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QA Manager - Operations
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- Responsible for compliant, thorough, and accurate batch review activities, including QC analytical data and other ancillary batch documentation.
- Perform batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control and investigation
- Oversees material and product label printing and ensuring regulatory requirements are being met.
- Ensures that critical materials used in the manufacture of cellular immunotherapies and gene therapies, are sourced appropriately, received and tested according to approved standards,and provides the disposition of these materials.
- 5+ years of experience in Quality Assurance with demonstrated leadership skills, and a strong focus in GMP Quality
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