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QA Associate (TEMPORARY)

Location Novato, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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. Come join our team and make a meaningful impact on patients’ lives. 

Duties



    • Conduct laboratory, environmental monitoring (alert, action) and deviation investigations in the QC and QA Operations areas. 

    • Facilitate investigation related meetings, including root cause analysis.

    • Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented. These reports may be related to manufacturing, facilities, QA or QC related events.

    • Monitor trackwise record workflows and report metrics to area manager.



Skills



    • Minimum 3 years’ relevant experience in a cGMP regulated QC laboratory, with exhibited knowledge and proficiency in investigations (investigator and QA approver roles).

    • Experience and ability to work cross functionally as needed.

    • Experience in supporting Quality Operations is highly desirable.

    • Strong ability to facilitate investigational meetings autonomously.

    • Ability to track work and present metrics to management as needed.

Education


Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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