Job Description
The Quality Systems Specialist manages, coordinates, facilitates, and implements quality system processes to ensure compliance with cGMP, ICH, ISO, and internal quality standards. This role supports core Quality Management System activities including document control, training administration, audits, controlled documentation updates, and quality systems compliance.
Responsibilities

+ Maintain procedures and work instructions to ensure compliance with quality standards.

+ Track training assignments and compliance for all relevant personnel.

+ Support internal, supplier, and customer audits to ensure readiness and compliance.

+ Coordinate customer quality documentation requests effectively.

+ Participate actively in change controls, deviations, and CAPA-related activities.

+ Assist with quality metrics and trend reporting to support continuous improvement.

+ Collaborate cross-functionally with internal d...