QA Validation Specialist (Fill/Finish)

Role Summary

QA Validation Specialist (Fill/Finish). Our Fill Finish QA Validation team is hiring. As the QA Validation Specialist, you will ensure equipment, systems, and processes meet regulatory standards while adhering to company manufacturing policies and procedures. This role will support our Fill Finish facility in Rensselaer, NY.

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).
• Must be able to present in a “pressure test” scenario the technical area they are SME for.
• 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.
• Manage and drives projects and prepares status reports.
• May present at both internal and external (regulatory) audits.

Qualifications

• To Be Considered For This Position, You Must Hold a BS/BA In Engineering, Chemistry, Or Life Sciences.
• QA Validation Specialist: 2+ years; Sr QA Validation Specialist: 5+ years.
• May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Skills

• Are able to work independently or as part of a team.
• Have ability to communicate with transparency.
• Can gather and organize information.
• Have effective time management skills.
• Seek to identify continuous improvement needs.

Education

• BS/BA in Engineering, Chemistry, or Life Sciences (required).

Additional Requirements

• Gowning and Environment: Full cleanroom attire including gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and sanitizing agents; remove jewelry, makeup, and nail adornments when wearing cleanroom attire.