CAPA Specialist I

4 weeks ago


North Chicago, Illinois, United States AbbVie Full time

Job Summary

AbbVie is seeking a Regulatory Investigator to perform root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for drug product manufacturing and packaging.

Key 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

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.



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