Quality Assurance Specialist
1 week ago
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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