QA Specialist (Visual Inspection & Packaging)

Role Summary

We are currently looking to fill a Quality Assurance Specialist position. This position will support Visual Inspection, Assembly, and Packaging operations performed at Regeneron’s internal Fill/Finish facility. This position will provide floor support during production activities and contribute to establishing/updating procedures and policies to ensure assigned areas are operating to current FDA and International Regulatory Body requirements.

Responsibilities

• Oversee programs to support visual inspection, assembly, and packaging operations at the Drug Product facility.
• Ensure that facilities, equipment, materials, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other Regeneron controls.
• Develop or update, review, and approve SOPs, specifications, and other documents to support drug product operations.
• Execute daily operations, including but not limited to:
  • Providing Quality oversight and guidance during on-the-floor manufacturing
  • Executing daily on-the-floor duties to ensure facilities, equipment, materials, and documentation comply with SOPs and safety standards.
  • Performing quarantine and segregation of material
  • Performing line clearances activities
  • Perform Acceptable Quality Level (AQL).
• Review and approve procedures, documents and records, including but not limited to Batch Production Records, and Protocols.
• Ensure that EBR/Batch Records are complete, accurate, and documented according to written procedure.
• Quality support in electronic batch record designed, review, and approval.
• Author/Review/Approve Quality documents, such as SOPs, Risk Assessments, training materials, training documents, protocols and reports.
• Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Identify and implement continuous improvement opportunities within processes and systems and contribute to the continuous improvement culture.
• Maintain project timelines associated with initiatives to support the evolving business.

Qualifications

• Required: Bachelor's degree in Life Sciences or related field
• Experience aligned to level: Associate QA Specialist – 2+ years; QA Specialist – 4+ years; Sr QA Specialist – 6+ years

Skills

• Visual inspection and color assessment proficiency
• Strong interpersonal and cross-functional collaboration
• Problem-solving abilities and critical thinking
• Excellent organizational skills and ability to follow assignments through to completion
• Ability to work in a fast-paced and dynamic environment
• Quality focus with GMP compliance across area operations

Education

• Bachelor’s degree in Life Sciences or related field

Additional Requirements

• Gowning and cleanroom requirements: full cleanroom attire including gown, hairnet, mask, safety glasses, gloves, booties, and related sanitizing practices
• Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire