LIMS Specialist
Job in
Thousand Oaks, Ventura County, California, 91362, USA
Listed on 2026-10-30
Listing for:
Katalyst-Healthcares-
Full Time
position Listed on 2026-10-30
Job specializations:
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
- Workstream Leadership & Scope Definition
- Support a dedicated workstream supporting implementation of raw material and commercial product processes within Lab Ware LIMS 8.
- Define and manage Lab Ware build across:
- Raw materials and commercial product master data
- Test workflows
- Laboratory equipment and interfaces
- Lab Ware LIMS Configuration to Configure raw materials, commercial products including stability, and laboratory equipment in Lab Ware LIMS using standardized, compliant design patterns. Ensure Lab Ware configuration aligns with Approved test methodologies, Product specifications and Sampling plans
- Apply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
- Requirements Traceability & Validation Support
- Translate regulatory, quality, and operational requirements into standardized Lab Ware LIMS designs.
- Support validation activities by providing clear documentation and traceability for configured Lab Ware objects following Client internal procedures.
- Instrument & System Integration to Configure and support instrument interfaces between Lab Ware 8 and a variety of laboratory systems.
- May develop or support parsing scripts, where required and permitted by Takeda standards and governance.
- Support connectivity and data flow between Lab Ware and other GMP systems, such as LabX
- Operational Readiness & Execution to Support stable execution of raw material and equipment workflows in live operations.
- Troubleshoot configuration and integration issues impacting laboratory execution.
- Partner with site teams to ensure Lab Ware configurations are fit for intended use and operationally sustainable.
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