LIMS QC Systems Specialist - GMP/CSV Integration

Katalyst CRO; Bend (OR); On-site; USD 80,000 - 120,000; Full time

Job summary

Katalyst CRO in Bend, Oregon is seeking an experienced QC integration specialist to support the implementation and validation of a Laboratory Information Management System (LIMS). You will bridge QC business teams, IT, QA and external integrators to ensure the system meets regulatory and operational needs.

Responsibilities include translating URS into practical solutions, guiding testing and validation efforts, and ensuring GMP and CSV compliance across the project.

Qualifications

• Bachelor's degree in science is mandatory.
• Advanced degrees may substitute for the required work experience.
• Minimum of 3 years of relevant professional experience.
• Experience with LIMS implementation, system integration, or laboratory digital transformation is preferred.
• Knowledge of GMP and Computer System Validation (CSV).
• Strong understanding of QC laboratory processes.

Responsibilities

• Translate User Requirement Specifications (URS) into practical system solutions in collaboration with external system integrators.
• Conduct informal User Acceptance Testing (UAT) to verify system functionality before formal testing.
• Support IT and QA teams in delivering high-quality Functional Specifications (FS) and Design Specifications (DS) within agreed timelines.
• Evaluate the business criticality of Phase 2 requirements and recommend process improvements over unnecessary system customization.
• Support system interface implementation and integration with MES, SAP, and CDS.
• Develop, execute, and review business test cases to verify system configuration and functionality.
• Identify critical issues, assess risks, and communicate concerns to relevant stakeholders when required.
• Collaborate with cross-functional teams to ensure smooth system integration and implementation.
• Ensure compliance with GMP and Computer System Validation (CSV) requirements.

Skills

QC laboratory processes

GMP knowledge

UAT understanding

Communication with IT/vendors

Cross-functional collaboration

Education

Bachelor's degree in science

Advanced degrees in Science

Tools

LIMS

LabVantage LIMS

SAP

MES

CDS

Job description

Katalyst CRO in Bend, Oregon is seeking an experienced QC integration specialist to support the implementation and validation of a Laboratory Information Management System (LIMS). You will bridge QC business teams, IT, QA and external integrators to ensure the system meets regulatory and operational needs.

Responsibilities include translating URS into practical solutions, guiding testing and validation efforts, and ensuring GMP and CSV compliance across the project.