QA Specialist, Drug Product
Listed on 2026-10-14
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Production QC/QA, QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Role
QA Specialist supporting drug product manufacturing at Regeneron’s Rensselaer facility, focusing on start‑up, validation, and ongoing quality assurance of formulation, filling, inspection, and packaging operations.
Responsibilitiesdevelop/review SOPs, perform on‑floor quality reviews, support audits/inspections, manage quarantine and line clearances, and contribute to continuous improvement initiatives.
RequirementsB.S. in life sciences or related field; 2+ years (Assoc QA) or 4+ years (QA Specialist) experience in pharmaceutical quality assurance; proficiency with GMP, GxP, and validation processes.
High Valuesupport of drug product manufacturing, GMP compliance, cleanroom gowning, and physical demands; location on‑site in Rensselaer, NY, with potential for physical tasks up to 10 hours per shift.
Work Setup1st shift, Monday–Friday, onsite; physical environment requires gowning and cleanroom procedures.
We are currently recruiting a QA Specialist, Drug Product for our team in City of Rensselaer, NY, United States.
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