QA Specialist (Raw Material Specification)

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Job description

We are currently looking to fill a QA Specialist (Raw Material Specifications) position to support our Raw Materials team. This position performs activities in support of the onboarding of new materials, raw material specification (SPEC) management, and execution of change controls to ensure material quality, etc.

In this role, a typical day might include the following:

• Performs continuous improvement of the QA Raw Material program using a variety of methodologies (QRM, Lean, etc.)

• Collaborates across the business to ensure the quality of raw materials and supporting documentation, such as SPECs.

• Supports 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 raw material documentation to ensure compliance with effective processes approved specifications.

• May train and/or mentor junior employees, including providing insights and education on processes and procedures.

• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement.

This role may be a fit for you if you:

• Have understanding of biologics manufacturing operations

• Good organizational skills and attention to detail

• Are driven and self-motivated

• Are a strong communicator

To be considered for this role you must hold a Bachelors degree in a scientific discipline or related field and the following amount of years of experience for each level:

• QA Specialist 4+ years

• Sr. QA Specialist 6+ years

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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$65,100.00 - $124,300.00

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