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.

QC Stability Coordinator 

ROLE 

High-performing, team-based  organization,  where  colleagues  are  flexible,  multi-skilled  and 

empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as organizational skills. 

The stability and sample coordinator report directly to the QC Manager and is responsible for 

coordinating the movement and storage of product related samples, as well as the coordination of stability testing in QC 

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 individuals 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. 

KEY RESPONSIBILITIES  

• Contribute to selection of intermediate and product lots produced at BioMarin for stability
• studies.
• Coordinate and contribute to the scheduling of stability testing in QC. Trend stability data and report on same
• Prepare stability related protocols, summaries, and reports - often for direct submission to pharmaceutical regulatory agencies.
• Coordinate movement and storage of samples for testing within QC, within Biomarin and to and from contract laboratories.
• Manage the retention and reserve sample program.
• Act as technical resource (SME) and train other analysts in areas of expertise.
• Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents.
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
• Interact indirectly with regulatory agency inspections during audits
• Other duties as assigned

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.