QC Analyst II

As a Quality Control Analyst II, you will help maintain reliable laboratory operations and support the quality of manufacturing samples and products. You will independently manage assigned analytical work, applying your understanding of assay principles, instrument performance, laboratory controls, and quality systems to produce accurate, well-documented results. You will be part of the Analytical Quality Control team in Thousand Oaks, working with analysts, quality partners, technical support, and laboratory leadership.

Your sound scientific judgment will help identify unexpected results, address routine and moderately complex issues, and support evidence-based investigations. You will also help less experienced analysts build their skills in established methods and documentation. By balancing testing priorities and escalating complex decisions appropriately, your work will contribute to dependable laboratory outcomes and team goals.

• Manage assigned analytical testing from sample and method readiness through execution, calculations, documentation, and timely handoff for review.
• Perform laboratory analyses of raw materials, in-process and final products, environmental-monitoring samples, and other manufacturing samples using approved methods and qualified equipment.
• Assess controls, instruments, and results during testing to identify potential execution or equipment issues and results that may need quality-system evaluation.
• Troubleshoot routine and moderately complex issues with methods and instruments, document actions and impacts, and
  ** escalate issues beyond your authority.
• Maintain and review testing records for accuracy, traceability, calculations, method adherence, and compliance, and complete authorized data reviews and system transactions.
• Support quality investigations and laboratory improvements by reporting atypical results promptly, preserving relevant records and samples, and collaborating on evidence-based assessments and practical improvements.
• Coordinate laboratory readiness and coach analysts by addressing equipment, supply, and scheduling constraints and supporting less experienced colleagues on established methods and documentation.

• High school diploma or equivalent.
• At least three years of relevant laboratory or quality-control experience.
• Practical understanding of analytical methods, critical controls, expected assay behavior, and how sample handling or preparation can affect results.
• Ability to independently perform and assess routine and moderately complex laboratory analyses and recognize unexpected control, instrument, or result patterns.
• Working knowledge of applicable FDA and GMP requirements, Good Documentation Practices, data integrity, standard operating procedures, and laboratory quality systems.
• Ability to review testing records, conduct authorized data review and laboratory data system transactions, and support investigations within assigned authority.
• Ability to plan and prioritize concurrent testing, communicate technical issues clearly, and collaborate with analysts, quality partners, technical support, and laboratory leadership.
• Proficiency with laboratory data systems and Microsoft Office applications for documenting, reviewing, and communicating assigned work.

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud…