LIMS Specialist

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

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.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• 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 Specialist will configure, support, maintain and administer the LIMS database, collecting and storing data for pharmaceutical commercial operations. The position will interpret needs of the business through analysis to create LIMS set up needs.

Responsibilities

• Configure and maintain LIMS modules to support QC testing, inventory management, raw material testing/release, cleaning validation and integration with other computerized 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.

Qualifications/Skills

• Knowledge of cGMP manufacturing

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.

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 / Aff… 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.