Phlebotomist II

JOB SUMMARY

Responsible to perform venipuncture on donors for plasmapheresis and is primarily responsible for the safety and care of the donor during the plasmapheresis process under the direction of the Center Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.

ESSENTIAL JOB FUNCTIONS

Responsible for performing venipuncture on donors for plasmapheresis and is primarily responsible for the safety and care of the donor during the plasmapheresis process under the direction of the Center Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.

MAIN DUTIES AND RESPONSIBILITIES

Core

• Self-introduction to donors prior to phlebotomy and understands their health requirements.
• Performs donor identification, review of records and arm/vein selection for phlebotomy (with use of appropriate gauge needles including removal and disposal) according to SOPs.
• Performs Haemonetics Autopheresis setup and programming with understanding of alarm signals during operation, shut down, and in the event of power failure.
• Monitors the safety and care of the donor during the plasmapheresis process.
• Maintains alertness for donor reactions and assist with reactions and notifies appropriate Medical Staff, as needed.
• Performs phlebotomy procedures in accordance with SOPs, to include arm preparations, collection volumes, restarts, and cell loss procedures.
• Facilitates donor flow throughout the plasma collection center with a sense of urgency, minimizing wait time by working carefully and efficiently.
• Maintains equipment calibration, standardization, and cleaning schedules according to SOPs.
• Reports damaged/faulty equipment to management.
• Performs test sample collection and identification, including NAT testing protocols.
• Performs prompt and competent response to donor complaints, reactions, or deferrals.
• Ensures the donor floor is properly stocked with supplies and soft goods.
• Prepares plasma collection center for audits by maintaining a clean, efficient work environment times and ensure sufficient operating supplies.
• Understands and performs proper DMS computer entry and comments for donor data and exceptions and assist in other activities as required.
• Records any required documentation accurately and in compliance with company SOPs.
• Ensures the 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.
• Follows all Health Safety & Environmental and Occupational Safety and Health Administration (OSHA) policies and procedures.
• Maintains a clean, orderly, and efficient work environment and ensures sufficient operating supplies are available as needed.
• Follows all SOPs, regulatory policies, and procedures, including the employee handbook.
• Responsible for remaining current on SOPs changes.
• Provides a high level of customer service and strives to meet all production goals.
• Performs prompt and competent response to donor complaints, reactions, or deferrals.
• Prepares equipment by performing PQ/calibrations and verifying required maintenance has been performed as outlined in the SOPs.
• Explains plasma collection center policies & rules, educates new donors on the use of therapeutic products made from plasma, donation process, tests performed, proper nutrition, donor fee structure, bonuses, center promotions, and any other information pertinent to the donor.

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, required.
• Phlebotomy Certification required in California.
• Minimum of two-year Phlebotomy experience required.
• Medical office, healthcare, blood or plasma collection center experience or equivalent experience preferred.
• Phlebotomist certification preferred.

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.