Sr QA Investigation Specialist

Build the future with us:

At Regeneron, we apply science and innovation to create life-changing medicines for people living with serious diseases. We are looking for a Sr. QA Investigation Specialist to support our Batch Review Operations. In this role, you will be the first point of contact for receiving and processing complaint notifications from external sources. This position lets you contribute to a fast-growing, science-driven organization that makes a meaningful difference for 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
• 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 into a wide range of investigations into differing subject matters
• Trains employees in investigative processes and techniques
• Coordinates and/or leads cross-functional meetings with multiple departments

Education Requirements:

Associate Specialist: Requires BS/BA in Life Sciences, Engineering or related field or equivalent combination of education and experience.

Specialist: Requires BS/BA in Life Sciences, Engineering or related field and 2 years of relevant experience or equivalent combination of education and experience.

Senior Specialist: Requires BS/BA in Life Sciences, Engineering or related field and 5 years of relevant experience or equivalent combination of education and experience.

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.