Sr Specialist/Principal Specialist, QC Lab General, Fremont CA

Job description

Description Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Raw Materials/Cleaning validation/verification. Performs duties under limited supervision and according to standard operating and QC procedures. Scientific and Quality lead for implementing novel methodologies and technologies within the site and global network. Group representative on new or complex equipment qualifications with impacts to global QC systems (e.g. Empower, LIMS, etc.). Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new equipment validation. Serves as a QC subject matter expert (SME) for critical processes with interdisciplinary impact on the site wide and global level. Change agent accountable for identification of novel processes or approaches that can improve QC methods or compliance. Responsible for concept design, strategy, and implementation of novel processes and technologies. Cross functional team lead that independently handles complex deviations, OOS, investigations, CAPAs and change controls that impact multi...