The QA Material Supplier Specialist leads the evaluation and implementation of changes to Regeneron’s raw materials, assuring that the production of drug products meets or exceeds defined quality standards.
The day to day of the role may include, but are not limited to, the following:
- Participates in and performs raw material activities according to approved procedures including 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 the resolution of deviations (NOEs and DNFs) and change controls related to raw materials.
- Captures, 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 settles acceptability of results in accordance with the approved specifications.
- Ensures accurate and timely qualification of raw materials.
- Manages and tracks projects to ensure landmarks are achieved while following established timelines.
This role may be for you if you are looking for future leadership opportunities and interested in leading our internal change notification process for new and existing suppliers.
To be considered for this role you must hold a BS/BA in a related field and
- Associate QA Material Supplier Specialist: 0-2 years of experience
- QA Material Supplier Specialist: 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 eligible 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 Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental 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.