QA Specialist II

• Ensure compliance with GMP, ISO, and regulatory requirements across manufacturing operations
• Review and approve GMP master documents and executed records (e.g., batch records, QC documents)
• Support investigations, deviations, and CAPA (Corrective and Preventive Actions)
• Perform QA walkthroughs and provide on-the-floor quality oversight
• Collaborate with manufacturing, QC, and support teams to resolve quality issues
• Review Master Batch Records (M ) and supporting documents for batch disposition
• Approve/release materials such as buffers and media when required
• Track and maintain quality records and ensure proper documentation practices (GDP)
• Support change control processes and validation-related activities
• Identify compliance gaps and recommend improvements
• Ensure adherence to safety and quality standards in all operations

• Strong knowledge of GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)
• Familiarity with ISO quality systems and global regulatory requirements (US/EU)
• Experience in biopharmaceutical or biologics manufacturing environments
• Understanding of CAPA, deviations, and change control processes
• Knowledge of equipment, facilities, and utilities validation
• Ability to review and interpret batch records and quality documentation
• Proficiency in quality management systems (QMS)

Bachelors.