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This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13551331

The Quality Engineer Associate is responsible for the initiation and completion of process deviations investigations aimed at identification of root cause, and implementation of corrective actions to prevent recurrence. This is a development role to expand the knowledge and technical understanding of the investigator as it relates to risk analysis, root cause assessment, and remediation activities.

Key Responsibilities

• Project management, time management, analytic and related leadership skills.
• Work on the manufacturing floor and across the site for data gathering from various sources.
• Performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation.
• Work closely with the Quality Engineer to develop investigation skills and expand knowledge of pharmaceutical manufacturing.
• Identification of Corrective and Preventative Actions to reduce deviation recurrence.
• Align internal review team and area subject matter experts on an agreed investigational path forward, author investigations and support resolution through experimental DOE and execution.
• Ensures robustness (complete, accurate and defendable) of all critical and major investigations.
• Ensures all CAPAs are implemented through cGMP systems (e.g. MBR revision, training, etc.).
• Monitor and ensure effectiveness checks of CAPAs are conducted Communication and Process Improvements.
• Provide timely updates to management on status of all GMP-related investigations.
• Identifies opportunities for operational improvements for both manufacturing, deviation and investigation management non-conformance events.
• Ownership and implementation of actions related to CAPA, continuous improvement, etc.
• Partner with aseptic operations, post production, and quality to aid in investigations across all functions of the plant.