cGMP QA Change Control Specialist

Regeneron Pharmaceuticals Inc.; New York (NY); On-site; USD 67,000 - 110,000; Full time

Benefits offered by this job

Health and wellness programs

Stock for employees

Fitness centers

Job summary

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

This role ensures quality and compliance with cGMPs, internal SOPs, and international requirements through precise change control activities. You will review, edit, and approve change control documentation; facilitate cross-functional meetings; and advise change owners on best practices.

Qualifications

• Bachelor's in a scientific or engineering discipline with relevant experience in quality, production, regulatory (chemistry, manufacturing and control) and/or laboratory roles.
• Experience implementing cGMP requirements and knowledge of FDA regulations.
• Strong written and verbal communication and ability to work across functions.

Responsibilities

• Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory and SOP requirements.
• Facilitate cross-functional meetings and provide guidance to change proposal owners.
• Develop relationships with end users and advise on best practices in Change Control.

Skills

Attention to detail

Scientific judgment

Interpersonal communication

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

MS Word

Excel

PowerPoint

QUMAS

Job description

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

This role ensures quality and compliance with cGMPs, internal SOPs, and international requirements through precise change control activities. You will review, edit, and approve change control documentation; facilitate cross-functional meetings; and advise change owners on best practices.