delays and other issues to center management, nurse, and/or other necessary partiesDocument activities when necessarySet up and operate instruments used for the testing of donor vitals and other station equipmentAssess donor weight and vital recordsEnsure the area is clean and maintained according to regulationsRefill supplies and clean machines/station at the conclusion of the shiftAnswer donor inquiriesAdhere to all company policies, procedures, and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.Any other duties as assigned.REQUIREMENTS
High school diploma or equivalent (Must be able to show proof)Strong customer service skills.Must be proficient in English (Read, Write, Speak) with legible handwritingCurrent CPR cardProficient with computer entryMay be required to travel for trainingPHYSICAL DEMANDS
Performing the responsibilities of the job requires the ability to talk and hear. Regularly required to use hands and fingers, to handle & feel objects, tools, and controls; reach with hands and arms. Vision abilities required by this job include close vision. Required to stand for extended intervals, walk, climb and balance; stoop, kneel and crouch. Physical ability to operate equipment used in screening and donor floor areas that may require repetitive motions and manual dexterity. Ability to lift, tug, and pull up to 50 pounds. Ability to read while standing or sitting in front of a computer for short periods of time.
WORK ENVIRONMENT
This job routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Occupational exposure to bloodborne pathogens and other conditions are common to a donor center. Personal protective equipment required such as eyewear, lab coats, and gloves.
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