Quality Assurance Specialist

Role: QA Oversight Specialist Hlx are partnered with a fast-growing biologics CDMO who are growing their quality capabilities. We are looking for a QA Oversight Specialist, reporting to the Senior Quality Manager. This is a highly visible, hands-on role focused on real-time GMP oversight on the production floor, ensuring product quality and inspection readiness. Focus of Role: To supervise and coordinate Quality Assurance activities within assigned processes, ensuring full compliance with GMP requirements and internal Quality Systems. Key Responsibilities Provide hands-on QA oversight on the production floor to ensure GMP compliance Lead and support deviation management, investigations, and CAPA execution Review and approve batch documentation and critical process parameters Monitor quality KPIs and verify effectiveness of implemented CAPAs Support and participate in internal and external audits, including FDA inspections Ensure GMP training compliance and contribute to continuous impr...