The Sr. Specialist, QA Operations provides Quality Assurance support for GMP pharmaceutical manufacturing, reviewing quality records from Contract Manufacturing Organizations for CGMP compliance, conducting deviation investigations, and supporting new product introduction processes.… The role requires independently managing quality disposition of GMP products, participating in change control and audit activities, and interfacing with internal and external stakeholders to resolve quality issues. A BS/BA in Life Sciences or Engineering with 4+ years of pharmaceutical/biotech QA experience (or Master's with 2+ years) is required, along with hands-on knowledge of batch records, deviation reports, FDA/EU regulations, ICH Guidelines, and electronic quality management systems.