At Fisher BioServices, we specialize in the management of critical biological materials in support for the advancement of cell therapy, high value biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the bedside. Fisher BioServices is a brand of Thermo Fisher Scientific, the world leader in serving science, and member of the BioPharma Services Division. To learn more please visit www.fisherbioservices.com .
Position Summary: This position is entry level and is responsible for acquiring the skills to do the receipt, inventory, storage, withdrawal and shipment of biological specimens, samples, clinical agents, and materials from multiple commercial and government clients . These materials are stored at temperatures ranging from ambient (room temperature) to below freezing with potentially hazardous properties. This position uses database applications and standard precautionary procedures to work independently, be self-directed, communicate effectively, and use good judgment when making decisions . Internal or external client interaction occurs under the guidance of experienced professional or technical staff. This position may also participate in the assembly of kits and label printing.
Essential Duties and Responsibilities: Operations Technician 1duties:
- Prepares samples or clinical agents for pickups, courier deliveries, and shipments .
- Works closely with managers to support customer inquiries, discrepancies, inventory maintenance and database updates.
- Responsible for using an inventory management system for data entry, sample tracking, and management of samples .
- Maintains files for validation of data and preparation of queries, reviews accumulated data for accuracy and prepares reports of information and sample data.
- Performs internal specimen consolidation and reorganization projects under the guidance of a Lead Operations Technician .
- Participates in process improvement activities .
- Receives, handles and inventories specimens of human, animal, and/or plant origin at temperatures ranging from ambient to -196°C, and having potentially hazardous properties.
- Assures compliance to cGMP parts 210 and 211 and company quality systems.
- Follows standard operating procedures (SOPs), facility safety guidelines, and Food & Drug Administration (FDA) requirements which may include compliance with cGMP CFR parts 210 and 211 where applicable .
- May prepare sample collection kits in accordance with Standard Work Instructions.
- May make deliveries to clients as required.
- May be required to travel to other facilities to meet business needs.
- Other duties may be assigned to meet business needs.
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.
- Requires ability to communicate effectively verbally and in written form.
- Requires ability to prepare reports using Microsoft Excel.
- Requires knowledge of Windows and Microsoft Word and possibly Microsoft Access .
- High School Diploma
- Prefer work experience with data entry, shipping/receiving and sample management .
- Prefer knowledge of methods to handle, process, and store specimens using a computerized storage and retrieval system.
- Prefer knowledge of Universal Precautions, general laboratory and quality assurance/control.
- Valid driver's license and good driving record if required to transport material.
Certificates and/ or Licenses:
- IATA Dangerous Goods Training for Class 6.2 Shipping.
- Blood Borne Pathogens Training.
8AM to SPM core hours with additional hours as required. May be required to work non-traditional work week or work hours.
Work Conditions/Physical Requirements:
- Ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
- May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.
- Must use personal protective equipment and adhere to safety protocols .
- Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
- Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (- 1960C) for up to 6 hours per day.
- Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hours per day.
- Must be able to use a computer up to 6 hours per day.