Quality Compliance Specialist, Change Control

Regeneron Pharmaceuticals • Rensselaer, NY

11d • $62,355 - $128,700

About The Position

Regeneron is seeking a Quality Compliance Specialist, Change Control to support its Fill Finish facility. The role ensures quality and compliance with cGMPs and internal, external, and international requirements related to change control activities. The successful candidate reviews and approves change control documentation, advises change proposal owners and end users, interprets applicable requirements, and supports audits and continuous improvement. The level—Associate Specialist, Specialist, or Senior Specialist—will be determined based on qualifications relevant to the role.

Requirements

• Bachelor’s degree in a scientific or engineering discipline or a related field.
• Relevant experience in quality, production, engineering, regulatory (chemistry, manufacturing and control), and/or laboratory work, with demonstrated accomplishments effectively implementing cGMP requirements. Minimum experience varies by level: Associate Specialist, 0–2+ years; Specialist, 2+ years; Senior Specialist, 6+ years.

Nice To Haves

• Experience in a change control function is strongly preferred.

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 and consultation to change proposal owners.
• Develop relationships with end users and advise them on change control best practices.
• Partner with Quality Assurance team members and system end users to identify, develop, and implement continuous improvements to the Change Control System, process, and associated procedures.
• Interpret compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation.
• Support regulatory and customer audits.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level