Sr QA Validation Specialist (Fill Finish)
Regeneron
Full-time
Remote friendly (East Greenbush, NY)
United States
Operations
Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Sr QA Validation Specialist (Fill Finish) responsible for ensuring equipment, systems, and processes meet regulatory standards while adhering to manufacturing policies. Support for 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 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 and regulatory updates; motivate changes 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 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.
- Train/advice less experienced Specialists.
- May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
- Manage and drive projects and prepare status reports.
- May present at internal and external (regulatory) audits.
- May manage full-time employees and/or contingent workers.
- Performs other duties assigned by Management.
Qualifications
- BS/BA in Engineering, Chemistry, or Life Sciences
- 2+ years for QA Validation Specialist; 5+ years for Sr QA Validation Specialist
- May substitute proven experience for education requirement; level determined by qualifications
Skills
- Independent work style and team collaboration
- Strong communication and transparency
- Information gathering and organization
- Effective time management
- Continuous improvement mindset
Education
- BS/BA in Engineering, Chemistry, or Life Sciences
Additional Requirements
- Gowning and cleanroom environment requirements
- Regulatory audit participation may be required