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Sr. Associate, Quality - Grave Shift

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
May 20, 2024

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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 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

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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