The Senior Quality Specialist, Laboratory Investigations & Data Integrity is an experienced Quality Control individual contributor responsible for leading and completing laboratory investigations, OOS/OOT assessments, CAPA development, and comprehensive review of analytical data in a cGMP pharmaceutical laboratory. · Laboratory Systems and Controls: Partner with QC management, QA, IT, validation, metrology, and system owners to evaluate laboratory computerized systems, user access, segregation of duties, time synchronization, method and processing controls, data paths, interfaces, backup and archival arrangements, and system limitations.