Quality Assurance Manager
6 days ago
The Quality Assurance Manager at Lonza leads a team of QA Compliance/Operations Specialists responsible for supporting internal and external customers. This position ensures staff meets objectives and deliverables on time and in full, and plays a key role within the site leadership team.
Key Responsibilities
Provides general direction and support to QA staff and customers.
Ensures objectives are met and expectations align with Lonza SOPs and regulatory requirements.
Partners with internal customers to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
Reviews and approves documents such as SOPs, Work Instructions, Forms & Checklists, and Validation / Qualification documents.
Attends Change Control Committee, Deviations Review Board, and CAPA Board meetings as needed.
Manages and tracks Key Performance Indicating Quality Metrics, including batch release information for senior site management.
Requirements
A Bachelor's Degree with 3 years exposure to a GMP regulated environment is required for this position.
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