Principal Quality Assurance Reviewer

About this role

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

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

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