Quality Assurance Technician

Cryoport Systems • Morris Plains, NJ

5d

About The Position

Cryoport Systems is a comprehensive supply chain partner for the life sciences industry, delivering specialized solutions to meet the challenges of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health markets. Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting, ensuring the highest standards of quality and reliability for sensitive materials. With our expansive platform of management solutions and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ by supporting certainty and precision in the supply chain, whether advancing groundbreaking therapies, supporting families on their reproductive journeys, or enhancing animal health programs.

Requirements

• Quality Management System (QMS) compliance
• Adherence to quality policies, procedures, processes, programs, and practices
• Compliance with (GxP) processes, ISO 9001 standards, and other related regulatory standards
• Investigational analyses for root-cause evaluation/determination
• CAPA implementation and effectiveness review
• Review of Quality Systems documents (master batch records, investigation reports, SOPs)
• Development of standard work practices, instructions, procedures, job aids, and business processes
• Maintenance of Document Control records
• Maintenance and reporting of Key Performance Indicators (KPIs)
• Inventory management and record maintenance
• Support during internal audits, regulatory agency inspections, and third-party inspections
• Providing instruction and guidance on quality issues
• Conducting GMP Training
• On-the-job training for new Quality Operations employees

Responsibilities

• Responsible for Quality Management System (QMS) compliance. Establish and adhere to all quality policies, procedures, processes, programs, and practices to ensure continued conformance with appropriate standards and regulations.
• Ensure actions and systems are compliant with (GxP) processes (aligned with the business's current and future needs), ISO 9001 standards, and other related regulatory standards.
• Assist in the process of investigational analyses pertaining to root-cause evaluation/determination, CAPA implementation, and effectiveness review of said actions taken.
• Assists in review of documents related to Quality Systems such as master batch records, investigation reports, SOPs, and other documents as needed.
• Assist in developing standard work practices and instructions, procedures, job aids, and business processes.
• Assist in maintaining appropriate Document Control records for the department and site.
• Maintain and report Key Performance Indicators for the company to ensure monitoring of quality and regulatory compliance.
• Inventory management along with meticulous record maintenance regarding the services provided by Cryoport Systems, LLC.
• Supports site operations during an internal audit, regulatory agency, and third-party inspections.
• Provides instruction and guidance on quality issues and serves as a resource for the site.
• May conducts GMP Training for functional areas supported and provides on-the-job training to new Quality Operations employees, as requested.
• Any other duties, as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed