QA Specialist (On the Floor)

Role Summary

QA Specialist (On the Floor) at Regeneron. This role performs and leads on-the-floor activities to support dispositioning of product and/or raw materials, ensuring compliance with QA policies and procedures, cGMPs, SOPs, and Regeneron standards.

Responsibilities

• Represent Quality Assurance in support of complex deviations, change controls, CAPAs, 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 mentor employees, providing insights and education on processes and procedures, and conveying QA expectations
• Provide consultation or advice aligned with QA policies through ongoing floor presence, offering QA guidance to events or questions
• Perform activities related to 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 toward continuous improvement
• Investigate and/or participate in microbiological sample investigations
• Gown into cleanrooms and controlled environments

Qualifications

• Associate QA Specialist - 2+ years
• QA Specialist - 4+ years
• Sr QA Specialist - 6+ years

Skills

• Quality-driven mindset
• Understanding of biologics manufacturing operations
• Organized with strong attention to detail
• Ability to prioritize multiple assignments and adapt to changing priorities
• Ability to stand for periods of time on the floor

Education

• Bachelor‚Äôs degree required

Additional Requirements

• On-the-floor presence in cleanrooms and controlled environments