Quality Assurance Specialist - Bioservices

Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

Position Summary:

This position is responsible for the operations and day-to-day execution of duties associated with Quality Assurance in the BioServices sector of Cryoport Systems, LLC.

Activities include authoring procedures, execution of validation activities, (light) servicing of equipment, interactions with clients, product release, and quality oversite facility. The Quality Assurance Specialist will assist with the design, development of the operational platform of the BioServices sector as well as operate within this organization. Processes are to be constructed in such a way as to demonstrate adherence to ISO, GMP, and EMA standards and industry expectations. The Quality Assurance Specialist will be required to interact directly (est. < 20%) with sponsors and clients, placing work within the BioServices business unit.
Reporting directly to the Sr. QA Manager, the Quality Assurance Specialist will perform on-site duties within the BioServices area(s), with a focus on operational quality systems for handling biopharmaceutical/gene/cell/tissue materials, as well as processing these materials for return to sponsors/clients, or to alternative sites (such as a clinic). Also, other areas of concentration include Document Control, Equipment Calibration, Supplier Controls, Risk Management, CAPA Program, Training, and assistance in Monitoring Environmental controls for the BioServices areas.
Responsibilities include but are not limited to:

• Maintain appropriate Document Control records for the department and site.
• Authors review and approve documents related to Quality Systems such as master batch records, investigation reports, SOPs, and other documents as needed.
• Maintain and report Key Performance Indicators for the company to ensure monitoring of quality and regulatory compliance.
• Develop standard work practices and instructions, procedures, job aids, and business processes.
• Authors risk assessment as required.
• Inventory management along with meticulous record maintenance regarding the services provided by Cryoport Systems, LLC.
• 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.
• Any other duties, as assigned.
• 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 participate in Vendor/ Contractors Qualification activities as assigned.
• May conducts GMP Training for functional areas supported and provides on-the-job training to new Quality Operations employees, as requested.
• Assist in the process of investigational analyses pertaining to root-cause evaluation/determination, CAPA implementation, and effectiveness review of said actions taken

Competencies & Personal Attributes:

• Demonstrate the ability to communicate and influence decision-makers effectively.
• Willingness to continually embrace personal and professional development.
• Ability to travel as required.
• Passion for working in a values-based company in alignment with a learning organization.
• Must have strong self-motivation, work independently and within a team environment with strong follow-up, organization and prioritization skills, and excellent attention to detail.
• Knowledge of processes pertaining to the management (storage, inventory, secondary packaging, labeling, distribution) of (biological/gene/cell) drugs for clinical trials and commercial.
• Problem Solving. A clear understanding of the compliance requirements is preferred. Have the ability to collect objective evidence for investigations to solve problems, typically in situations where general standardization should exist but may not be operating effectively.
• Team Player. Ability to be involved in teams and meetings at every level of the organization.
• Demonstrates a passion and a responsibility for the Company’s clients.
• Ability to train and grow the competencies and capabilities of the quality assurance organization.
• Have strong Knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions.
• Ability to understand and comply with established company policies and procedures.
• Must possess excellent verbal and written communication skills;
• Organization and prioritization skills with excellent attention to detail and time management.
• Must have experience or familiarity in writing procedures, work instructions, and associated documents.
• Exhibit a passion for the Company’s Vision, Mission, Global Imperatives, and Corporate Direction.
• Passion and alignment with our mission, vision, values, and operating principles.

Qualifications and Education Requirements:

• EU 2003/94/EC / EU 2001/83/EC and EudraLex Volume 4
• WHO Annex 5 and Annex 9
• Bachelor’s Degree in life sciences, engineering, or other technical discipline.
• Experience with Temperature Controlled Products and Systems, with respective Monitoring Systems
• 21CFR Part 600 Biological Products o ICH Standards: Q10, Q7
• EMA Good Distribution Practice of Medicinal Products for Human Use
• 21CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products
• A solid understanding and work experience with Pharma based regulatory standards:
• A solid understanding and experience in Good Distribution Practices:
• Experience with Biopharma, Life Science, Distribution of Drug Products, or Medical Devices.
• Demonstrated experience working with suppliers and, subsequently, supplier controls. Preferred Skills
• Excellent technical writing skills.
• O21CFR Part 210 Current Good Manufacturing, Processing, Packing, or Holding of Drugs o 21CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
• USP Good Storage and Distribution Practices for Drug Products
• Experience with EDMS, Inventory Control, and monitoring systems, or similar
• 2-5 years prior experience in Quality Assurance and/or Regulatory Affairs.
• Ideally hold membership of a professional Quality related organization (eg ASQ / SQA / RQA)

$80-$100K