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Sr. Global QA Product Complaint 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.


The Global QA Product Complaint Associate will be resonsible for the receipt and initiation of Product Complaints in Trackwise, including high level assessments of Product Complaints.   This position will also support other Product Complaint related activities such as intake reconcilliation, summary reports and trending. 


The position will be responsible for Receipt and evaluation of Product Complaints and inititaion of the report in Trackwise

Follow up with multiple groups to ensure timeliness of closure

Perform reconcilliation of Product Complaints and Adverse Events

Create metrics and trend data 

Other duties as assigned


2-8 years of direclty related Product complaint experience in a GMP Quality or Manufacturing environment.

Experience and proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point

Exellent verbal and written communication skills

Product Comlaint or Deviation Investigation Experience prefered

Experience with TrackWise preferred


BA or BS in a technical discipline (physical or biological sciences preferred but not required). Equivalent experience may be considered.

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.

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