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Quality Control Data Management Analyst (TEMPORARY)

Location Novato, California Workstyle Onsite Only
Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

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 Quality Control Data Management Analyst is responsible for the management of the GMP documentation and data in support of:

  • Test and release of Bulk Drug Substance and Drug Product
  • Test of stability samples
  • Testing and support for critical reagents and reference standards
  • CMO testing
  • Product Complaints

Key functions of the role include:

  • Generation of Certificates of Analysis
  • Compilation of test summaries
  • Filing of paper test records
  • Maintaining an organized Quality Control document room
  • Archival of data and maintenance of systems to allow for identification and retrieval of archived data
  • Compilation of stability data
  • Provide LIMS reports for completed data
  • Troubleshoot errors in data
  • Returning data packets to obtain corrections
  • Working with QA partners to obtain CTO data
  • Documentation generation to support QA partner needs
  • Provide records for other BioMarin sites.
  • Maintain a database of offsite data storage and send data offsite as needed

Skills


The position requires well developed organization skills with exact attention to details.  Good written and verbal communication skills are essential.  Computer literacy and experience with Microsoft Word and Excel are required.  Experience with Quality Control and/or current Good Manufacturing Practices is a plus.

Education


Associate's degree with 0-2 years of relevant experience or High School Diploma/GED with 2+ years of relevant experience.



PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, 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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