Skip Navigation

Quality Assurance Specialist (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


This position is responsible for performing BioMarin Quality Assurance (QA) review of Contract Manfuacturing Organization (CMO) manufacturing batch records and associated documentation.   This includes receipt, QA review and archival of executed manufacturing batch records and associated documentation such as QC test forms, and updating QA databases. QA review of manufacturing batch records includes verifying conformance to cGMPs, SOPs and batch record process limits



The ideal candidate will have strong organization and communication skills.



The individual is expected to communicate well with CMO/Packaging Ops, Quality Assurance, Quality Control, Regulatory Affairs, and Supply Chain both at BioMarin and CMOs.



RESPONSIBILITIES



    • Perform BioMarin QA review of BioMarin Manufacturing executed batch records and associated documentation for compliance with cGMPs, BioMarin SOPs, and other BioMarin polices and procedures.

    • Ensure adherence to company policies/procedures, regulatory licenses, applicable Quality and Technical agreements, industry standards, and GMP regulations.

    • Receive, control, scan and archive CMO executed batch records.

    • Prepare lot history folders for Drug Product (DP) lots.

    • Update QA CMO datases/Oracle EBS

    • Obtain data for complaint investigation, etc.

    • Other QA CMO duties as assigned.



Scope



The scope of this position is limited to performing department tasks in accordance with supervisor’s instructions

Skills



EXPERIENCE



    • 1-5 years of directly related experience in a GMP Quality or Manufacturing environment.

    • Working knowledge of process and desktop computers. Proven comprehension of technical information and regulatory expectations.




Education



    • BA or BS in a technical discipline (physical or biological sciences preferred).


Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.


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

View

Our Benefits

View

Hiring Insights

View

Living and Working in San Rafael

View
We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
Return to the top of the page