Job Description

Cryogene is the industry’s most trusted biostorage facility specializing in the secure storage of biological specimens. Utilizing the latest freezer technology and computer inventory control software, Cryogene will cost effectively fulfill all of your sample storage requirements. They have proudly provided storage, receiving and distribution for local, regional, national and international research centers for over 15 years.

The Biorepository Technician I performs a broad range of laboratory activities related to and in the support of freezing, storing, inventorying, packaging, manufacturing, aliquoting and shipment of biological materials, therapeutics, and clinical agents. Duties include storage, tracking, and retrieval of material from automated BioArchives as well as manual refrigerators, freezers, and liquid nitrogen units. In addition, preparing both categories of frozen cord blood units (HEMACORD®, and IND CBUs) for shipment to Transplant Centers while monitoring the shipments and updating the inventory database. The Biorepository Technician I is also providing samples (segments) from the frozen cord blood units for confirmatory tests and quality assessment, following mandated standards of regulatory and licensing agencies. Additionally, liaising with team members providing support, scheduling work, completing documents associated with SOPs, and additional repository activities.

PRIMARY RESPONSIBILITIES ( include but are not limited to)

• Performs receipt and inventory management of biological materials (including therapeutic drug products), data entry, relocation, retrieval, packaging and logistics operations according to standard operating procedures.
• Direct correspondence with clients for scheduling, inventory and addressing concerns or issues.
• Processes incoming materials for storage and distribution.
• Visually inspects specimens for quality and data accuracy, performs accurate data entry into electronic tracking system.

• Preparation of frozen cord blood units, Plasma and DNA samples along with testing segments for shipment to transplant centers utilizing aseptic technique and universal precautions.
• Proficiency in the use of appropriate temperature dependent shipping vessels depending on client’s requirements.
• Works closely with supervisors to support customer inquiries, such as discrepancies in shipments and inventory maintenance.
• Updates the client’s computer database with results of shipments, cutting segments and reference samples. Update the records for refusals and discarded non-conforming units.
• Responsible for ongoing inventory of samples, including reviewing documentation, data entry and labeling as necessary.
• Proper use of any temperature monitoring equipment as per CryoGene procedures.
• Reports incidents (monitoring equipment failures, transport delays, discrepancies) to CryoGene management.
• Compliance with quality system practices.
• Ensures project work areas are kept clean and free of any possible safety hazards.
• Understands and uses the inventory management, temperature monitoring, and site infrastructure systems.
• Works around hazardous substances and follows all safety guidelines to minimize exposure.
• Assures compliance to cGMP requirements and company quality systems.
• Ensures all job-related paperwork is correct, error-free, and completed in real time as per SOPs.
• Performs any tasks that may be necessary to execute specific projects.

• Undertakes any other additional duties as requested by the Operations Manager and or Operations Supervisor.
• Any related duties as assigned.

Position may require periodic evening work, as necessary to ensure cryorepository operation quality and service standards.

COMPETENCIES & PERSONAL ATTRIBUTES
• Good communication skills with client and team members.
• Understanding of quality systems in day to day processes.
• Understanding of aseptic technique and universal precautions.
• Supports operational excellence (30/30).
• Focus on priorities (80/20).
• Teamwork, collaboration, and accountability (90/10).
• Safety awareness.

QUALIFICATIONS AND EDUCATION REQUIREMENTS
• 2+ years experience of laboratory biological sciences with Associate's degree or Bachelor’s Degree in medical technology.
• Health, Safety and Environmental experience / qualification is desirable.
• Proficient computer skills, specifically with Microsoft Office Suite.
• Must be able to lift/carry up to 20-80 lbs.
• Frequent physical activity, i.e., walking, lifting, standing, cleaning, counting, etc.
• Prepare various reports and logs, scan manufacturing and shipping records to create electronic documents for batch records.
• Position requires minimally Read Only training in all applicable Cryorepository Operations SOPs, OJT for all transportation/delivery related SOPs
• Prior experience with pick/pack, ship, receive deliveries and inventory control procedure, preferred.

DRUG TEST
This position is subject to pre-employment drug testing in accordance with our commitment to maintaining a safe, and drug-free workplace.