Quality Compliance - Internal Auditor

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

Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards and responsible for assisting in Annual Product Reviews.

Responsibilities

• Assists with planning and conducting internal compliance audits of all operations within the facility. Helps the team to become more proactive in preparing for audits.
• Provides support with company and regulatory agency (i.e. DEA, FDA) inspections.
• Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Assist with management review and associated metrics for the plant. Creates compliance performance metrics.
• Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s).
• Responsible for supplier qualifications including new suppliers, changes and re-qualifications.
• Builds internal auditing process.
• Updates documentation to ensure it is up to date and compliant with standards.
• Responsible for assisting in Annual Product Reviews.
• Other duties as assigned.

Qualifications

• Bachelor’s Degree required, preferably in Science or Engineering.
• 5+ years of experience in a cGMP related industry or clinical setting preferred.
• Quality Assurance/Regulatory Affairs/Compliance is preferred
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA)
• Some knowledge of plant and company level procedures preferred.
• Ability to evaluate quality, production