Overview
The primary purpose of the Biotechnician level II position is to assist the Lab Director in setting up and validating the GMP facility and equipment, optimizing the collection, processing, testing and biobanking. Taking customer service calls and training other technicians.
Experience
- Having significantly worked in a CLINICAL laboratory extracting blood, cells or tissues. Performing routine cell and tissue culture FOR CLINICAL USE, processing, cell and molecular testing and cryopreservation. At least 2 years working in a Good Manufacturing Practice (GMP) environment.
- Significant experience understanding and assisting in the creation of Standard Operating Procedures.
- Significant customer service support.
- Must have a bachelor’s degree or equivalent in the field of health or biological sciences
- Must have training in blood, cell or tissue products biobanking for research and therapy.
- Formal training may include practical work experience in a facility, fellowship, or a certification program.
- Must have excellent organizational skills.
- Must pay excellent attention to detail.
- Must have excellent English writing skills.
- Phlebotomist is a plus.
- Excellent Spanish speaking and writing is a plus.
Key Responsibilities
- Operate under strict aseptic and cGMP standards
- Maintain a sterile and clean environment.
- Assist in creating Standard Operating Procedures.
- Perform procedures and maintain accurate documentation in compliance with current Good Laboratory Practice, current Good Manufacturing Practice and current Good Tissue Practice regulations and applicable accreditation agency standards, including but not limited to AABB, FDA, FACT-NetCord, CAP and CLIA.
- Participate in the daily functions of the Cord Blood and Tissue Biobank, including data and records management, inventory management, ordering and logging of supplies and reagents, cleaning, temperature monitoring, ancillary office and administrative functions.
- Responsible for the quality control and documentation of all equipment, reagents and supplies that are used for cord blood and tissue collection, processing, testing and releasing.
- Document deviations and events; notify technical and quality management personnel in timely manner and assist in the investigation of the cause and any required corrective actions
- Assist in Facility Management.
- Communication with potential donor mothers/families, hospital staff and team members
- Promote, educate and recruit expectant mothers through explanation of the cord blood and tissue biobanking program and participation in maternity hospitals
- Perform initial screen to identify suitable potential cord blood and tissue biobanking mothers
- Explain the public and private biobanking program.
- Obtain informed consent from all potential cord blood and tissue biobanking mothers for the collection, testing and use of the cord blood and tissue.
- Evaluate expectant mothers for suitability to donate or preserve infant's cord blood and tissue.
- Interview donor and private mothers to obtain answers to a standard questionnaire designed to elicit behavioral risk factors, medical and travel history information of the donor or private mother and infant's immediate family.
- Participate in the education of hospital staff
- Train obstetricians in the in-utero collection technique, including retraining as required, and monitoring of competency on an annual basis.
- Must have excellent verbal communication skills.
- Transport Biospecimens Safely Using Utmost Care.
- Make sure that cord blood and tissue are secure, transported on time and temperature controlled.
- Process and Biobank Biospecimens
- Work aseptically and strictly according to SOPs.
- Responsible for the collection of cord blood, cord tissue and maternal blood samples using aseptic techniques.
- Assist and/or prepare supplies for the obstetricians performing in-utero collections.
- Collect and/or facilitate drawing of maternal blood samples.
- Prepare the cord blood and tissue collections, maternal samples and paperwork for transportation to the Cord Blood and Tissue Bank on pre-arranged schedule.
- Utilize various computer systems and databases to enter data and complete donor or private mother and donor infant records.
- Review hospital charts.
- Develop and Perform Quality Controls.
- Validate and perform different testing protocols including PCR, bacterial culture and flow cytometry.
- Assist in Research and Development
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