Quality Assurance Specialist

Quality Assurance Specialist

Position Summary

The Quality Assurance (QA) Specialist is responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with FDA, ISO, and GMP requirements. This role supports quality processes, internal audits, investigations, CAPA, change control, and continuous improvement while collaborating with cross-functional teams to uphold the highest quality standards.

Main Responsibilities

• Develop and implement Quality Assurance policies and QMS procedures;
• Gathering and trending of quality related data;
• Developing and implementing standards for inspection;
• Developing a workflow for tests/department inspection;
• Conduct quality inspections and internal audits, according to the quality plan, to ensure compliance with standards and regulations of FDA, ISO and GMP;
• Collaborate with cross-functional teams ...