QA Engineer

• Serve as Quality lead for site Inspection Readiness activities
• Works with the Operations teams to continuously improvement of procedures and process controls
• Support Global Compliance as site host for Internal Audits, Client Audits and Regulatory / HA Inspections
• Supports the Internal Audit program, serving as site point of contact and Quality lead for all Internal Audits
• Coordinates discussions and corroborates with site SMEs to develop robust solutions and deliver comprehensive responses to client Audit observations
• Assists with coordination of activities and compilation of data to complete Annual Product Quality Reports (APQR)
• Supports the Quality Risk Management program
• Performs trending and routine monitoring proactively to identify potential compliance gaps and improvement needs
• Reviews / Approves Continued Process Verification (CPV) reports
• Conduct nonconformance investigations and write/review final reports
• Collaborates with Operations and Quality teams to identify and implement effective CAPAs
• Monitors effectiveness and expected impact on Compliance Metrics
• Establishes, Writes, and revises Standard Operating Procedures
• Assists with Quality related Training

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