Quality Control Data Reviewer
About The Position
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Control Data Reviewer to join our team, supporting our Rensselaer, NY manufacturing site in an on-site role. In this role, you will help ensure that every raw material entering our manufacturing process meets the regulatory and quality standards our medicines depend on, while collaborating with QC laboratory analysts, Quality Assurance, and Manufacturing teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Requirements
- Have experience with data from multiple chemistry testing procedures and instrumentation (e.g., wet chemistry, HPLC, UPLC, FT-IR spectroscopy, optical or specific rotation, GC, Karl Fischer, titrations)
- Have familiarity with compendial testing procedures (USP, Ph.Eur, JP, BP)
- Possess excellent attention to detail and critical thinking skills
- BS/BA in Life Sciences, or related field, and a minimum of 2+ years related experience; or an equivalent combination of education and experience (for QC Data Reviewer level)
- BS/BA in Life Sciences, or related field, and 4+ years of experience; or an equivalent combination of education and experience (for Sr. QC Data Reviewer I level)
Nice To Haves
- Have experience with lab-related computer systems such as Empower, Nautilus LIMS, LabWare LIMS, or LabX
Responsibilities
- Execute detailed data review of test results generated by QC to ensure compliance with regulatory requirements, internal procedures, and specifications, supporting routine release, laboratory investigations, material qualification, and/or method validations
- Review electronic lab records, lab equipment calibration records, and logbooks
- Perform laboratory investigations
- Maintain continuous laboratory compliance with cGMP requirements, including laboratory cleanliness, proper documentation, and monitoring reagent expiry
- Participate in audits and training activities
- Contribute to special projects, such as writing and revising laboratory procedures, executing test plans, or supporting method validations
Benefits
- 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
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
