QA Specialist (Batch Record Reviewer)

Quality assurance specialist responsible for reviewing and releasing semi-finished and finished pharmaceutical products while ensuring compliance with manufacturing standards and regulations. Role involves batch record analysis, documentation preparation, and product disposition for domestic and international distribution.

Responsibilities

• Review and release semi-finished products, validation media, and final pharmaceutical products
• Analyze batch records for regulatory compliance and timely product delivery
• Quarantine and monitor products on hold status; prepare disposition documentation
• Identify and resolve batch record discrepancies to prevent regulatory issues
• Exercise independent judgment and critical thinking in batch release decisions

Requirements

• Bachelor's degree in sciences or technical field, or equivalent experience
• Five years quality role experience or documentation record review experience
• Three years experience in GMP environment
• Intermediate Microsoft Word and Excel skills; SAP experience preferred
• Knowledge of cGMP, ISO 13485, CMDR, and EMEA regulations preferred
• Aseptic manufacturing environment experience preferred
• Competency with electronic quality systems such as Maximo and Trackwise