Principal QA Validation Specialist – Aseptic Fill Finish
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Albany, NY, USA |
| Salary | $77600 – $173400 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- BS/BA in Engineering, Chemistry, or Life Sciences
- 5+ years of experience for Sr QA Validation Specialist
- 8+ years of experience for Principal QA Validation Specialist
- 10+ years of experience for Staff QA Validation Specialist
- Ability to maintain integrity and honesty at all times
- Ability to work independently or as part of a team
- Ability to communicate with transparency
- Effective time management skills
- Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Responsibilities
- Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions
- Lead and drive projects and programs
- Present project and program status and metrics to Senior Management
- Act as Technical Subject Matter Expert (SME) in at least one area
- Stays current with industry trends, regulatory requirement updates, and motivates changes and improvements based on trends
- 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
- Coordinates with other departments or outside contractors/vendors to complete validation tasks
- Collaborates with functional departments to resolve issues
- Trains/advises 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 prepares status reports
- May present at both internal and external (regulatory) audits
- Stays current with industry trends, regulatory requirement updates, and communicating same to team
- May manage full time employees and/or contingent workers
- Performs other duties assigned by Management
Preferred Qualifications
- Ability to gather and organize information
- Meets commitments on time
- Performs well-defined tasks
- Seeks to identify continuous improvement needs