QA Specialist
Contract Independent
Contract W2
Contract Corp To Corp
No Travel Required
On-site
Depends on Experience
DCode Talent
Fitment
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Job Details
Skills
- QA Specialist
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.
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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 91166691
- Position Id: 452-43174-
- Posted 11 hours ago
Company Info
About DCode Talent
At Dcode Talent, we specialize in IT staffing and consulting services, connecting skilled professionals with top companies. Our expertise spans across multiple industries, ensuring that businesses find the right talent and IT professionals achieve their career goals.
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