Principal QA Material Supplier Specialist (Change Notification)

Principal QA Material Supplier Specialist

Our Material & Supplier Quality Assurance team is hiring a Principal QA Material Supplier Specialist to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality, compliance, and supply. This role provides global coordination for supplier change notifications.

When & where:

• Rensselaer, NY
• Monday-Friday

Discover your role:

• Reviews and coordinates Supplier Change Notifications across global suppliers, including intake, triage, risk assessment, cross functional impact evaluation, communication, and closure.
• Supports the resolution of internal and external deviations, and Supplier Corrective Action Requests (SCARs) related to materials and supplier changes.
• Maintain and update controlled documents related to supplier change notification.
• May execute Corrective/Preventative Actions (CAPAs) arising from supplier changes, audits, or process gaps.
• Gathers, evaluates and provides information/documentation to support regulatory inspections and inquiries, as well as partner and internal audits.
• Performs continuous improvement of the Material & Supplier Quality program with a focus on SCN workflow efficiency, cycle time reduction, and right first time.
• Manages and tracks projects to ensure milestones are achieved while complying with established timelines.

This role requires:

• A Bachelor's degree in scientific subject area or related field and the following years of experience for each level:
• Sr. Specialist: 5+ years
• Principal Specialist: 8+ years
• Experience partnering with suppliers of GMP materials/components preferred.
• Previous quality experience in a GMP environment.

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.