Quality Control Specialist III

Job Description

Quality Control Specialist III – Takeda, Los Angeles, CA

Takeda’s Los Angeles Quality Control team is seeking a QC Specialist III who will serve as the primary LIMS subject matter expert (SME) for the site. In this role, you will design, configure and optimize LIMS and related digital solutions—driving compliant, paperless and highly efficient QC laboratory operations. You will lead end‑to‑end implementation of system changes and support complex QC projects, leveraging deep Lab Ware expertise, data analytics and digital tools to enhance data integrity and operational excellence.

• Lead the transformation of QC laboratory operations through design, configuration and enhancement of LIMS and related QC informatics platforms.
• Apply AGILE methodologies to plan, prioritize and manage LIMS system changes and releases.
• Serve as the primary system owner for QC Lab Ware LIMS, focusing on configuration, lifecycle management, data integrity and alignment to business processes.
• Maintain deep expertise in Lab Ware set‑up, including master data structures, workflows, templates, calculations and interface design.
• Execute full lifecycle implementation of Lab Ware changes—requirements, design, configuration, testing, validation and deployment.
• Evaluate and implement LIMS functionalities and integrations that streamline QC workflows and reduce manual effort.
• Act as SME for QC systems such as Lab Ware, MODA and associated digital interfaces to support system design decisions and user story development.
• Customize and optimize LIMS workflows and user interfaces to enable accurate data capture and standardized testing.
• Maximize use of LIMS and connected tools (e.g., EM, LES, equipment interfaces) to enhance performance and data integrity.
• Support data science and analytics projects through high‑quality, structured data extraction from LIMS and QC systems.
• Assist with creation of analytical and reporting tools to monitor QC trends, robustness, OOS/OOT rates and turnaround time.
• Collaborate with QC, IT, Digital, Validation, Manufacturing and Quality Systems on LIMS enhancements, integrations and validation strategies.
• Participate in global and local informatics forums to support harmonization of QC processes and data structures.

• Bachelor’s degree in science, engineering or another technical field.
• 3+ years of related experience.
• Strong understanding of QC operations, GxP and data integrity principles.
• Demonstrated hands‑on proficiency in Lab Ware LIMS, including configuration, master data management, workflow design and system optimization.
• Experience supporting change control, validation and LIMS lifecycle management.
• Ability to design and implement paperless digital solutions within QC environments.
• Strong analytical background, with experience using QC/LIMS data to support decision‑making.
• Ability to manage multiple system changes and projects while maintaining compliance and quality standards.
• Strong communication, collaboration and stakeholder‑influencing skills.
• Experience working in AGILE or hybrid project environments.

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science or a related field.
• Advanced Lab Ware LIMS experience and integration knowledge.
• Experience with digital QC tools such as ELN, CDS or MODA.

• Work in a controlled environment requiring special gowning and personal protective equipment.
• Remove make‑up, jewelry, contact lenses, nail polish or artificial fingernails while in the manufacturing environment.
• Work in cold, wet or chemically exposed environments.
• Work multiple shifts, including weekends, or be asked to work supplemental hours as needed.
• Must be able to lift, push, pull and carry up to 15 lbs.
• Position requires a combination of sedentary work and walking to observe facility conditions.
• Work in controlled environments requiring special gowning; follow gowning requirements and wear protective clothing.
• Some clean room and cool/hot storage conditions apply.

Takeda is transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. As a…