
Website Regeneron
Job Description:
We are currently looking to fill an Investigation Specialist position. This position performs all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations.
Job Responsibilities:
- Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
- Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
- Participating in and/or leading cross-functional study teams to get results, support and or author investigations
- Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
- 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
- Communicating findings and recommendations at group meetings
Job Requirements:
- Can prioritize multiple assignments and changing priorities
- Have an understanding of biologics manufacturing operations
- Are able to learn and utilize computerized systems for daily performance of tasks
- Are organized and have an attention to detail
- Excel in a quality driven organization
Job Details:
Company: Regeneron
Vacancy Type: Full Time
Job Location: Albany, NY, US
Application Deadline: N/A
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