Senior Analyst, Quality Engineering (On-site)

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

Primarily responsible for quality assignments related to batch records, quality approvals, exception
reports, metrics, and other documentation.

Responsibilities:

• Review/approve/release batch record packets and associated documentation
• Provide quality approvals of materials in the materials management system as defined by procedures
• Write/review/approve exception documents and corrective actions/preventive actions (CAPA) and ensure they meet timeliness requirements
• Review/approve clinical documentation and specifications, as applicable
• Write/review/approve policies/processes/procedures and related documents
• Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, R&D GxP Compliance
• Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues
• Generate, analyze and report quality metrics to management
• Lead/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

This role will be onsite 5 days a week at our North Chicago location.

Qualifications

• Bachelor's degree or equivalent experience is required, preferably in life sciences or engineering
• 6+ years’ experience in Quality Assurance or related field, preferred healthcare industry or experience in quality function
• Strong understanding of US and international regulations for quality systems and compliance
• Experience in co