QA Associate

at  Biomarin

Who We Are
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

• Provide Quality input and guidance to ensure Lot Release (Final Packed Finished Product) of high-quality products in compliance with current Good Manufacturing Practices (GMPs).
• Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs.
• Support for the Secondary Packaging Operations team including performance of AQL inspections during routine operations.
• Provide Quality direction and oversight of the development and continuous improvement of new and existing processes / systems to meet customer needs.
• 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 Change Control/Deviations ensuring scope of record is clear and implementation activities 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 timeline are achieved to meet customer requirements. Minimising impact to Lot Release operations on site.
• Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
• Review and release inputs for use in manufacturing as required.
• Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies.
• Assignments may range from routine to more complex/non-routine projects/assignments, where analysis of situation or data requires a review of identifiable factors within the Lot Release operations area.
• Coordinates, plans, implements projects within specified objectives
• Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
• Reviews executed packaging batch records and associated documentation.
• Participates in customer complaint investigations if required.
• Provides training and advice to staff in order for them to perform their desired functions.
• Participation in and leading internal inspections in the Lot Release area of operations.
• Prepare reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes.