QA Specialist (On the Floor)

Role Summary

Quality Assurance Specialist on the Bulk Drug Substance QA team. This role performs and leads on-the-floor activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron standards.

Responsibilities

• Represent Quality Assurance in support of deviations, change controls, CAPAs, and related investigations, including involvement in investigation, evaluation, and problem resolution
• Act as QA liaison with external partners to communicate QA policy and procedures and provide input on regulatory communications
• Train and mentor employees, providing insights on processes and procedures and conveying QA expectations
• Provide QA guidance on the floor, consulting with stakeholders to address events or questions
• Dispostion activities for product, including manufacturing record review, document review, and source data review
• Review, edit, or approve Regeneron controlled documents
• Review and approve investigations related to product or processes
• Continuously evaluate Regeneron processes and procedures with a focus on improvement
• Investigate and/or participate in microbiological sample investigations
• Gown into cleanrooms and controlled environments

Qualifications

• Required: Bachelor's degree; 2+ years (Associate QA Specialist), 4+ years (QA Specialist), or 6+ years (Sr QA Specialist) of relevant experience; level determined by qualifications; may substitute proven experience for education
• Preferred: Understanding of biologics manufacturing operations
• Preferred: Strong organization and attention to detail
• Preferred: Ability to prioritize multiple assignments and adapt to changing priorities
• Preferred: Ability to stand for periods of time while performing floor tasks

Education

• Bachelor’s degree