CAPA Specialist

CAPA specialist

Responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings

Job Description

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.

• Independently produces and completes CAPA records.

• Responsible for performing timely, detailed CAPA tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.

• Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.

• Represent CAPAs during audits and CAPA Review Board meetings.

• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).

• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.