Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in ****, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.
We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science.
With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations 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.
his position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities.
The Quality Packaging Specialist will have proven capability in promoting Quality across cross-functional teams, to deliver high quality product, ensuring continuous process improvement.
The Quality Packaging Specialist will model the BioMarin Leadership behaviors and understand the principles to drive a culture of continuous improvement building a High Performance Organisation.
QA Specialist Responsibilities: Provide Quality input and guidance to ensure packaging of high quality products in compliance with current Good Manufacturing Practices (GMPs).
Provide Quality direction and oversight of the development of new and existing processes in the packaging area 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 within the packaging area of operations.
Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely.
Review and approval of NCs 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