JOB SUMMARY

Responsible for the accurate and timely processing, sampling, and storage of plasma collected from donors under the direction of the Center Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.

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​ESSENTIAL JOB FUNCTIONS

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.

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​MAIN DUTIES AND RESPONSIBILITIES

Core

• Maintains safety and integrity of product and samples during processing, storage, and shipment release in accordance with Company SOPs.
• Performs plasma and sample processing according to cGMPs, customer specifications, State and Federal regulations and company policies.
• Performs sample centrifugation, label control, completion, and inspection.
• Classifies and documents the product according to donor programs.
• Responsible for aseptic sampling and heat sealing of plasma units and timely placement of units/samples into freezer per SOPs to ensure product quality.
• Ensures only one plasma unit and samples are properly labeled at a time and performed within the areas of unidirectional flow designated for each task according to SOPs.
• Alerts management of processing flow issues.
• Prepares equipment by performing PQ/calibrations and verifying required maintenance has been performed as outlined in SOPs.
• Monitors freezer and refrigerator temperatures and immediately inform management if equipment is not functioning properly.
• Manages product packing, and inventory within freezers for maximum efficiency.
• Controls disposition of unsuitable product with concurrent documentation.
• Prepares product shipment and verification.
• Receives, inventories, and maintains storage area for incoming supplies.
• Provides high level of customer service and strives to meet all production goals.
• Ensures all donor questions are answered timely, accurately, and professionally.
• Maintains a clean, orderly, and efficient work environment and ensure sufficient operating supplies are available as needed.
• Follows all SOPs and regulatory policies and procedures, including the employee handbook.
• Responsible for remaining current on SOPs changes.
• Follows all Health Safety & Environmental and Occupational Safety and Health Administration (OSHA) policies and procedures.
• Maintains data integrity and confidentiality of all personnel, donor, and plasma collection center information.
• Answers the telephone in a courteous manner and provides information or transfers calls to appropriate personnel, as required.
• Queries NexLynk daily to identify released units and stage for shipment.

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.

PRIMARY CONTACTS

• Center management, donors, employees, auditors, inspectors, vendors, corporate staff, and visitors.

REQUIREMENTS

Education, Qualifications & Experience

· High school diploma or equivalent.

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.