Summary

The Lead Deviation Investigator will be responsible for leading the investigation of manufacturing deviations and driving continuous improvement initiatives resulting from manufacturing deviations. The Lead Deviation Investigator will work with subject matter experts and area owners to drive comprehensive root cause analyses and identify CAPAs. The Lead Deviation Investigator will work cross functionally to meet product release and quality timelines related to the investigations, CAPAs, and continuous improvements.

Job Responsibilities

• Apply technical knowledge and abilities to investigate manufacturing deviations

• Review data and documentation to support investigations

• Participate and drive projects and continuous improvement efforts

• Develop and implement CAPAs from root cause analyses and manufacturing deviations

• Draft GMP documentation including but not limited to SOP’s, Forms, Deviations, CAPAs, change Controls and reports.

• Support Health Authority Inspections

• Maintain department KPIs related to performance and throughout of GMP manufacturing deviations and CAPA

Must Have Qualifications

• BS or MS in scientific related field or equivalent work experience

• 3+  years of experience in Pharma GMP manufacturing environment

• Strong Technical Writing 

• CAPA Investigation and report writing experience