Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Quality Assurance (QA) Specialist/Reviewer to support our Fill Finish facility. In this role, you will perform all compliance related tasks necessary to review and approve investigations and provide quality oversight to the implementation of robust corrective actions for supporting manufacturing operations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
Location: Rensselaer, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Discover your role:
Independently reviews and approves:
Investigations into non-conformances and proposed actions to prevent reoccurrences in support of manufacturing operations
Laboratory investigations into out of specification (OOS) and out of trend ( OOT) results
Supplier corrective action requests and proposed vendor actions
Coaches investigation team to enable preparation of investigation reports that include recommendations on investigation findings for medium/high severity non-conformances
Analyzes and evaluates information captured through investigations, summarizes information and trends in investigation reports
Presents quality considerations and recommendations at group meetings with multiple levels of management
Reviews primary data sources to assure the accuracy of investigative conclusions in accordance with cGMP standards in support of investigations
Provides quality reviews and oversight on a wide range of investigations of differing subject matter
Monitors production processes and quality systems data to acquire vital data in support of investigations and track efficiency of changes
Participates in and/or leads cross-functional study teams to get results
Captures, trends and analyzes process related data to drive consistency and timeliness
Trains employees on investigative processes and techniques
Coordinates and/or leads cross-functional meetings with multiple departments
This role requires:
BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
Principal QA Specialist: 8+ years of relevant experience
Staff QA Specialist: 10+ years of relevant experience
Level will be determined based on experience
Experience with sterile drug product manufacturing, fill finish and/or quality control testing
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$92,200.00 - $176,000.00
We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.
Curious what that looks like step by step? Check out How We Hire.
Here, you’ll collaborate with teams across regions to help move our mission forward.
We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.
From application to your first day — here's how it works.
Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.
See something you like? Submit your application for the role that fits your background and goals.
We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.
After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.
Nachdem du unser Angebot angenommen hast, unterstützen wir dich bei der Vorbereitung auf deinen ersten Arbeitstag. Ob wichtige Unterlagen, Informationen zu deinem Arbeitsplatz oder, falls erforderlich, Unterstützung bei einem Umzug – wir sorgen dafür, dass du bestens vorbereitet in deine neue Rolle starten kannst.
