QA Specialist (Batch Record Reviewer)

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Responsibilities

• Reviewing and release of semi-finished and finished drug product.
• Ensuring adherence to Standard Operation Procedures and current Good Manufacturing Practices.
• Quarantine and monitor product on hold and preparing required batch disposition documentation for international sites as required.
• Performing the Quality Assurance review and release of semi-finished product, validation, media, and final products.
• Review batch records to support product release schedule, ensuring regulatory compliance, customer satisfaction and delivery of products.
• Quarantine and monitor product in “on hold” status prior to disposition.
• Prepare required batch disposition documentation and provide to international markets as required to ensure current Good Manufacturing Practices compliance.
• Identify and resolve all batch record discrepancies to prevent a regulatory impact.
• Assist department supervisors in maintaining dispositioned batch records to provide an efficient and secure storage and retrieval process.
• Perform all Final Product disposition following global SOPs for release in SAP.
• Exercise independent judgement in every batch based on evidence provided (e.g., CAPAs and their effectiveness).
• Perform Quality Assurance checks of all batch related documents for manufacturing, production, validation, and quality assurance departments.
• Responsible for the final sign‑off of the product being released to the market.
• Ability to exercise independent judgement and critical thinking.

Qualifications

• Bachelor’s Degree in the Sciences or technical field or equivalent experience.
• 5 years of experience in a quality role or experience handling and reviewing documentation records.
• Intermediate Microsoft Word and Microsoft Excel skills.
• SAP experience preferred.
• 3 years of experience in a GMP Environment.
• Prefer experience in an aseptic manufacturing environment.
• Working knowledge of Quality Assurance systems, cGMP’s, ISO 13485, CMDRs, and EMEA regulations preferred.
• Competency utilizing Electronic Systems ie. Maximo and Trackwise for Quality checks.

Skills

• Intermediate Microsoft Word and Microsoft Excel.
• SAP.
• Quality Assurance systems, cGMP, ISO 13485, CMDRs, EMEA regulations.
• Electronic systems: Maximo, Trackwise.
• Independent judgement and critical thinking.

Benefits

• Paid time off (vacation, holidays, sick).
• Medical/dental/vision insurance.
• 401(k) plan.
• Short‑term incentive programs.