Responsible for registering and screening donors under the direction of the Center Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.

Every effort has been made to make your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if the work is similar, related or is a logical assignment to the position.

Core

· Facilitates donor flow throughout the plasma collection center with a sense of urgency, minimizing

wait time by working carefully and efficiently.

· Registers applicant donors.

· Assists qualified donors in completing the screening process.

· Assesses the self-administered health history, refers donors to medical staff when appropriate and

performs health screening procedures such as blood pressure, pulse, weight, temperature.

· Performs finger sticks to obtain a sample to obtain hematocrit and total protein levels.

· Prepares equipment by performing PQ/calibrations and verifying required maintenance has been

performed as outlined in the SOP.

· Performs troubleshooting of equipment within scope of training.

· Performs Haemonetics Autopheresis setup and programming with understanding of alarm signals

during operation, shut down or in the event of power failure.

· Responds and resolves equipment alarms.

· Responds to donor issues related to collection.

· Notifies management or medical personnel if an alarm or donor issue requires needle adjustments

and/or resticks.

· Prepares collection machines for the plasmapheresis procedure and plasma collection, including

donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA

guidelines, as needed.

· Monitors the safety and care of the donor during the plasmapheresis process.

· Maintains alertness and awareness to any reaction a donor may have during or after the

plasmapheresis process and notifies appropriate medical staff.

· Ensures accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. · Records incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. · Maintains a clean, orderly, and efficient work environment and ensures sufficient operating supplies are available as needed. · Records any required documentation accurately and in compliance with company SOPs. · Maintains data integrity and confidentiality of all personnel, donor, and plasma collection center information. · Monitors donors for possible issues with their donation, understands how to handle donor adverse events and collection exceptions. · Explains plasma collection center policies & rules to new donors about the donation process, proper nutrition, and any other information pertinent to the donor or donor safety. · Works with plasma collection center’s staff to meet production goals. · Ensures all donor questions are answered timely, accurately, and professionally and alerts management of any issues or concerns. · Assists plasma collection center for audits. · Follows all SOPs and regulatory policies and procedures, including the employee handbook. · Remains current on SOPs changes. · Follows all Health Safety & Environmental and Occupational Safety and Health Administration (OSHA) policies and procedures. · Operates computer systems including National Donor Deferral Registry (NDDR) system and Cross Donation Check System (CDCS) within approved guidelines. · Understands and performs timely proper computer entry. · Documents comments on donor data including exceptions. · Answers the telephone in a courteous and friendly manner and provides information to caller(s) or transfers calls to appropriate personnel, as needed.

Managerial / Supervisory

N/A

General

Must be able to execute all terms and conditions set forth in the KEDPLASMA Employee Handbook, including,

but not limited to:

· Work in a safety-conscious manner which ensures that safe work practices are used in order not to

pose a risk to self or others in the workplace.

· Comply with company Global Code of Conduct and company’s policies and procedures and all the

applicable regulations.

· Maintain a dependable attendance record and adhere to standards of cleanliness, grooming, hygiene,

and dress code.

· Attend and participate in scheduled training, educational classes, and meeting(s) in a timely manner as

instructed by supervisor/manager.

· Cooperate with department personnel, as well as other center staff to ensure services can be

adequately maintained to meet the needs of the donors.

· Meet with supervisor/manager on a regular basis to assist in identifying and correcting problem areas

and/or improving services.

· Complete all assigned tasks in a timely manner as instructed by supervisor/manager.

· Adhere to work schedules in completing and performing assigned tasks.

· Promote KEDRION Values: Together as One; Care; Integrity; Sustainable Impact; and Courage.

· Create and maintain an atmosphere of warmth, personal interest, and positive emphasis, as well as a

calm environment.

· Interact in a tactful, diplomatic, and humanistic manner with donors, visitors, and co-workers to provide a safe, efficient, and caring environment which ensures the self-respect, personal dignity, physical safety of each donor and center guest. · Treat donors, visitors, and co-workers with courtesy, respect, and dignity. · Perform any miscellaneous duties or work assignments, as required.

· Center Management, Donors, employees, auditors, inspectors, vendors, corporate staff, and visitors.

Education, Qualifications & Experience

· High school diploma, or equivalent, required.

· Minimum of one-year experience in a customer service environment, such as a medical office, retail

store, blood, or plasma collection center preferred.

· Clinical Laboratory Personnel license required (in the State of Louisiana).

Physical Requirements

Work is primarily light in nature, with exerting up to 50lbs of force occasionally and/or a negligible amount of

force frequently to lift, carry, push, pull or otherwise move objects. Use of fingers to type and / or enter numbers

on keyboards, keypads, etc. along with grabbing object(s). Additionally includes, reaching, handling, talking,

hearing, bending, stooping, and walking. Involves sitting, standing, and walking most of the time.

Working Conditions

· Primarily inside with well-lighted and well-ventilated areas.

· Exposure to Blood Borne Pathogens.

· Periodic exposure to an environment with a temperature of -40°C for short periods of time.