Quality Assurance Specialist - Pharmaceutical
Location: Houston, Texas
Type: Full time, permanent
Schedule: 100% onsite
- Review and approve procedures, QC data, master batch records, and other QA controlled documentation, and associated change controls.
- Provide on-going support to manufacturing operations, review and approve product-related documentation, including batch records, quality control test results, and certificates of analysis, etc. and perform release of final product, as required.
- Ensure all product-related non-conformances and all associated CAPAs are initiated, investigated, and resolved.
- Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.
- Bachelor's Degree in biological sciences, or related discipline
- Minimum of 2 years of Pharmaceutical Quality Assurance/cGMP Compliance experience (1 year in cell therapy product Quality is highly desired).
- Working knowledge and ability to apply GMPs in conformance to U.S. standards (21 CFR 210/211 and 1271).
- Experience performing batch record review and compilation of batch packages