Change Control QA Specialist - cGMP Compliance

Regeneron Pharmaceuticals, Inc; Town of East Greenbush (NY); On-site; USD 67,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Quality Assurance Compliance Specialist, Change Control to support our Fill Finish facility in Rensselaer, NY. The role focuses on reviewing and approving change control documents, guiding cross-functional teams, and ensuring compliance with cGMP and FDA regulations.

The candidate will partner with QA and end users to implement improvements and support audits, with a strong emphasis on regulatory interpretation and best practices in Change Control.

Qualifications

• Experience in change control function is preferred.
• Knowledge of biotech/pharma quality systems including cGMP and FDA regulations.
• MS Word, Excel and PowerPoint; familiarity with QUMAS.

Responsibilities

• Review, assess, edit, and approve change control documentation for compliance.
• Facilitate cross-functional meetings and guide change proposal owners.
• Advise on best practices in Change Control and system improvements.
• Collaborate to identify and implement continuous improvements to Change Control.
• Interpret regulatory requirements for departmental procedures.
• Support regulatory and customer audits.

Skills

Change Control

Quality Compliance

cGMP

FDA regulations

ICH guidelines

Education

Bachelor's degree in science or engineering

Tools

MS Word

Excel

PowerPoint

QUMAS

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Quality Assurance Compliance Specialist, Change Control to support our Fill Finish facility in Rensselaer, NY. The role focuses on reviewing and approving change control documents, guiding cross-functional teams, and ensuring compliance with cGMP and FDA regulations.

The candidate will partner with QA and end users to implement improvements and support audits, with a strong emphasis on regulatory interpretation and best practices in Change Control.