Quality Assurance Specialist

Job Title: Quality Assurance SpecialistJob Description
The Quality Systems Quality Assurance Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment. This role focuses on executing and maintaining key quality processes, including GMP training programs, validation and qualification document review, investigations, deviations, change controls, and corrective and preventive actions (CAPAs). The specialist spends a majority of the day overseeing the CAPA system, tracking progress, driving timely closure, managing extensions when needed, and supporting deviation management. The position collaborates cross‑functionally to ensure compliance with quality system procedures, supports continuous improvement initiatives, participates in internal and external audits, manages training documentation, and oversees activities such as annual product review (APR) preparation and change control governance to ensure regulatory compliance and product qualit...