Position Summary
The Specialist, Quality Control Analytical will serve as Subject Matter to advise testing laboratories on method development, method validation, method transfer, and quality investigations. Primary duties will include data review and troubleshooting of analytical test methods.
Essential Functions
Author, review and revise documentation (SOPs, test methods, analytical method development, method validation, method transfer protocols/ reports, product specifications)Review QC stability and lot release data (data integrity check) and CoAs issued by contract testing laboratories and create batch release certificate of analysisAuthor and review laboratory OOS investigation and invalid laboratory test result, including filing internal Quality Systems reports as applicable.Issue ImmunityBio release Certificates of Analysis (CoAs) to support QA lot disposition activities.Author, review and revise An...