LIMS Specialist — Pharma Data Integrity & QC Systems

Cambrex - Charles City; Charles City (IA); On-site; USD 75,000 - 110,000; Full time

Job summary

Cambrex - Charles City is seeking a skilled LIMS Specialist to configure, maintain, and support the LIMS database for pharmaceutical operations. The role emphasizes data integrity, regulatory compliance, and CAPA-driven improvements across site systems.

You will configure data, validate LIMS subroutines, and train site personnel while serving as a primary contact for users and ensuring 21 CFR Part 11 compliance.

Qualifications

• Bachelor's or master's degree in life sciences or computer science/IT.
• 3+ years of experience configuring and administering LIMS.
• Experience with 21 CFR Part 11, data integrity and regulatory compliance.
• Experience integrating lab applications in a regulated environment.

Responsibilities

• Configure and maintain LIMS modules to support QC testing, inventory management, raw material testing/release, cleaning validation, and integration with site systems.
• Provide SME on local and multi-site LIMS projects.
• Configure static and master data within LIMS.
• Conduct validation of LIMS subroutines and code-based functionality.
• Assist with writing and execution of test scripts.
• Primary contact for users to troubleshoot LIMS issues.
• LIMS trainer for site personnel.
• Ensure system compliance with 21 CFR Part 11 and data integrity best practices.
• Implement CAPAs to address LIMS corrections and ensure timely completion.
• Write/update LIMS SOPs, Work Instructions, Protocols, and related documentation.

Skills

LIMS configuration

LIMS administration

Regulatory compliance

Data integrity

CAPA implementation

Education

Bachelor's or Master's degree in life science or computer science/IT

Tools

LIMS

Job description

Cambrex - Charles City is seeking a skilled LIMS Specialist to configure, maintain, and support the LIMS database for pharmaceutical operations. The role emphasizes data integrity, regulatory compliance, and CAPA-driven improvements across site systems.

You will configure data, validate LIMS subroutines, and train site personnel while serving as a primary contact for users and ensuring 21 CFR Part 11 compliance.