Associate, QA Frontline
Location: Novato
Posted on: June 23, 2025
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Job Description:
Who We Are BioMarin is a global biotechnology company that
relentlessly pursues bold science to translate genetic discoveries
into new medicines that advance the future of human health. Since
our founding in 1997, we have applied our scientific expertise in
understanding the underlying causes of genetic conditions to create
transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology,
we develop medicines for patients with significant unmet medical
need. We enlist the best of the best – people with the right
technical expertise and a relentless drive to solve real problems –
and create an environment that empowers our teams to pursue bold,
innovative science. With this distinctive approach to drug
discovery, we’ve produced a diverse pipeline of commercial,
clinical and preclinical candidates that have well-understood
biology and provide an opportunity to be first-to-market or offer a
substantial benefit over existing therapeutic options. About
Technical Operations 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. DutiesAlternate Weds, Thursday -
Saturday 0600-1900 -Provide on-the-floor QA oversight and support
to manufacturing operations -Review executed batch records and
associated documents to ensure compliance with approved procedures
and cGMP expectations -Respond to quality-related incidents or
non-conformances on the floor and secure necessary documentation
for real-time investigations -Represent QA in support of deviations
including active participation in Root Cause Analysis (RCA)
-Provide cGMP and compliance guidance to Manufacturing and Novato
Technical Services (NTS) personnel-Provide QA support including
authoring, review, and approval of documents in Quality Management
Systems in accordance with BioMarin policies -Perform area
walkthroughs -Perform other duties and projects as assigned by
management Please note that while this role primarily involves
night and weekend shift hours, there may be occasions where the
need for flexibility is required, as shift hours can vary depending
on operational demands. Skills-Prior batch record execution or
review experience -Prior experience in investigation, change
control, other Quality Management Systems (QMS) -Working knowledge
of cGMPs -Excellent written and verbal communication and
interpersonal skills -Must display strong analytical and
problem-solving skills -Manufacturing and Manufacturing Sciences
experience preferred EducationB.S. in scientific discipline or
equivalent work experience. Note: This description is not intended
to be all-inclusive, or a limitation of the duties of the position.
It is intended to describe the general nature of the job that may
include other duties as assumed or assigned. Equal Opportunity
Employer/Veterans/Disabled An Equal Opportunity Employer. All
qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, or protected veteran status and
will not be discriminated against on the basis of disability.
Keywords: , Gilroy , Associate, QA Frontline, Science, Research & Development , Novato, California
