AbbVie Jobs

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AbbVie Quality Engineer III/II in North Chicago, Illinois

Quality Engineer III/II

USA, Illinois, Lake County

New

Quality Assurance

Requisition #2002506

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.

Additional Information

  • Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

  • Travel: No

  • Job Type: Experienced

  • Schedule: Full-time

  • Job Level Code: IC

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