QA Analyst

Responsibilities:

• Provides general direction and support and acts as a point of escalation for QA staff and customers.
• Ensures objectives are met and expectations align with Lonza SOPs, and regulatory requirements.
• Present and defend the Cleaning Validation program and acceptance criteria to Clients and Regulators.
• Review and revise the Cleaning Validation Master Plan as necessary to ensure GMP compliance with all applicable regulations and guidelines.
• Utilizing an identified standard, independently review and approve in a Document Management System initial version and revised documents such as SOPs, Work Instructions, Forms & Checklists, Scanned Documents and others as needed.
• Review and approve electronic and/or paper Validation / Qualification documents such as Protocols & Summary Reports for
• Attends Change Control Committee, Deviations Review Board and CAPA Board meetings as needed.
• Attends Site Quality Council and Lot Disposition meetings Quality Leadership meetings.
• Manages and tracks Key Performance Indicating Quality Metrics including batch release information for senior site management.

Key Skills:

•  Quick Learner.
•  Meticulous.
•  Analytical.
• Good Coaching.
• Verbal Communication.
•  Good Written.
• Communication.
•  Empathetic