QA Associate

Responsibilities

• Provide Quality oversight and direction for the start-up, technical transfer, and operation of Sterile Drug Product Filling.
• Write, review, and approve GMP documentation including SOPs, Work Instructions, Master Batch Records, and Specifications.
• Provide Quality input to Change Controls, Protocols, and Reports to ensure robust implementation.
• Manage Deviations and associated CAPAs, ensuring root cause analysis is thorough and implementation plans are achievable.
• Support Lot Release processes for components, raw materials, and drug products in compliance with GMP.
• Lead Area GMP Certification activities and support regulatory inspection readiness.
• Proactively identify compliance risks and lead root cause analysis for complex issues.

Requirements

• Degree or 3rd level qualification in Science or Quality.
• 5+ years of experience in a Quality function within the pharmaceutical or biotechnology industry.
• Demonstrated experience in Sterile Drug Product Filling and facility start-up.
• Strong knowledge of FDA and EMEA regulations and quality standards.
• Proven experience in managing Root Cause Analysis, Non-Conformance, and Deviation investigations.
• Proficiency in MS Office (Excel, Word, PowerPoint).
• Excellent written and verbal communication skills with strong organizational abilities.

Preferred Qualifications

• QP Qualification.
• Experience with MES (Manufacturing Execution Systems).
• Knowledge of Validation processes.
• Experience with Lean or Continuous Improvement practices.

About the Company

BioMarin is a leading rare disease biotechnology company focused on developing medicines that make a profound impact on people’s lives. Our global teams deliver revolutionary therapies for genetically defined conditions, supported by world-class manufacturing capabilities and a deep commitment to scientific excellence.