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    Specialist Distribution Quality Assurance - North Chicago, United States - AbbVie

    AbbVie
    AbbVie North Chicago, United States

    1 month ago

    Default job background
    Full time
    Description

    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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Job Description

    Purpose

    Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations. Assure compliance with Corporate policies/procedures and provide guidance on operational processes, procedural issues and documentation content and adequacy.

    Assess operations/distribution outages and deviations to determine compliance with specifications and procedures.

    Responsibilities

  • Approve/initiate changes to Distribution Operations and QA procedures, facility and equipment
  • Audit Interface- FDA, supplier, customer inspection, corporate
  • Conduct product quality, diversion and distribution complaint investigations
  • Manage warehouse temperature monitoring program
  • Initiate exceptions reports in the appropriate database
  • Perform inbound quality inspections and usage decision
  • Execute domestic and international sales/recall reports
  • Execute placement and removal of QA Holds in warehouse management system
  • Manage/Post supplier audit data in appropriate database
  • Manage market authorization process and Material Data Management

    Qualifications
  • High school degree is required. Bachelor's degree is preferred
  • 2-4 years in Quality Assurance, Process Support, Manufacturing, Distribution, Quality Control or similar area.
  • Reviewing problem solving situation
  • Understand manufacturing / distribution process
  • Product responsibility for compliance troubleshooting
  • Audit interface
  • Creativity in resolving issues
  • Negotiation skills with Mfg. / Distribution customers

    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 in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less 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/vision insurance and 401(k) to eligible employees.​
  • This job is eligible to participate in our short-term incentive programs. ​

    Note: No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's 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 AbbVie's 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.

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