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Senior Quality Specialist, CAPA II

1 month ago

North Chicago, Illinois, United States AbbVie Full time
Purpose

The purpose of this position is to oversee the plant CAPA Quality System by performing 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.
  • Independently leads complex, high-impact investigations.
  • Ensures all investigations are written according to corporate and site requirements.
  • Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System.
  • Ensures all Quality CAPA goals and metrics are met.
  • Promotes a culture of continuous improvement by identifying problems, conducting root cause analysis, and confirming appropriate implementation of corrections, corrective, and preventive actions.
  • Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plant.
Qualifications
  • Bachelor's degree, preferably in one of the following areas: Biology, Chemistry, or Engineering.
  • 6+ years of experience in the pharmaceutical industry in Manufacturing, Quality, or Engineering.
  • Demonstrates ability to problem-solve and utilize analytical skills.
  • Knowledge of Quality/Compliance management, Regulations, and Standards.