LIMS Specialist - QC Data Integrity & Validation

Cambrex Corp.; Charles City (IA); On-site; USD 70,000 - 90,000; Full time

Job summary

Cambrex is seeking a LIMS Specialist to configure, support and maintain the LIMS database for pharmaceutical commercial operations. You will translate business needs into system setups and ensure data accuracy across QC, inventory and materials testing.

You will collaborate with cross-site teams, validate subroutines, write SOPs, and train site personnel while upholding 21 CFR Part 11 compliance and data integrity standards in a fast-paced GMP environment.

Qualifications

• 3+ years of experience with LIMS configuration and administration.
• Experience with regulated lab applications.
• Familiarity with 21 CFR Part 11 and data integrity practices.

Responsibilities

• Configure and maintain LIMS modules to support QC testing, inventory management, raw material testing/release, cleaning validation and integration with other site systems.
• Provide sound technical subject matter expertise on local and multi-site LIMS projects.
• Configure static and master data within LIMS.
• Conduct validation of LIMS subroutines, analyses and other 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 is compliant with 21 CFR Part 11 and data integrity best practices for pharmaceutical environments.
• Implement CAPAs to address LIMS related corrections and ensure CAPAs are completed within assigned time frame.
• Write/update LIMS related SOPs, Work Instructions, Protocols, and other system specific documentation.

Skills

cGMP knowledge

Education

Bachelor's or Master's in life science or CS/IT

Job description

Cambrex is seeking a LIMS Specialist to configure, support and maintain the LIMS database for pharmaceutical commercial operations. You will translate business needs into system setups and ensure data accuracy across QC, inventory and materials testing.

You will collaborate with cross-site teams, validate subroutines, write SOPs, and train site personnel while upholding 21 CFR Part 11 compliance and data integrity standards in a fast-paced GMP environment.