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Quality Document Control Specialist

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Apr 10, 2024

View more

Discipline
Clinical, Clinical Medicine, Quality
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.

Onsite with Hybrid option after training The QA Documentation Control Specialist II is responsible for the maintenance of the cGMP controlled documentation system and for providing the various BioMarin departments the documentation that is necessary to perform cGxP activities.  Other responsibilities include auditing existing documentation, reporting document trends to management, and managing electronic document systems.
  • Process requests for document changes utilizing the EDMS
  • Process document Special Handling requests
  • Provide department metrics to management
  • Participate in documentation audits
  • Process logbook requests and perform routine audits
  • Process laboratory notebook requests
  • Responsible for maintaining Archive Room: filing, assisting customers
  • Identifies improvements with group-level impact
  • Manages assigned work and takes on additional responsibilities
  • Involved with other projects as required
Skills
  • Preferred experience in auditing documentation
  • Proficiency in MS Word & MS Excel.  Livelink and MS Access a plus
  • Ability to communicate clearly and effectively through verbal and type-written correspondence 
  • Legible penmanshipOrganizational skills to coordinate multi-discipline projects
  • Experience in participation in regulatory inspections a plus
  • Understanding and familiarity with FDA and European regulatory requirements, guidelines
Education
  • BA or BS in a related discipline
  • Equivalent experience may be considered.



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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