Regeneron · 1 day ago
QA Specialist (On the Floor)
Rensselaer, NY
Full-time
Onsite
Mid, Senior Level
$60K/yr - $127K/yr
4+ years expRegeneron is seeking a Quality Assurance Specialist to join their Bulk Drug Substance QA team. The role involves leading on-the-floor activities to ensure compliance with Quality Assurance policies and procedures, while supporting product dispositioning and mentoring team members.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.)
Review, edit, or approve Regeneron controlled documents
Review and approve investigations associated with product or processes
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Investigate and/or participate in microbiological sample investigations
Gown into cleanrooms and controlled environments
Qualification
Required
Bachelor's degree
2+ years of relevant experience for Associate QA Specialist
4+ years of relevant experience for QA Specialist
6+ years of relevant experience for Sr QA Specialist
Understanding of biologics manufacturing operations
Ability to stand for periods of time when performing tasks on the floor
Preferred
Excel in a quality driven organization
Organized and have an attention to detail
Can prioritize multiple assignments and changing priorities
Benefits
Health and wellness programs
Fitness centers
Equity awards
Annual bonuses
Paid time off for eligible employees at all levels
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-13
2026-01-09
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