QA Validation Specialist (Fill/Finish)
Regeneron
Full-time
On-site
East Greenbush, NY
Operations
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Role Summary
QA Validation Specialist (Fill/Finish) for Regeneron’s Fill Finish QA Validation team. Ensure equipment, systems, and processes meet regulatory standards while adhering to manufacturing policies and procedures. Supports the Fill Finish facility in Rensselaer, NY.
Responsibilities
- Monitor compliance, analyze failures, and assess corrective actions.
- Present 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).
- Present in a “pressure test” scenario the technical area they are SME for.
- Stay current with industry trends, regulatory updates, and motivate changes and improvements based on trends.
- Generate, implement and/or review master and completed qualification and validation protocols, summary reports, and data for conformance to regulations, SOPs, specifications, and acceptance criteria.
- Analyze testing results and determine acceptability against pre-determined criteria.
- Review, edit, and approve deviation notifications, deviation investigations, and corrective actions.
- Review, edit, and approve change controls, SOPs, reports, and other documentation.
- Coordinate with other departments or outside contractors/vendors to complete validation tasks.
- Collaborate with functional departments to resolve issues.
- Manage and drive projects and prepare status reports.
- May present at internal and external (regulatory) audits.
Qualifications
- BS/BA in Engineering, Chemistry, or Life Sciences (or equivalent); 2+ years for QA Validation Specialist or 5+ years for Senior QA Validation Specialist.
- May substitute proven experience for education; level determined by qualifications relevant to the role.
Skills
- Independent or team-based work capability
- Transparent communication
- Information gathering and organization
- Effective time management
- Continuous improvement mindset
Education
- BS/BA in Engineering, Chemistry, or Life Sciences (as noted above in Qualifications).
Additional Requirements
- Gowning and cleanroom environment requirements: full cleanroom attire and removal of jewelry, makeup, and nail adornments when in cleanroom attire.
- On-site work policy considerations as determined by Regeneron.