Investigation Specialist

Regeneron Pharmaceuticals•Rensselaer, NY

5d•$62,355 - $110,000•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re seeking Investigation Specialists to join our teams in internal fill finish& global manufacturing. These positions perform all compliance related tasks vital to completing investigations and implementation of robust corrective actions for supporting manufacturing operations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

B.S in life sciences, engineering or related field; may substitute proven experience for education requirement
0-2+ years of experience (for Associate Investigation Specialist)
2+ years of experience (for Investigation Specialist)
5+ years of experience (for Senior Investigation Specialist)

Responsibilities

Independently investigating non-conformances and preventing reoccurrences in support of manufacturing operations
Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
Participating in and/or leading cross-functional study teams to get results, support and or author investigations
Gathering, trending, and analyzing process related data to drive consistency and timeliness