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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Quality Engineer III/II

Quality Assurance
2002506 Requisition #
Join our Talent Community
Key Responsibilities:
  • Review/approve batch record packets and associated documentation.
  • Provide quality approvals in materials management system as defined by procedures.
  • Write/review/approve exception documents and corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
  • Review/approve clinical documentation and specifications, as applicable.
  • Write/review policies/processes/procedures and related documents.
  • Assist in the preparation of audits conducted by regulatory agencies, customers and GxP Compliance.
  • Actively participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues and take preventive actions.
  • Generate and report quality metrics to management.
  • Participate with support groups in developing/prioritizing QA activity timelines.
  • Actively monitor the effectiveness of processes and quality of project work with management, and propose and execute quality/process improvements.
Minimum Education Requirements:
  • Bachelor’s degree or equivalent experience is required; typically in life sciences or engineering

Minimum Experience Required:
  • 2+ years experience in pharma industry. 1 – 2 years experience in Quality Assurance or related field.  Preferred healthcare industry and specific experience in quality function.
  • General understanding of US and international regulations for quality systems and compliance.
  • Experience in coordination and planning of activities. Demonstrated organizational skills.
  • Interpersonal and team negotiation skills to handle multiple priorities.
  • Ability to build and maintain credibility across functional disciplines.
  • Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.
  • Ability to identify and resolve quality issues through effective use of technical and interpersonal skills.
  • Ability to demonstrate and model all core competencies.

Other requirements, if applicable:
  • Accreditation by a professional body is highly desirable. 
  • Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).

Please Note: Level of position is flexible based on years of experience.

Equal Employment Opportunity Employer

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.  As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.

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