Job Title: QC Laboratory Master Data Specialist
Introduction: We are seeking a skilled QC Laboratory Master Data Specialist to play a pivotal role in supporting the configuration, maintenance, and standardization of laboratory master data across our global pharmaceutical manufacturing QC laboratories. This position is critical to ensuring the accuracy, consistency, and compliance of laboratory data systems that underpin quality control processes. The specialist will work closely with QC, Digital, and Quality teams to maintain and enhance our laboratory information management systems, including LabWare LIMS, Empower CDS, and the transitioning Veeva LIMS platform. This role focuses on hands‑on master data configuration and ongoing operational support rather than system implementation or data migration.
Roles and Responsibilities:
- Configure, maintain, and troubleshoot laboratory master data within LabWare LIMS, Empower CDS, and other QC laboratory systems.
- Build and update laboratory specifications, analytical methods, calculations, product variables, reagents, testing parameters, and workflows to support QC operations.
- Gather and analyze requirements directly from QC laboratory end users, translating scientific and operational needs into precise master data configurations.
- Understand and utilize LIMS tables, relational database concepts, and the interaction of laboratory master data objects to ensure data integrity and system functionality.
- Provide ongoing business‑as‑usual (BAU) support, including maintenance, issue resolution, and configuration changes across multiple laboratory sites.
- Maintain and enforce laboratory master data standards, including field definitions, usage guidelines, and standardized configurations to support global consistency.
- Manage shared system objects such as units, conditions, stored queries, folders, and reports to optimize laboratory workflows.
- Collaborate with cross‑functional teams (QC, Digital, Quality) to ensure configurations meet operational and regulatory compliance requirements, including GMP/GxP standards.
- Support testing, validation, change control, and documentation processes associated with master data updates and system changes.
- Develop training materials and deliver training or guidance to laboratory end users to ensure effective system utilization and data accuracy.
- Support the expansion and deployment of Empower CDS and Veeva LIMS, ensuring seamless master data integration and configuration.
Qualifications:
- Proven hands‑on experience working in pharmaceutical QC laboratories or directly supporting pharmaceutical QC laboratory operations.
- Demonstrated experience configuring, creating, or maintaining laboratory master data within a LIMS or similar laboratory applications.
- Strong understanding of laboratory calculations and the impact of changes to product variables, specifications, or methods on these calculations.
- Solid knowledge of LIMS master data tables and relational database concepts.
- Experience gathering laboratory end‑user requirements and translating them into system configurations or master data builds.
- Skilled in supporting ongoing BAU laboratory master data maintenance, troubleshooting, and operational support.
- Excellent communication skills with the ability to clearly engage with laboratory users, understand scientific requirements, and explain technical solutions effectively.
- Familiarity with GMP/GxP requirements and experience working with validated laboratory systems.
Preferred Qualifications:
- Hands‑on experience with LabWare LIMS administration or master data configuration.
- Experience with Empower CDS master data management.
- Expertise in maintaining global or multi‑site laboratory standards and shared system objects.
- Proven ability to develop training materials and conduct training sessions for laboratory end users.
- Experience building master data configurations for new laboratory deployments, especially transitioning from paper‑based processes to electronic LIMS.
- Knowledge of Veeva LIMS or other SaaS laboratory systems.
- Familiarity with laboratory instrument integrations, middleware, SQL, Excel calculations, or Python scripting.
Tools and Technologies:
- LabWare LIMS
- Empower CDS
- Laboratory Information Management Systems (LIMS)