Description

Lead deviation triage, investigations, and closure in a regulated cGMP manufacturing environment. This role is on-site.

Responsibilities

• Facilitate triage, investigations, and CAPA record closure within the electronic quality management system.
• Review technical data to determine corrective actions and prevent incident recurrence.
• Ensure deviation and investigation reports meet regulatory expectations for technical merit and completeness.
• Manage deviations to achieve right-first-time results and meet phase completion due dates.
• Work cross-functionally to support routine clinical and commercial product release timelines.

Required Skills

• 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals.
• Minimum 4 years managing deviations and CAPA within quality systems.
• Proficiency with Root Cause Analysis (RCA) methodologies.
• Experience working within cGMP environments and adhering to FDA/EMA regulations.
• Strong computer skills using Word, Excel, and electronic manufacturing systems.
• Proven ability to evaluate information critically and determine appropriate courses of action.
• Excellent written and verbal communication skills for technical reporting.

Preferred Skills

• Experience with Six Sigma or Kaizen methodologies to improve process and product quality.
• Bachelor’s degree in a science or engineering discipline.

Key Skills

Education

Any Graduate