Responsible for clinical and commercial lot file review, testing of incoming raw materials, sampling, labeling tracking and shipping of samples. Perform review of clinical and commercial QC Lot Files Perform review of Raw Material Lot Files Provide oversight and accountability of the QC Lot File process for the following: Support document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts. Perform other tasks as assigned. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Apply scientific principles to analytical testing and the proper use of laboratory equipment. Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs. Attention to detail and demonstrated organizational skills. Ability to work in a fast-paced team environment, meet deadlines, and prioritize work. Bachelor's degree preferred in science. Associate degree with equivalent combination of education and work experience may be considered. 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience with basic laboratory techniques and basic laboratory safety practices. Prior experience in lot file review and/or management is preferred
