QA Specialist

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

The QA Systems Specialist ensures operational activities, as well covering Intermediate Structure activities, are compliant with international, European & local regulations (GMP, GTP, GDP, HBM) and standards (ISO, ICH, EDQM), internal quality requirements and linked Competent Authority & customer requirements.

PRIMARY RESPONSIBILITIES (include but are not limited to)

1. Support the local manager in implementing, maintaining, and monitoring the local QMS:

• Ensure Global QMS is deployed at local entity
• Implement the Local QMS at local entities/departments by:
  • Compiling legal regulations, customer requirements, and internal quality standards
  • Drafting and/or reviewing local SOPs according to the Global QMS
  • Ensuring their approval
• Maintain and monitor Integricell local QMS to ensure continuous improvement by:
  • Managing regulatory intelligence (identifying and maintaining existing or emerging international laws, guidelines, standards, regulatory rules, and ensuring changes are communicated through Integricell quality standards and procedures)
  • Continuously monitoring Integricell Local QMS through defined key performance indicators, internal audits, management quality review processes, and customer feedback to ensure consistent quality of products and services meeting patient’s and customer’s expectations

2. Ensure Implementation of Integricell global training strategy:

• Ensure the Global training program is deployed at the local entity by:
  • Developing local training packages and delivering effective training
  • Maintaining and monitoring the training system through key performance indicators, performing internal audits, and preparing for management review to ensure continuous improvement

3. Perform QA oversight over local Product/Process life cycle:

• Monitor product, process, and quality performance
• Identify quality-related issues and trends by assessing and approving Annual Quality Reviews
• Follow up on deviations, CAPAs, change controls, etc.

4. Support the manager in local regulatory activities (including internal and customer projects):

• Provide regulatory advice and guidance to Integricell, Technical Transfer, Quality Control, Operations, and Local QA Operations teams
• Provide regulatory support and advice for in-house and/or customer projects
• Provide technical review of data or reports to be incorporated into regulatory submissions, ensuring scientific rigor, accuracy, and clarity

5. Review the operational documentation, including batch records:

• Review forms, batch records, etc., in collaboration with the operational teams

6. Release batches:

• Release incoming materials
• Release final products

COMPETENCIES & PERSONAL ATTRIBUTES

• Systematic and methodological, with strong control of own work
• Analytical mind: able to anticipate impacts, think critically, act logically, and set priorities
• Skilled in persuasion and influence with contacts
• Proactive, takes ownership, and works autonomously

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• Bachelor’s degree in a life science-related field (or minimum 5 years of relevant experience within a GMP environment)
• At least 3 years of experience in a pharmaceutical, biotech, or CDMO environment, in a QA or RA role
• Strong regulatory and quality knowledge throughout the product lifecycle, with a focus on effective management and strategy
• Attendance to training sessions on human body material

Compensation: Up to $85K, commensurate with experience

Cryoport Systems is an Equal Opportunity Employer. Employees are eligible for a comprehensive benefits package that includes health insurance, paid time off, paid holidays, a 401K with company match and stock equity (Nasdaq: CYRX).

To learn more about Cryoport Systems, please visit https://www.cryoport.com/