Quality Control Analyst

2 weeks ago


Novato, California, United States BioMarin Pharmaceutical Inc. Full time
Position Overview

The Quality Control Analyst plays a crucial role in ensuring the integrity and compliance of our operations at BioMarin Pharmaceutical Inc. This position involves a comprehensive approach to quality management within the manufacturing environment.

Key Responsibilities
  • Quality Oversight: Conduct direct observations of manufacturing processes to ensure strict adherence to Good Manufacturing Practices (GMP).
  • Documentation Review: Evaluate GMP documentation from both manufacturing and Quality Control (QC), which may encompass log books, batch records, and testing documentation.
  • Batch Record Management: Issue Production Batch Records to the manufacturing team and oversee the scanning and archiving of completed production batch records.
  • Compliance Assurance: Ensure that both manufacturing and QC operations comply with company policies, regulatory licenses, industry standards, and GMP regulations. Familiarity with United States and European regulatory requirements is advantageous.
  • Procedure Revision: Update and revise quality assurance-related procedures as necessary to maintain compliance and operational efficiency.

This role is essential in maintaining the high standards of quality that BioMarin Pharmaceutical Inc. is known for, contributing to the overall success and integrity of our pharmaceutical products.



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