Change Control QA Specialist

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 its Fill Finish facility in Rensselaer, NY.

The role focuses on ensuring quality, cGMP compliance, and regulatory alignment for change control activities, with cross-functional collaboration and audit support. The successful candidate will review/change control documentation, guide owners, and help implement continuous improvements within the Change Control system, while leveraging MS

Qualifications

• Bachelor's degree in science or engineering with relevant QA exposure.
• Knowledge of cGMP, FDA regulations, ICH guidelines and global regulatory.
• Strong attention to detail, scientific judgment and analytical thinking.
• Ability to work independently and across cross-functional teams.

Responsibilities

• Reviewing, assessing, editing, and approving change control documentation to ensure compliance with quality, regulatory and SOP requirements.
• Facilitating cross functional meetings and providing guidance to change proposal owners.
• Developing relationships with end users and advising on Change Control best practices.
• Partnering with QA and end users to identify, develop, and implement improvements to the Change Control System and processes.
• Interpreting regulatory requirements for incorporation into systems and documentation.
• Supporting regulatory and customer audits.

Skills

Quality Assurance

Change Control

Regulatory compliance

cGMP

Education

Bachelor's degree in science/engineering

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Quality Assurance Compliance Specialist, Change Control to support its Fill Finish facility in Rensselaer, NY.

The role focuses on ensuring quality, cGMP compliance, and regulatory alignment for change control activities, with cross-functional collaboration and audit support. The successful candidate will review/change control documentation, guide owners, and help implement continuous improvements within the Change Control system, while leveraging MS