Specialist, CAPA II

AbbVieTempe, AZ
$78,500 - $141,000

About The Position

Oversees the plant CAPA Quality System by performing root cause investigations for exceptions/nonconformances/deviations to required procedures and/or specifications for drug product manufacturing and packaging.

Requirements

  • 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

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 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

Benefits

  • paid time off (vacation, holidays, sick)
  • medical/dental/vision insurance
  • 401(k)
  • short-term incentive programs
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