Operations Technician-USA

Cryoport Systems - Morris Plains, NJ

Full-time - Entry Level

Morris Plains, NJ

Professional, Scientific, and Technical Services

About the position

The Operations Technician Bioservices role is responsible for ensuring all operational activities are executed accurately and timely, following specific procedures and processes as defined in Work Instructions. This role involves the receipt, inventory, storage, withdrawal, packaging, labeling, and shipment of biological materials, therapeutic products, clinical agents, and materials from multiple commercial and government clients. The Operations Technician Bioservices may also participate in the assembly of various types of kits and label printing, involving materials stored at temperatures ranging from ambient (room temperature) to below freezing (including cryogenic) with potentially hazardous properties.

Responsibilities

• Receipt and inventory management of biological materials (including therapeutic drug products), data entry, relocation, retrieval, packaging, and logistics operations according to standard operating procedures
• Packaging and labeling of pharmaceutical product at all temperatures (including low and ultra-low temperatures) according to standard operating procedures
• Assembly of a range of kit types according to strictly defined client specifications
• Liaising with Program Managers to provide support regarding the scheduling of work, assisting in writing and updating SOPs and other project-related activities
• Assist in deviation investigations and change control documentation
• Scheduling of project work and accounting for deadlines, available resources, and business need
• Disseminating information from and providing feedback to Project Managers
• Coordinate stock management and receipt of kit production, packaging, and labeling materials
• Manage stock levels of kit materials, packaging, and labeling components
• Assist with Quality Control tasks such as verification, validation and calibration procedures as required
• Ensure 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
• Primary responder to all equipment alarms and active member of the site On-Call team, responding to all alarms including out-of-hours (24/7 on a rotating cycle with other team members)
• Being available for infrequent overtime work as necessary, willingness to attend site, out-of-hours in the case of an emergency or extraordinary work requirement
• Document alarms in response to the temperature monitoring systems
• Work around hazardous substances and follow safety guidelines to minimize exposure
• Assure compliance to cGMP requirements and company quality systems
• Maintain cGMP training records and participate in staff quality training
• Ensure all job-related paperwork is correct, error-free, and completed in real-time per instructions
• Ensure strict client confidentiality at all times
• Participate in, and contribute to, operational excellence and process improvement projects that cost-effectively deliver business objectives
• Assist in the supervision of temporary contract staff as required
• Participate in client audits and facility presentations as needed
• Effectively communicate to ensure all project related information is conveyed in a timely and comprehensive manner
• Perform project/task-specific training as required

Requirements

• Degree level, or equivalent experience, in a relevant discipline is preferred
• Minimum 1-2 years' experience working in a GMP/GxP environment
• Hands-on experience working with biological and pharmaceutical materials and drug products
• Proficient computer skills; specifically Microsoft Office Suite
• Experience working in a contract development or manufacturing environment is a plus

Nice-to-haves

• Previous experience working with materials at ultra-low & cryogenic temperatures is desirable
• Health, Safety and Environmental (HSE) experience/qualification is desirable
• Hands-on experience working in clinical packaging and labeling is desirable

Benefits

• Health insurance
• 401K with company match
• Stock equity