What are the responsibilities and job description for the Laboratory Technologist position at KEDPLASMA LLC.?
Job Description
Job Description
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 :
Perform any miscellaneous duties or work assignments, as required.
PRIMARY CONTACTS
REQUIREMENTS
Education, Qualifications & Experience
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
Travel
N / A