QA Specialist (On the Floor)

Role Summary

QA Specialist (On the Floor) — You will perform and lead on-the-floor quality assurance activities to support dispositioning of product and/or raw materials, ensuring compliance with QA policies, cGMPs, SOPs, and Regeneron standards.

Responsibilities

• Represent Quality Assurance in support of deviations, change controls, CAPAs, and related investigations, evaluations, 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, providing insights on processes and procedures and conveying QA expectations.
• Provide continuous on-the-floor QA guidance to events or questions by working with stakeholders.
• Perform disposition 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 for improvement.
• Investigate and/or participate in microbiological sample investigations.
• Gown into cleanrooms and controlled environments.

Qualifications

• Required: Bachelor's degree and 4+ years of relevant QA experience for QA Specialist level; 6+ years for Sr QA Specialist; 2+ years for Associate QA Specialist.
• May substitute proven experience for education requirement. Level determined by qualifications relevant to the role.

Skills

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

Education

• Bachelor’s degree required (specific field not stated).

Additional Requirements

• On-the-floor work environment; gowning into cleanrooms and controlled environments.
• Shift: Wednesday-Saturday, 3rd shift: 10pm-08:30am.