Valentina Gonzalez

Senior Quality Control Associate @Sarepta Therapeutics

Performing routine and non-routine analytical tests of custom raw material per cGMP for release and stability samples using HPLC, GC, KF and other general laboratory techniques • Review LC, LC/MS, GC, KF and other general laboratory data generated per cGMP for reference material samples. • Assist in writing and reviewing quality documents such as test methods, SOP, OOS/OOT and CAPA originated internally as well as at the vendor sites. • Create and maintain clear and concise lab records and documentation • Assist in transferring methods to and from vendor sites and their troubleshooting. • Monitor, review, and trending of reference material re/qualification data. • Manage activities related to reference standard qualification and supply to external sites, including inventory management and shipping. • Assist in writing internal validation protocols, reviewing validation reports for LC, LC/MS, GC, and other analytical methods • Execution of laboratory experiments, review of analytical data and authorization of final reports