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CAPA Specialist II

3 months ago

North Chicago, United States AbbVie Full time

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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
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 applying to a position in any location with pay disclosure requirements under state or local law:

      • The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this postingbased on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more orless than the posted range. This range may be modified in the future.

      • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.

      • This job is eligible to participate in our short-term incentive programs.

        Note: No amount of payis a considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidandmay be modified at the Companys sole and absolute discretion, consistent with applicable law.

        AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.