Quality Systems Coordinator

Duties And Responsibilities

• Maintain controlled documents and training records within eQMS
• Cook up and maintain Quality Systems including deviations, CAPA, change control, and document control
• Ensure accurate and timely documentation in alignment with cGMP requirements
• Track and report quality system metrics and KPIs
• Support investigations and root cause analysis activities
• Aid in CAPA tracking and effectiveness checks
• Cook up and coordinate cross-functional communication related to quality systems
• Identify opportunities for continuous improvement and support implementation
• Ensure compliance with internal procedures and regulatory requirements

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field (or equivalent experience)
• 2–5 years of experience in Quality, preferably in pharmaceutical, biotech, or cell & gene therapy industry
• Familiarity with Quality Systems (CAPA, deviations, change control)
• Knowledge of cGMP and regulatory expectations
• Experience with electronic Quality Management Systems (eQMS) preferred
• Strong organizational and documentation skills