Quality Compliance Specialist
Regeneron
East Greenbush, NY0–2 yrs1h agovia LinkedIn
About the Role
Regeneron is seeking a Quality Compliance Specialist to join the Quality Assurance team. This role focuses on internal change controls, ensuring quality and compliance with cGMP, internal, external, and international requirements related to change control activities.
Location
- Rensselaer, New York, United States
- Work model: Monday-Friday, 8am-4:30pm
Key Responsibilities
- Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory, and SOP requirements.
- Facilitate cross-functional meetings, offering guidance and consultation to change control owners.
- Build strong relationships with end users, serving as a resource on standard change control processes.
- Partner with quality assurance colleagues and system end users to identify, develop, and implement continuous improvements to the change control system, processes, and related procedures.
- Interpret compliance and regulatory requirements, translating them into departmental systems, procedures, and documentation.
- Support regulatory and customer audits as a subject matter expert on change control.
- Analyze and interpret process and systems information, technical procedures, reports, and regulations to support decision-making in a cGMP environment.
Requirements & Tech Stack
- Strong working knowledge of biotech/pharmaceutical quality systems, including cGMP, FDA regulations, and familiarity with ICH guidelines and global regulatory standards.
- Digital proficiency in MS Word, Excel, and PowerPoint.
- Experience with Veeva/QMS is a plus.
Qualifications
- B.S. in life sciences or related field; proven experience may substitute for the education requirement.
- Associate Quality Compliance Specialist: 0-2+ years of experience.
- Quality Compliance Specialist: 2+ years of experience.
- Level will be determined based on experience.