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QA Specialist

Job Description

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The QA Specialist performs activities in support of onboarding new molecules and ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. This position involves Validation and Commercial Packaging with Contract Manufacturing Operations (CMOs).

In this role, a typical day may include:

  • Supporting activities involving the onboarding of new molecules (e.g. engineering studies, packaging line trials, OQ, PQ, and Validation runs)

  • Perform routine activities associated with disposition of product lots (e.g. batch documentation and ancillary documentation review and approval, etc.)

  • Represent Quality Assurance and Regeneron in interactions with CMOs, cross functional teams within Regeneron, and other external parties

  • Provide consultation or advice in alignment with QA procedures and policies

  • Activities are performed in the office with the potential for travel (up to 25% travel annually is expected)

  • Review, edit, or approve Regeneron controlled documents

  • Represent Quality Assurance in support of Deviations, Change Controls, Corrective and Preventative Actions, etc., including active participation in investigation, evaluation, and problem resolution

  • 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:

  • The ability to lead a variety of projects

  • An understanding of biologics manufacturing and packaging operations

  • Good organizational skills and attention to detail

  • Good written, verbal, and interpersonal communication skills and the ability to effectively interact cross-functionally

  • The ability to handle multiple assignments and changing priorities

  • The ability to learn and use computerized systems for daily performance of tasks

  • The ability to prioritize, lead multiple tasks, and meet deadlines

  • The ability to work a multifaceted schedule including off-shift and weekends

  • The availability to travel up to 25% annually

To be considered for this role you must hold a BS/BA in a scientific discipline and the following 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 based on qualifications relevant to the role.

#REGNQA

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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$65,100.00 - $124,300.00