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
Ensu...