QA Specialist (On the floor)

Role Summary

QA Specialist (On the floor) performs on-floor quality assurance activities to disposition product and raw materials while ensuring compliance with QA policies, cGMPs, SOPs, and Regeneron requirements. The role provides ongoing QA guidance on the manufacturing floor and supports investigations, deviations, CAPAs, and continuous improvements.

Responsibilities

• Work schedule: Sunday–Wednesday, 1st shift, 6:00am–4:30pm.
• Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, and related investigations, including active participation in investigation, evaluation, and problem resolution.
• Represent 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 the QA organization.
• Provide 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).
• Review, edit, or approve Regeneron controlled documents.
• Review and approve investigations associated with product or processes.
• Continually evaluate Regeneron processes and procedures with an eye toward continuous improvement.

Qualifications

• Required: Bachelor's degree.
• Required: 2+ years for Associate QA Specialist; 4+ years for QA Specialist; 6+ years for Sr QA Specialist. May substitute proven experience for education; level determined by qualifications.

Skills

• Strong QA knowledge, familiarity with cGMPs, SOPs, and quality systems.
• On-floor presence with the ability to communicate with internal teams and external partners.
• Training, mentoring, and process-improvement capabilities.
• Document control, deviation/investigation handling, and CAPA execution.
• Attention to detail and ability to manage multiple priorities.

Additional Requirements

• Gowning and cleanroom environment: full cleanroom attire and PPE as required, including removal of jewelry, makeup, and nail adornments when wearing cleanroom attire.
• Ability to stand for extended periods on the manufacturing floor.