QA Specialist (Visual Inspection & Packaging)

Role Summary

QA Specialist (Visual Inspection & Packaging) supporting Visual Inspection, Assembly, and Packaging operations at Regeneron’s internal Fill/Finish facility. Provides floor support during production activities and helps establish/update procedures to ensure operations meet current FDA and international regulatory requirements.

Responsibilities

• Oversee programs to support visual inspection, assembly, and packaging operations at the Drug Product facility.
• Ensure facilities, equipment, materials, processes, and procedures comply with GMP, GDP, safety, and Regeneron controls.
• Develop or update, review, and approve SOPs, specifications, and other documents to support drug product operations.
• Execute daily operations, including:
  • Providing quality oversight during on-the-floor manufacturing
  • Ensuring facilities, equipment, materials, and documentation comply with SOPs and safety standards
  • Performing quarantine and segregation of material
  • Performing line clearance activities
  • Performing Acceptable Quality Level (AQL) activities
• Review and approve procedures, documents, and records, including Batch Production Records and Protocols.
• Ensure EBR/Batch Records are complete, accurate, and documented per written procedures.
• Provide quality support in electronic batch record design, review, and approval.
• Author/Review/Approve quality documents (SOPs, RA, training materials, protocols, and reports).
• Support and represent QA during audits and inspections; may interact with regulatory agencies during on-site inspections.
• Identify and implement continuous improvement opportunities within processes and systems.
• Maintain project timelines for initiatives supporting evolving business needs.

Qualifications

• Required: Bachelor’s degree in Life Sciences or related field. Level determined by qualifications:
  • Associate QA Specialist – 2+ years
  • QA Specialist – 4+ years
  • Sr QA Specialist – 6+ years
• May substitute proven experience for education requirement.

Education

• Bachelor’s degree in Life Sciences or related field (required). May substitute proven experience for education.

Additional Requirements

• Gowning and Environment: Full cleanroom attire and related requirements; ability to remove jewelry, makeup, and nail adornments when in cleanroom attire.
• Role prerequisites include passing a visual acuity exam (color assessment) and completing the visual inspection training/qualification program; strong interpersonal, problem-solving, organizational, and cross-functional collaboration skills; ability to work in a fast-paced environment; apply GMP knowledge to ensure quality and compliance.