Quality Assurance Officer II

Overview

In this role you will support the development, implementation, and maintenance of quality systems to ensure compliance and product integrity. You will enable batch reviews, drive investigations, and lead continuous improvement across GMP activities. You will collaborate with cross-functional teams, external vendors, and regulators to uphold quality standards and assist in audit readiness. This position offers exposure to advanced quality functions in a leading biotech/pharma environment with opportunities for ongoing development. You will help shape robust quality processes that enable reliable QP release and continuous improvement.

Pay / Benefits

• ongoing training and development

Responsibilities

• Develop, implement, and maintain Quality Assurance systems and activities
• Manage batch review and final quality review supporting QP release
• Improve GMP compliance, Change Controls, Deviations, and CAPA processes
• Lead root cause investigations and quality improvement initiatives
• Review and approve SOPs, validation documents, GMP records, and related quality documentation

Key requirements

• Degree or higher in a relevant field
• 5+ years’ experience in quality systems, technology, and supervision within a regulated biotech or pharmaceutical environment

• cross-functional collaboration
• stakeholder management
• effective communication
• GMP compliance
• Quality Assurance systems
• Change Controls

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