Quality Control Specialist III

Job Description

About the role:

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.

This role is ideal for someone passionate about digital transformation in the lab environment, with strong hands‑on LIMS experience and the ability to partner cross‑functionally to elevate QC capabilities.

• 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 setup, 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 wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make‑up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Must be able to lift, push, pull and carry up to 15 lbs.
• In general,…