SR Specialist, QC Lab General, Fremont CA

**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. Technical and Quality lead for non-routine, new method transfer / validations / qualifications, verifications and technical assessments. Responsible for quality and compliance activities including new test methods, specs, plans, reports, forms, SOPs, etc. with no previous experience within the department. Group representative on equipment qualifications for new and novel technology.

Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new equipment validation. Identifies and implements novel improvements and new ways of thinking toward lab processes and compliance activities. Cross...