Senior Quality Associate

1 month ago


Novato, California, United States BioMarin Full time

Join BioMarin's Technical Operations team and contribute to the creation of life-changing drugs for patients worldwide. As a Senior Associate, Quality, you will play a critical role in ensuring the quality and compliance of our manufacturing processes and products.

Responsibilities:
  • Provide on-site quality oversight and support to manufacturing operations, ensuring adherence to cGMP expectations and regulatory standards.
  • Review and verify executed batch records and associated documentation to ensure accuracy and compliance.
  • Respond to quality-related incidents and non-conformances, securing necessary documentation for real-time investigations and root cause analysis.
  • Represent QA in support of deviations, actively participating in root cause analysis and providing cGMP and compliance guidance to manufacturing personnel.
  • Provide quality support, including writing, reviewing, and approving documents in Quality Management Systems, in accordance with BioMarin policies.
  • Perform area walkthroughs and other duties as assigned by management.
Requirements:
  • Bachelor's degree in a scientific discipline or related field and 6-8 years of experience in a biologics manufacturing environment.
  • Prior batch record review experience is required.
  • Prior experience in investigation, change control, and other Quality Management Systems is preferred.
  • Working knowledge of cGMPs and excellent written and verbal communication skills are essential.
  • Strong analytical and problem-solving skills are required.
  • Manufacturing and MSAT experience is a plus.
What We Offer:
  • A competitive salary range of $93,200 to $139,800 per year, depending on location and experience.
  • A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package.
  • A comprehensive benefits package, including medical, financial, and other benefits.

BioMarin is an Equal Opportunity Employer and welcomes applications from diverse candidates. 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.



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