Associate QA Validation - Cleanroom Equipment

Regeneron Pharmaceuticals Inc.; New York (NY); Presencial; USD 62.000 - 92.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals Inc. seeks an Associate QA Validation Specialist to validate and qualify equipment, systems and processes in line with regulatory requirements and company standards; this role focuses on the cleaning validation team.

A typical day includes generating and reviewing qualification protocols and reports, analyzing results, investigating issues, coordinating with other departments and vendors, and possibly supervising staff; travel may be required.

Formación

• BS/BA in Engineering, Chemistry, or Life Sciences required.
• 0–2 years for Associate, 2+ years for Specialist, 5+ years for Senior Specialist, 8+ years for Principal Specialist.
• May substitute proven experience for education requirement.

Responsabilidades

• Generate/review qualification and validation protocols and reports.
• Analyze testing results against criteria.
• Investigate issues and propose improvements.
• Review/approve deviation notices, investigations, CAPAs, change controls, SOPs and reports.
• Coordinate with other departments and vendors to complete tasks.
• May supervise/assign work to staff.
• Prepare status reports and manage projects.
• Present at internal and regulatory audits.
• Other duties as assigned.

Conocimientos

MS Office

Communication

Teamwork

Time management

Problem solving

Integrity

Educación

BS/BA in Engineering, Chemistry, or Life Sciences

Herramientas

Microsoft Office

Descripción del empleo

Regeneron Pharmaceuticals Inc. seeks an Associate QA Validation Specialist to validate and qualify equipment, systems and processes in line with regulatory requirements and company standards; this role focuses on the cleaning validation team.

A typical day includes generating and reviewing qualification protocols and reports, analyzing results, investigating issues, coordinating with other departments and vendors, and possibly supervising staff; travel may be required.