QA Specialist (External Bulk Production)

We are currently looking to fill a Quality Assurance Specialist (External Bulk Production) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

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

• Reviewing and approving batch records from Contract Manufacturing Organizations (CMO) manufacturing bulk drug substance including adeno-associated viruses (AAV), virus-like particles (VLPs), small interfering RNAs (si-RNA)

• Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution

• Providing consultation or advice in alignment with QA policies

• Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.), activities may be on the floor or at a desk

• Reviewing, editing, or approving Regeneron controlled documents

• Reviewing and approving of investigations associated with raw materials, product, laboratory, facilities, and materials

• Performing status labeling of raw materials and product

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

This role may be for you if you:

• Excel in a quality driven organization

• Have an understanding of AAV, VLP, si-RINA or biologics manufacturing operations

• Are organized and have an attention to detail

• Can prioritize multiple assignments and changing priorities

• Are able to learn and utilize computerized systems for daily performance of tasks

To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience for each level:

• QA Associate – 0-2+ years

• Associate QA Specialist – 2+ years

• QA Specialist – 4+ years

• Sr QA Specialist – 6+ years

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

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 Traveler 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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