Cellular Therapy Processing Technician

• 24 Days PTO! - Use it, Cash it, Roll it
• Potential Company Bonuses
• Tuition Reimbursement 
• 401k Retirement Plan
• Health Insurance (Medical, Vision, and Dental)
• Healthcare and Dependent Care FSA
• Short and Long-Term Disability
• Employee Assistance Program (EAP)
• Basic Life Insurance

Schedule:

• 1st shift: Monday to Friday (8:30am - 5:00pm) with occasional after hours 

Position Overview

• Possesses knowledge of clinical laboratory procedures and a working knowledge in the relevant specialty area of cellular therapies.

• Requires the application of this knowledge through the performance of processing, cryo-preservation, storage, infusion, and patient tracking of cellular products.

 Proficient in:

• Laboratory procedures, with special emphasis on analytical practices, principles and instrumentation used
• Monitoring of quality indicators at each critical step in cellular product handling
• Communication with clinical sites, hospitals and physicians
• Working with others in order to fulfill the mission of The Blood Connection

Essential Functions
 
Product Transport:

• Prepares transport coolers for fresh products
• Prepares transport containers for cryopreserved products
• Effectively removes units from cryopreserved inventory/ packs for transport and correctly completes associated documents

Product Handling:

• Uses aseptic technique
• Performs evaluation of cellular products upon receipt
• Processes cellular products for cryopreservation
• Processes cellular products for fresh infusion
• Performs controlled rate freezing on products for cryopreservation
• Prepares labels following regulatory guidelines for all products types and ensures accuracy
• Assigns and places cryopreserved products into LN2 storage units and properly adjusts inventory
• Properly handles inventory placement of quarantine caliber products

Testing Performance:

• Performs automated cell counts on donor samples
• Performs analysis for CD34 antigen
• Performs cellular viability percentage determinations
• Inoculates appropriate media for sterility testing

Send-out Testing:

• Prepares requisitions and specimens for shipping
• Tracks receipt and results to completion

Supplies and Reagent Management:

• Monitors reagent and supplies inventory for adequacy
• Documents receipt and inspection upon arrival
• Ensures critical good approval by QS when necessary
• Reports non-conformances to CTP laboratory director

Product Inventory Management:

• Participates in cellular therapy product storage surveillance to monitor critical conditions
• Monitors liquid nitrogen supply and ensures adequacy to meet needs
• Monitors and manages product inventory
• Performs chart audits and identifies products eligible for disposal
• Prepares disposal forms and routes to CTP director or appropriate physicians for approval and signature
• Tracks progress of disposal process and performs product disposal when authorized
• Adjusts product inventory to generate inventory reports and billing information

Infusion Preparation:

• Prepares fresh and cryopreserved cellular products for infusion following the prescribed order of the attending physician
• Prepares infusion summary forms and infusion documents required for transport, receipt, infusion and follow-up

Document and Record Management:

• Assembles charts for new patients
• Enters and reviews all data entered into StemLab
• Reviews faxes of laboratory results and orders, records results and files appropriately
• Identifies documents and reports requiring the Medical Director’s review and signature
• Performs review of worksheets or StemLab records completed by other personnel in a timely manner as established
• Performs chart audits to ensure all required documents are present
• Completes summary reports for each harvest and distributes to clinical and collection facilities prior to high dose chemotherapy or infusion for immunotherapy
• Follows record retention guidelines

Equipment Care:

• Performs QC for equipment and instrumentation according to established guidelines
• Performs equipment preventive maintenance as scheduled
• Calibrates equipment at required intervals
• Performs validation tasks as required

Quality Assurance:

• Submits occurrences, equipment malfunctions, deviations, etc. to appropriate parties
• Participates in external proficiency testing for appropriate analyses on a rotating schedule
• Monitors and benchmarks comparisons of specified operating conditions
• Assures records are generated according to instructions in related procedures and that applicable regulatory requirements and accreditation standards are met

Communications:

• Communicates product evaluations and processing results to the clinical and collection facilities as completed
• Reports non-conforming events and adverse reactions to appropriate parties as identified and documents notification; performs follow-up and resolution reports as directed

Training:

• Assists in training cellular transport personnel and technical personnel as needed

Miscellaneous:

• Actively pursues opportunities for continuing education in the field of cellular therapy
• Other duties as assigned or required

Minimum Qualifications

• Bachelor’s degree in a Science related field or MLT
• Some laboratory experience preferred
• Demonstrates an understanding of the design and operating principles of a transplant program
• Excellent customer services skills
• Ability to read, understand, and follow written and verbal instructions
• Ability to follow SOP in a heavily FDA regulated environment
• Ability to communicate effectively, tactfully, and courteously to patrons, donors, sponsors and co-workers
• Ability to work with all levels and in a diverse work environment 
• Ability to establish and maintain effective working relationships with staff, management, and peers

Physical Demands
 
The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   

• Lifting, carrying, pulling and/or pushing up to 50 pounds
• Repetitive sitting to standing movement throughout a shift
• Bending and twisting