QA Validation Specialist (Fill Finish)

Role Summary

QA Validation Specialist (Fill Finish) role focusing on ensuring equipment, systems, and processes meet regulatory standards within the Fill Finish facility. Located in Rensselaer, NY, with responsibilities spanning qualification, validation, and collaboration across departments.

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).
• Present in a ‚Äúpressure test‚Äù scenario the technical area they are SME for.
• Stay current with industry trends, regulatory requirement updates, and motivate changes and improvements based on trends.
• Generate, implement and/or review master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable 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.
• 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.
• QA Validation Specialist: 2+ years
• Sr QA Validation Specialist: 5+ years

Skills

• Independent work capability and teamwork
• Transparent communication
• Information gathering and organization
• Effective time management
• Continuous improvement mindset

Education

• Bachelor‚Äôs degree in Engineering, Chemistry, or Life Sciences

Additional Requirements

• Gowning and cleanroom environment compliance (full cleanroom attire and related protocols)