Quality Digital & Innovation Analyst (LIMS/MODA)

Takeda Pharmaceutical Company Limited

Lexington (MA)

On-site

USD 90,000 - 141,000

Full time

14 days+

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Job summary

Takeda Pharmaceutical Company Limited is seeking a Quality Digital & Innovation Senior Analyst (LIMS/MODA) to administer and enhance LabWare LIMS and MODA at the MA Biologics Operations site in Lexington. You will support system configuration, integrations with QC instruments, and change management while ensuring compliance and data integrity.

You will work with QC, manufacturing, IT, and vendors to drive continuous improvement, participate in validation activities, and provide first-tier

Qualifications

Bachelor's degree in Engineering, Computer Science, Business, Chemistry, Biology, or related field.
2–4 years of pharmaceutical or biopharmaceutical experience, preferably supporting laboratory systems.
Hands-on configuration and development experience with LabWare LIMS and MODA; LabWare 8 experience desirable.
Experience with SQL-based configuration capabilities, particularly in LabWare LIMS.
Experience developing or configuring interfaces between LIMS and QC laboratory instruments; Modbus or similar protocols desirable.
Experience supporting computer systems validation, including validation plans, URS, protocols, reports, and related documentation.
Working knowledge of cGxP, GAMP 5, ISA-88, 21 CFR Part 11, data integrity principles, and validated laboratory systems.

Responsibilities

Maintain and update LabWare LIMS and MODA workflows, master data, and configurations to support routine operations and continuous improvement.
Assist with system and instrument integrations, configuring interfaces between LIMS and QC instruments with stakeholders.
Perform master data updates and resolve master data issues while supporting routine system administration tasks.
Provide first-tier application support to QC laboratory end users, troubleshooting routine issues.
Create and maintain method verification scripts and technical documentation for new functionality and updates.
Support computer systems validation activities, including plans, URS, protocols, and reports.
Configure and maintain interfaces between lab systems and QC instruments; experience with Modbus or similar protocols.
Assist with change controls, system requests, and IT ticketing (ServiceNow) and coordinate approvals.
Collaborate with lab, QC, manufacturing, IT, vendors, and stakeholders to identify system/process improvements while maintaining data integrity.
Support regulatory inspections as a technical SME for laboratory systems and processes.