Senior Material QA Specialist - Supplier Changes (GMP)

Regeneron Pharmaceuticals, Inc.; New York (NY); Presencial; USD 67.000 - 129.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. in New York seeks a Senior Quality Assurance Specialist, Material Supplier to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality and compliance.

The role provides global coordination for supplier change notifications, supports CAPAs, maintains controlled documents, and drives improvements in the Material & Supplier Quality program. On-site in Rensselaer, NY.

Formación

• Bachelor’s degree in scientific subject area or related field required.
• Experience coordinating supplier change notifications and deviations.
• GMP environment experience preferred and regulatory inspections support helpful.

Responsabilidades

• Reviews and coordinates Supplier Change Notifications across global suppliers, including intake, triage, risk assessment, and closure.
• Supports resolution of internal and external deviations.
• Maintain and update controlled documents related to supplier change notification.
• Supports execution of CAPAs arising from supplier changes, audits, or process gaps.
• Gathers and provides information to support regulatory inspections and audits.
• Improves Material & Supplier Quality program to reduce cycle times and improve right-first-time.
• Manages and tracks projects to meet milestones within timelines.
• Experience partnering with GMP material/component suppliers.

Conocimientos

GMP experience

Supplier Change Notifications

CAPA execution

Educación

Bachelor’s degree in scientific subject area or related field

Descripción del empleo

Regeneron Pharmaceuticals, Inc. in New York seeks a Senior Quality Assurance Specialist, Material Supplier to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality and compliance.

The role provides global coordination for supplier change notifications, supports CAPAs, maintains controlled documents, and drives improvements in the Material & Supplier Quality program. On-site in Rensselaer, NY.