JOB SUMMARY

Responsible for performing laboratory procedures related to specialty plasma under the direction of the Laboratory Manager. Operates within the scope of Good Laboratory Manufacturing Practices, cGMP, CLIA and OSHA regulations.

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.

MAIN DUTIES AND RESPONSIBILITIES

Core

• Records temperatures of laboratory rooms, equipment (refrigerators, freezers, water baths, etc.) as scheduled per SOP.

• Ensures temperatures are within established parameters and if unacceptable, notifies supervisor and takes appropriate corrective action(s).

• Calibrates and maintains laboratory instruments, analyzers, and equipment.

• Performs and documents Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) on laboratory instruments and equipment.

• Completes preventative maintenance which does not require an outside service technician.

• Processes incoming samples and shipments, as needed.

• Completes data entry of antibody consultation reports including specialty plasma inventory and titer results.

• Performs laboratory tests and procedures regularly including Quality Control and Quality Assurance tests.

• Prepares samples and paperwork for shipment adhering to proper temperature storage guidelines.

• Signs off Operations Screener duties when appropriate.

• Trains new staff and performs Annual Competencies.

• Performs Sample Management and sorting, including data entry of test results on specialty plasma.

• Performs Laboratory Assays.

• Deglycerolizes RBC Ped Packs for immunization, if applicable.

• Freezes WB iRBC units, if applicable.

• Performs instrument / equipment validation, calibration, maintenance, and Quality Control (QC).

• Provides monthly stats and charts to monitor shifts and trends.

• Prepares and pipettes individual unit samples into Pool/Shipment samples.

• Prepares in-house reagents, standards, and controls for select assays.

• Prepares shipment of samples, including vials, to appropriate labs, centers and customers as needed.

• Participates in Proficiency Testing as per applicable State regulations.

• Performs manual data entry of test results into the DMS.

• Maintains and reviews records.

• Reviews inventory needs as required.

• Prepares Medical Waste for Pickup & Destruction, including proper disposal of hazardous materials.

• Provides support to create and revise Laboratory SOPs.

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.

PRIMARY CONTACTS

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

REQUIREMENTS

Education, Qualifications & Experience

• Baccalaureate degree in Medical Technology required.

• Applicable State License in Medical Technology required.

• Minimum three years of laboratory experience or equivalent combination of education and work experience preferred.

• Completion of CEUs to maintain State License required.

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.

• Exposure to an environment with a temperature of -40°C for long periods of time (i.e., several hours).

Travel

N/A

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.