Quality Assurance Specialist

Role: QA Oversight Specialist

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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 improvement initiatives

Profile xqbhyrx

• Experience working in a GMP-regulated pharmaceutical manufacturing environment
• Direct exposure to FDA inspections (very nice to have!)
• Strong understanding of deviations, CAPA, and quality systems
• Comfortable spending the majority of time on the production floor
• Proactive, detail-oriented, and confident working closely with operations