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QA Specialist II – QA Operations, Onsite - Houston, TX, Night Shift :
Job Summary:
QA Specialist II – QA Operations, Onsite - Houston, TX, Night Shift :
Job Summary:
- Ensure company compliance with ISO/GMP quality system requirements and relevant regulatory guidance.
- Provide oversight and ensure compliance for CAPA (Corrective and Preventive Actions) and minor deviations.
- Perform QA walkthroughs on the manufacturing floor; collaborate with manufacturing and support teams to resolve issues.
- Support QA presence and execution on the production floor for ongoing operations.
- Review and approve GMP master documents and executed GMP documents from various departments (QC, manufacturing, material management, etc.).
- Review Master Batch Records (MBR) and supporting documents for batch disposition; responsible for review/release of buffer/media as required.
- Track quality records and ensure overall cGMP (current Good Manufacturing Practice) compliance.
- Support and participate in investigations using problem-solving tools; assist with corrective actions and change controls.
- Participate in equipment, facility, and utilities validation activities.
- Perform other QA duties as assigned.
- Apply strong knowledge of Good Documentation Practices (GDP).
- Work a third shift schedule: Sunday to Thursday, 11pm to 8am.
- Required experience in biopharmaceutical manufacturing and understanding of EU/global regulations.