LIMS/ELN Specialist — Master Data & Lab Ops Expert

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

Job summary

Cambrex Corp. in Charles City, IA, is seeking a LIMS Business Analyst to be the face of LabWare LIMS/ELN at the site. You will configure, support, and maintain Master Data, validate processes, and coordinate cross-site workflows in a regulated environment.

The role requires 3+ years in LIMS configuration, familiarity with cGMP/cGDP, and strong collaboration with development and QA teams. On-site position with a focus on data integrity and regulatory compliance.

Qualifications

• 3+ years of experience in configuration and administration of Laboratory Information Management Systems (LIMS).
• Experience supporting and integrating lab applications in a regulated industry.
• Knowledge of 21 CFR Part 11, data integrity best practices and computerized system regulatory compliance.
• Understanding of cGMP manufacturing.

Responsibilities

• Configure and maintain LIMS Master Data to support inventory management, QC/Analytical Research workflows, Raw Material/Intermediate/Finished API testing and release, ELN, cleaning validation and integration with other computerized site systems and instruments.
• Provide sound technical subject matter expertise on local and multi-site LIMS Master Data and workflows.
• Coordinate LIMS/ELN requirements gathering, fit-gapping, issue root cause identification, solution demos, validation testing, and documentation requirements for the site.
• Schedule business meetings and manage escalations to LIMS Development group, by applying impact assessments of the current issue list for the facility in order to support prioritization
• Assist with writing and execution of test scripts for validating LIMS/ELN workflows while maintaining cGDP principles
• Generate Master Data Verification Paperwork and manage the Master Data process from requirements induction to Production Promotion and Approval for use.
• Ability to interpret scientific documents, e.g. specifications and test methods, into LIMS coding to produce the required outcome in the system
• Primary contact for users to troubleshoot LIMS/ELN issues. Ability to evaluate and escalates as required.
• LIMS/ELN primary trainer for site personnel. Creates/updates user accounts following site procedures.
• Implement CAPAs to address LIMS/ELN related corrections and ensure CAPAs are completed within assigned time frame.
• Write/update LIMS related SOPs, Work Instructions, Protocols, and other system specific documentation.
• Understanding of pharmaceutical regulatory requirements cGDP and cGMP
• Able to communicate timelines, issues blocking progress, and status updates to management.

Skills

LIMS administration

Regulatory compliance knowledge

Data integrity

Education

Bachelor or Master in life science or IT

Tools

LabWare LIMS

Job description

Cambrex Corp. in Charles City, IA, is seeking a LIMS Business Analyst to be the face of LabWare LIMS/ELN at the site. You will configure, support, and maintain Master Data, validate processes, and coordinate cross-site workflows in a regulated environment.

The role requires 3+ years in LIMS configuration, familiarity with cGMP/cGDP, and strong collaboration with development and QA teams. On-site position with a focus on data integrity and regulatory compliance.