Summary

The Cell & Gene Therapy Quality Control Laboratory within the Department of Pediatrics is seeking a Senior Research Quality Analyst to assist in ensuring compliance with federal and industry Quality Control (QC) guidelines. The position will focus on evaluating various submissions (protocols, Investigational New Drug, Food and Drug Administration, etc.) and maintaining complaiance for ongoing initiatives. 

Job Duties

• Review of FDA guidances to insure CAGT Quality Control Laboratory meets and exceeds new requirements.
• Guiding QC staff in the development of new testing to bring costs in-house and save money.
• Assist PIs and Regulatory Department with questions regarding new protocols, yearly IND reports, CMC (Chemistry, Manufacturing, Controls)testing descriptions/report evaluations,and tracking patient follow-up results for these FDA submissions.
• IATA shipping training required and must ensure all appropriate paperwork is in place before permission to ship is granted. Including but not limited to Material Transfer Agreement between Baylor and recipient, Payment is received and customs paperwork is completed. 
• Review of monthly Quality Control equipment records to evaluate and test results.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• 10+ years working in clean room facilities.
• Familiar with FDA guidances, EU requirements, FACT, CLIA and CAP regulations.
• MT(ASCP) preferred with knowledge of how clinical laboratories run.