Quality Engineer IV

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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose
The Quality Engineer IV performs as QA specialist in the area of quality assurance oversight of operations, production, process and equipment systems and computer validation as well site specific projects related to process improvement and optimization.

Responsibilities

• Provide Quality Assurance oversight and assessment of operational activities in Production, Compliance, Validations, and Technical Services projects.
• Serve as the QA representative on Validation and Technical Services projects. Liaison to process and equipment validations for QA/QC laboratories, BT, Manufacturing, and Engineering.
• Ensure process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes.
• Review and approve equipment validation documentation (e.g., protocols, deviations, and final reports).
• Support change control activities associated with processes and equipment validations.
• Manage and coordinate QA support for new and existing process equipment validations implementation.
• Provide CSV oversight based on the education and training of the individual.
• Provide support in defining statistical design and analysis for process development, technology transfer, analytical development, process validation and re-qualifications, manufacturing, chemistry and microbiology laboratories, incoming QA, investigations, CAPA’s, compliance, complaints process.
• Support investigations related to process and testing findings.
• Communicate effectively and promptly at all levels of the organization.
• Generate appropriate purchas