QA Material Supplier Specialist

Company Name:
This position is an integral part of the program assuring that raw materials used in manufacturing can be consistently supplied and are of the appropriate quality to ensure the production of drug products meeting or exceeding expectations while maintaining compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
Essential Duties and Responsibilities may include, but are not limited to, the following:
Participate in and perform raw material activities according to approved procedures including but not limited to the qualification of raw materials, evaluation of TSE/BSE statements from Suppliers, evaluation of Supplier Change for raw materials to support investigations, etc.
Performs continuous improvement of the QA Raw Material program using a variety of methodologies (QRM, Lean, etc.);
Supports and/ or leads the resolution of deviations (NOEs and DNFs) and change controls related to raw materials.
Gather, evaluate and provide information/documentation to support regulatory filings, regulatory agency inspections and inquiries, as well as partner and internal audits.
Analyze the raw material testing results and determine the acceptability of results in accordance with the approved Specifications.
Represent QA and interact with various functional areas in meetings pertaining to raw material issues including but not limited to Material Review Board, Material Council Board, 2S, Supplier Change Notification, Supplier Relationship Meetings, etc.
Manage and track projects to ensure milestones are achieved while complying with established timelines.
Experience and Required Skills:
Education and Experience:
Requires BS/BA in related field and minimum 3+ years of related experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regenerons unwavering commitment to combining good science & good business.

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