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The stability and sample coordinator reports 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.
Job Responsibility:
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 inspectors during audits
Other duties as assigned
Requirements:
Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required
Minimum 3-5 years relevant industry experience
Good project management skills
Experience in presenting to senior management
Lead from front attitude
Knowledge of regulatory guidelines and directives
Data orientated with good risk management understanding