Quality Systems Specialist

Job Title: Quality Systems Specialist
Job Description
The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, with a primary focus on executing and maintaining quality processes such as GMP training programs, validation and qualification document review, investigations, deviations, change controls, and CAPAs. The role centers on overseeing the CAPA system, including tracking actions, driving timely closure, managing extensions, and supporting deviation management. This position collaborates cross‑functionally to ensure compliance with quality system procedures, supports continuous improvement initiatives, contributes to internal and external audits, manages training documentation, and oversees activities such as annual product review preparation and change control governance to ensure regulatory compliance and product quality.
Responsibilities

+ Oversee the CAPA system on a daily basis, including tra...