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External Quality Associate I

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
May 30, 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.

Hybrid - 2 days onsite (Tuesday anchor day and addtional to be worked out with manager)  We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others. The Quality Associate 1 reports to the Quality Manager and is responsible for supporting Quality Systems related to operations, product specification change controls and batch release processes.  This position requires interaction with multiple levels in Quality, Regulatory Affairs, Manufacturing, Supply Chain, Materials Management, and Contract Manufacturing 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 individuals 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.

 

SkillsKEY RESPONSIBILITIES 
  • Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in BioMarin's controlled document management system (Veeva).
  • Initiate and set-up change control workflows for product specification revisions in Veeva and BioMarin's quality management system.
  • Coordinate Veeva change control workflows for review and approval of product specification revisions.
  • Monitor and ensure document implementation timelines.
  • Monitor backlog in associated trackers.
  • Generate custom Certificates of Analysis to support lot release, new market applications, annual product reviews, and/or market renewals.
  • Ensure all individual training and group-specific guidelines are kept current.
  • Provide assistance with training new staff.
EXPERIENCE 
  • Minimum 3-5 years of experience in a Quality, Compliance, and/or Regulatory setting.
  • Strong attention to detail, organization and communication skills.
  • Ability to maintain organization of a large volume of data in a systematic manner
  • Proficiency with computer systems (Microsoft Office Suite).
  • Proficiency with eQMS (Veeva), LIMS, Oracle EBS, eCDMS (Veeva) and Office365 preferred.
Education
  • Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.
  • Advanced degree preferred.



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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