Quality Assurance Specialist

1 week ago


Novato, California, United States BioMarin Full time

BioMarin is a leading biotechnology company focused on developing innovative therapies for rare genetic diseases. The Technical Operations group plays a critical role in creating and scaling production of drugs for clinical trials and commercial use.

Key Responsibilities:

  • Create and revise product specification documents in our controlled document management system to ensure accuracy and compliance.
  • Initiate and set up change control workflows for product specification revisions to maintain regulatory compliance.
  • Coordinate review and approval of product specification revisions to ensure timely implementation.
  • Monitor document implementation timelines and backlog to optimize productivity.
  • Generate Certificates of Analysis and ensure training guidelines are current to maintain quality standards.

Requirements:

  • Minimum 3-5 years of experience in Quality, Compliance, or Regulatory setting.
  • Strong attention to detail, organization, and communication skills to effectively collaborate with cross-functional teams.
  • Proficiency with computer systems and eQMS preferred to streamline processes.

Education:

  • Bachelor's degree in a technical discipline required, advanced degree preferred to demonstrate expertise.

BioMarin is an Equal Opportunity Employer committed to diversity and inclusion. We offer a competitive compensation and benefits package, including medical and financial options, to support the well-being of our employees.



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