Regeneron's Fill Finish QA Validation team needs a Senior QA Validation Specialist to ensure equipment, systems, and processes meet regulatory standards while adhering to company manufacturing policies and procedures at their Fill Finish facility in Rensselaer, NY
Requirements
- BS/BA in Engineering, Chemistry, or Life Sciences
- 2+ years of experience for QA Validation Specialist
- 5+ years of experience for Sr QA Validation Specialist
- Ability to work with equipment such as Syringe and Vial Fillers, Lyophilizer, Semi-Automatic and Automatic Inspection, Assembly Machines, Packaging Machines, Serialization, Case Packer and Palletizer
- Knowledge of regulatory requirements and industry trends
- Ability to present in a 'pressure test' scenario the technical area they are SME for
Responsibilities
- Monitor compliance, analyze failures, and assess corrective actions
- Presents project and program status and metrics to Senior Management
- Act as Technical Subject Matter Expert (SME) in at least one area (e.g. Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control)
- Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions
- Reviews, edits and approves change controls, SOPs, reports and other documentation
Other
- Ability to work independently or as part of a team
- Ability to communicate with transparency
- Gathers and organizes information
- Effective time management skills
- Seeks to identify continuous improvement needs
