Investigation Specialist - Deviation & CAPA Expert

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks Investigation Specialists to join deviation investigation teams in Rensselaer, NY. These roles handle compliance tasks to complete investigations and implement robust corrective actions for manufacturing operations.

Positions involve independent non-conformance investigations, preparing detailed reports with recommendations, and reviewing batch records under cGMP standards to ensure quality and compliance.

Qualifications

• BS in life sciences, engineering or related field (may substitute proven experience)
• 2+ years of relevant investigation experience for base level
• Senior level requires 5+ years of experience (level determined by experience)

Responsibilities

• Independently investigating non-conformances and preventing reoccurrences in support of manufacturing operations
• Preparing investigation reports with recommendations for medium/high severity non-conformances
• Analyzing and evaluating information captured through investigations; summarizing trends in reports
• Reviewing batch records and logbooks in accordance with cGMP standards to support investigations
• Reviewing, editing, and revising controlled documents to ensure compliance with procedures
• Monitoring production processes to acquire data and track efficiency of changes
• Participating in and/or leading cross-functional study teams to drive results and investigations
• Gathering and trending process-related data to drive consistency and timeliness

Skills

Investigations

cGMP compliance

Data analysis

Education

Bachelor's degree in life sciences or engineering

Job description

Regeneron Pharmaceuticals, Inc. seeks Investigation Specialists to join deviation investigation teams in Rensselaer, NY. These roles handle compliance tasks to complete investigations and implement robust corrective actions for manufacturing operations.

Positions involve independent non-conformance investigations, preparing detailed reports with recommendations, and reviewing batch records under cGMP standards to ensure quality and compliance.