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AD QA Ops

2 months ago


Portsmouth, United States Lonza Full time
Key Responsibilities:

Leads the overall quality strategy within the asset

.• 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 customer Quality Agreements, Lonza SOPs, and regulatory requirements.

• Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.

• Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings.

• Attends Site Quality Council and Lot Disposition meetings

.• Managesand tracksKey Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management. Performs Lot Release/Disposition activities

.• Identifies and implements improvements to quality processes.

• Provides general direction for department. Develops team goals, monitors progress and ensures continuous improvement.