Senior Analyst, Quality Digital & LIMS

BioLife Plasma; Lexington (MA); Hybrid; USD 90,000 - 141,000; Full time

Job summary

Takeda is seeking a Quality Digital & Innovation, Senior Analyst (LIMS/MODA) to support administration, configuration, and continuous improvement of LabWare LIMS and MODA at the Massachusetts Biologics Operations site in Lexington, MA. You will work with QC, manufacturing, IT, and vendors to optimize workflows, master data, and interfaces, ensuring data integrity and regulatory compliance.

The role involves system validation activities, documentation, change management, and first-tier end-user

Qualifications

• Bachelor's degree in Engineering, Computer Science, Biology, Chemistry, or related field or equivalent experience.
• 2–4 years pharma/biopharma experience with laboratory systems or QC environments.
• Hands-on LabWare LIMS and MODA configuration/development experience; LabWare 8 preferred.
• Experience with SQL-based configuration for LabWare LIMS.
• Experience configuring interfaces between LIMS and QC instruments; Modbus or similar protocols desirable.
• Experience supporting computer systems validation, including URS, protocols, reports, and related docs.
• Knowledge of cGxP, GAMP 5, ISA-88, 21 CFR Part 11, data integrity and validated systems.

Responsibilities

• Maintain workflows, master data, and configurations in LabWare LIMS and MODA.
• Assist with system and instrument integrations and interface configurations.
• Perform master data updates and resolve master data issues.
• Provide first-tier application support to QC lab users.
• Create and maintain documentation for new functionality and updates.
• Support computer systems validation activities and change controls.
• Configure interfaces between lab systems and QC instruments (Modbus a plus).
• Collaborate with lab, QC, manufacturing, IT, vendors, and stakeholders to improve systems while maintaining validated state.

Skills

LabWare LIMS

MODA

SQL

LIMS interfaces

Modbus

GAMP 5

21 CFR Part 11

Data integrity

Regulatory compliance

Collaboration

Education

Bachelor's degree or equivalent

Tools

LabWare 8

MODA tools

Job description

Takeda is seeking a Quality Digital & Innovation, Senior Analyst (LIMS/MODA) to support administration, configuration, and continuous improvement of LabWare LIMS and MODA at the Massachusetts Biologics Operations site in Lexington, MA. You will work with QC, manufacturing, IT, and vendors to optimize workflows, master data, and interfaces, ensuring data integrity and regulatory compliance.

The role involves system validation activities, documentation, change management, and first-tier end-user