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The Quality Assurance Specialist II is responsible for supporting Quality Systems, including investigation/deviation management, CAPA tracking, Effectiveness Verification, change control, internal and external audits. This position will facilitate the compiling, trending (as required), and reporting key quality metrics for management, and other quality system functions, as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.