QA Analyst

Responsibilities:

• 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.
• 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
• Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems.
• 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.
• Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance resolving issues.

Key Skills:

• Technical.
• Analytical.
• Communication skills.
• Problem-solving skills.
• Creativity.
• Test planning.

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