LIMS Business Analyst

Cambrex; 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

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

• We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

Job Overview

The LIMS Business Analyst will be the face of the LabWare Laboratory Information Management System (LIMS)Electronic Laboratory Notebook (ELN) at the Charles City Facility, by acting as the first level support contact for operational support and Master Data builds. They will configure, support, maintain and administer the LabWare LIMSElectronic Laboratory Notebook (ELN) Master Data at the Charles City Facility, while collecting and maintaining requirements for the facility for process workflows. They will work with a development team to validate and deploy updated processes.

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.

Education, Experience & Licensing Requirements

• Bachelors or Master's Degree in life science or computer science/IT.
• 3+ years of experience preferred in configuration and administration of Laboratory Information Management Systems (LIMS).
• Experience supporting and integrating lab applications in a regulated industry.
• Experience with 21 CFR Part 11, data integrity best practices and computerized system regulatory compliance.
• Knowledge of cGMP manufacturing.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affiantive Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

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