Quality Assurance Investigation Specialist

Regeneron Pharmaceuticals is hiring a Quality Assurance Investigation Specialist for our East Greenbush, Rensselaer County location. This is a full-time position dedicated to investigating and making critical decisions about pharmaceutical products and materials to ensure they meet our rigorous quality and regulatory standards.

About the Role

As a Quality Assurance Investigation Specialist, you'll be responsible for conducting thorough investigations into product and raw material issues, then determining the appropriate course of action for disposition. You'll work to guarantee that every decision aligns with current Good Manufacturing Practice (cGMP) regulations, company Standard Operating Procedures (SOPs), and Regeneron's quality assurance policies and procedures.

What You'll Do

• Lead investigations into deviations, failures, or quality concerns affecting pharmaceutical products or raw materials
• Analyze evidence and data to determine root causes and recommend remediation actions
• Make disposition decisions on products or materials based on investigation findings and regulatory requirements
• Document all investigation activities, findings, and decisions in compliance with SOPs and regulatory standards
• Collaborate with cross-functional teams to implement corrective actions and prevent recurrence
• Maintain detailed records that satisfy FDA and other regulatory oversight
• Support ongoing quality assurance activities and continuous improvement initiatives

What We're Looking For

• Education in pharmaceutical science, chemistry, biology, or a related field
• Experience with quality assurance investigations, root cause analysis, or pharmaceutical operations
• Strong knowledge of cGMP regulations and their practical application
• Proficiency with SOPs and quality documentation systems
• Analytical mindset with excellent attention to detail
• Ability to communicate findings clearly in written reports
• Commitment to regulatory compliance and product quality

About Regeneron Pharmaceuticals

Regeneron Pharmaceuticals develops medicines to address serious human diseases through cutting-edge research and development. Our East Greenbush operations support our mission to deliver innovative treatments to patients worldwide.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.