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Associate 2, Quality (Grave Shift)

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Oct 17, 2024
View more categoriesView less categories
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

Who We Are

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.

Senior Associate, Quality – On-Site Grave and Weekend Shift  Responsibilities: -Provide on-the-floor QA oversight and support to manufacturing operations -Review executed batch records and associated document 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 Manufacturing Sciences and Technology (MSAT) personnel -Provide QA support including write, review, and approve documents in Quality Management Systems in accordance with BioMarin policies -Perform area walkthroughs -Perform other duties and projects as assigned by management  Experience and Other Qualifications: -BS/BA in a scientific discipline or related field and 6-8 years experience in a biologics manufacturing environment -Prior batch record review experience is required -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 MSAT experience preferred  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.   Shift Details: Alternate Wed, Thurs-Sat 1800-0700 **We do provide Shift Differential pay for any off-hour shifts including Swing and Grave** No international travelling required. 

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.

Company

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 have developed eight important medicines for patients with significant unmet medical need. Our approved therapies treat achondroplasia, severe hemophilia A and several rare inherited and lysosomal storage diseases.

As we have looked to expand our impact, our approach to cutting-edge science has remained the same. 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. Our work is deeply rooted in genetic insights, meaning we target the underlying genetic changes or proximal molecular mechanisms of disease.

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.

Company info
Website
Location
San Rafael and Novato
California
United States

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