QA Specialist – Batch Record Review

About the role

The QA Specialist is responsible for reviewing and dispositioning batch records for bulk and finished drug products, ensuring compliance with AbbVie policies, regulatory requirements, and current Good Manufacturing Practices (cGMP). The role works closely with Quality Assurance, Production, Engineering, and other functions to guarantee product quality and release.

Key responsibilities

• Audit electronic and manual batch records for API, bulk, and finished drug products against GMP, policies, and procedures.
• Identify and evaluate discrepancies, determine corrective actions, and approve MES exceptions related to production support.
• Track and trend batch record discrepancies, collaborating with other departments to reduce errors.
• Provide timely disposition of manufactured products in the SAP system based on testing results and regulatory requirements.
• Prepare Certificates of Analysis, Certificates of Compliance, and enter batch information into the lot restriction management system.
• Assemble batch record review packages, support annual product quality reviews, and generate reports for Right the First Time, release cycle time, and regulatory audits.
• Participate in weekly shop‑floor control meetings to discuss batch record status and potential release impacts.
• Ensure compliance with environmental, health, and safety (EHS) procedures and promote continuous improvement.

Required profile

• Bachelor’s degree in a scientific discipline such as Biology, Chemistry, Biotechnology, or Engineering.
• Experience with batch record review, GMP compliance, and pharmaceutical manufacturing processes.
• Familiarity with regulatory agency requirements and product release procedures.

Required skills

• Proficiency with SAP for batch disposition.
• Knowledge of Manufacturing Execution Systems (MES) and their exception handling.
• Strong understanding of cGMP principles and regulatory compliance.
• Experience with lot restriction management systems.

What we offer

• Opportunity to work within a global biopharmaceutical leader.
• Collaborative environment focused on innovation and patient impact.