(CW) QA Associate (TEMPORARY)

Role Summary

This position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities. The QA Associate will have proven capability in promoting Quality across cross-functional teams, to deliver high quality product, ensuring continuous process improvement. The QA Associate will model the BioMarin Leadership behaviors and understand the principles to drive a culture of continuous improvement building a High-Performance Organization.

Responsibilities

• Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.
• Provide Quality input to Deviations ensuring scope of record is clear and investigations are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
• Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply, Distribution, Maintenance, Metrology, and Quality Control employees to immediately address issues and questions in real time to help ensure timelines are achieved to meet customer requirements. Minimizing impact to Lot Release operations on site.
• Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.