The Quality Engineer will be responsible for the initiation and completion of process deviations investigations aimed at identification of root cause, and implementation of corrective actions to prevent recurrence.
• Strong 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.
• 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
• 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.
• Clock in and out for every scheduled shift in a timely manner.
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Set Yourself Apart: Profile/Experiences
• Bachelor of Arts/Science preferably in Biochemistry, Chemical Engineering, Biology or other relevant
• 2-4 years’ deviation investigation experience in a manufacturing environment preferred.
• Strong technical writing capability including efficiency using Microsoft Office Suite.
• Familiarity with cGMP working environment and quality systems.
• Ability to manage multiple ongoing projects concurrently.
• Strong meeting facilitation and conflict resolution skills.
• Participation in the Daily Management meetings to update leadership on deviation statuses.
• Analytical and problem-solving skills.
• Flexible and able to adapt to company growth and evolving responsibilities.