Quality Assurance Officer I
Replimune, Milton Park
The role
Overview
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.
What you will do
- Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness. Provide QA input and approvals to assist in and drive projects as needed.
- Perform batch review for GMP lots, in support of Qualified Person release including final Quality Review of associated quality records. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
- Drive improvement of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.