QA Specialist II
Job Responsibilities:
- 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 (MBR) 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
Skills:
- 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)
Education/Experience:
- Bachelors.
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