CAPA Specialist II

Company Description 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. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose Oversees the plant CAPA System under Operations by performing root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for 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 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 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 Additional Information Applicable only to applicants