QA Material Supplier Specialist

The QA Material Supplier Specialist is an integral part of the program assuring that raw materials used in manufacturing are of the appropriate quality to ensure the production of drug products meeting or exceeding expectations.

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Participates in and performs 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 and acts as the lead for the change notification process
• Ensures accurate and timely qualification of materials;
• Performs continuous improvement of the program using a variety of methodologies (QRM, Lean, etc.);
• Supports the resolution of deviations (NOEs and DNFs)and change controls related to raw materials.
• Gathers, evaluates and provides information/documentation to support regulatory inspections and inquiries, as well as partner and internal audits.
• Analyzes and reviews the raw material testing results and determines the acceptability of results in accordance with the approved specifications
• Manages and tracks projects to ensure milestones are achieved while complying with established timelines

Education and Experience:

• Associate Specialist: Requires BS/BA in a related field or equivalent combination of education and experience; 2 years of experience preferred.
• Specialist: Requires BS/BA in related field and minimum 3+ years of related experience.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveller community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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