Senior QA Associate

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 carrying out tasks related to core job responsibilities by providing quality consultation, auditing and the coordination of projects to maintain and improve the quality of work-related processes.

Responsibilities:

• Carry out job duties, by planning, organizing, and leading study-specific inspections and/or internal system/process-based audits.
• Review raw data, protocols and research reports to assure the quality and integrity of the results as well as compliance to protocols, policies, procedures, and applicable  governmental regulations; and be able to evaluate the potential risk of compliance deficiencies.
• Provide guidance and training on GLP regulations and guidelines to Associate GLP auditors and functional area personnel.
• Assist the Inspection Management group on inspections by regulatory agencies.
• Prepare and present project progress reports to update management and keep the team(s) informed.
• Provide Peer Review and/or approval for Audit Plans, Audit Schedules, and Audit Reports.
• Participate on cross-functional project teams.
• This is an independent quality assurance auditor position. The individual is expected to demonstrate decision-making ability. However, this is a skills-mastering position with supervisory review and oversight.

This role will be a hybrid schedule, onsite at our Lake County Headquarters.

Qualifications

• Bachelor’s degree, preferably in life sciences or engineering.
• Thorough understanding of GLP regulatory standards.
• 2+ years’ experience in function or related fields, such as, toxicology, bioanalytical labora