Specialist, CAPA I

Role Summary

Performs root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for drug product manufacturing and packaging.

Responsibilities

• Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements
• Coordinates the exception document process and creates exception documents
• Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions
• Ensures all investigations are written according to corporate and site requirements
• Participates in implementation and maintenance of the Quality System to meet all applicable regulatory requirements
• Effectively collaborates/partners with other Quality areas and departments within the plant

Qualifications

• Bachelor's degree, preferably in one of the following areas: Biology, Chemistry or Engineering
• 4+ years of experience in the pharmaceutical industry in Manufacturing, Quality or Engineering
• Ability to problem solve and utilize analytical skills
• Knowledge of Quality/Compliance management, Regulations and Standards