Regeneron · 18 hours ago
QA Specialist (Visual Inspection & Packaging)
East Greenbush, NY
Full-time
Onsite
Mid, Senior Level
$62K/yr - $129K/yr
4+ years expRegeneron is seeking a Quality Assurance Specialist to support Visual Inspection, Assembly, and Packaging operations at their Fill/Finish facility. The role involves providing floor support during production and ensuring compliance with FDA and international regulatory requirements.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Oversee programs to support visual inspection, assembly, and packaging operations at the Drug Product facility
Ensure that facilities, equipment, materials, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other Regeneron controls
Develop or update, review, and approve SOPs, specifications, and other documents to support drug product operations
Execute daily operations, including but limited to:
Providing Quality oversight and guidance during on-the-floor manufacturing
Executing daily on-the-floor duties to ensure facilities, equipment, materials, and documentation comply with SOPs and safety standards
Performing quarantine and segregation of material
Performing line clearances activities
Perform Acceptable Quality Level (AQL)
Review and approve procedures, documents and records, including but not limited to Batch Production Records, and Protocols
Ensure that EBR/Batch Records are complete, accurate, and documented according to written procedure
Quality support in electronic batch record designed, review, and approval
Author/Review/Approve Quality documents, such as Standard Operating Procedures (SOP’s), Risk Assessment (RA), training materials, training documents, protocols and reports
Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections
Identification and implementation of continuous improvement opportunities within our processes and systems and contribute to the continuous improvement culture
Maintain project timelines associated with initiatives to support the evolving business
Qualification
Required
Bachelor's degree in Life Sciences or related field
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
Must pass a visual acuity exam, including color assessment
Must successfully complete the visual inspection training and qualification program
Capable of building strong interpersonal skills with ability to collaborate on cross functional teams
Demonstrate ability in problem solving
Strong organizational skills, including to follow assignments through to completion
Ability to work in a fast-paced and dynamic environment
Apply critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
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
2026-01-09
2026-01-08
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