New · posted Oct 23
Regeneron · Biotechnology
Sr QA Investigation Specialist
- Rensselaer, NY
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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.
What you need
What you'll do
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
- Independently reviews and approves:
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.
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.
Pay and benefits
$78,700 – $128,700 a year
Employer provided$78,700.00 - $128,700.00
Annual bonuses or incentive plans
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Rensselaer, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Rensselaer, NYWorking conditions
When & where
- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8am-4:30pm
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in New York17 roles publishing pay
Senior & Principal roles in the US313 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $78,700 | — | $128,700 |
| New York (middle half) | $81,500 | $104,000 | $118,500 |
| All US (middle half) | $102,500 | $119,000 | $137,500 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 8 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA2
- GMP and compliance1
- Lab testing and methods1
- Documentation and SOPs1
- Quality systems and risk1
- Collaboration and leadership1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Regeneron on Regulatory Jobs
- 81
- Open roles
- 69
- Distinct roles
- 9
- Locations
By discipline
- Quality57 70%
- Regulatory21 26%
- Compliance & Safety3 4%
By level
- Associate & Specialist40 49%
- Manager21 26%
- Senior & Principal12 15%
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Sr QA Investigation Specialist at Regeneron
Open until filled. $79K–$129K a year, employer provided.