QC Systems Specialist 1

Katalyst-Healthcares-; Bend (OR); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst-Healthcares- is seeking an experienced QC professional to support LIMS implementation and integration. The role will bridge QC business teams, IT, QA, and external integrators to ensure system meets business, regulatory, and operational needs.

The position focuses on translating business requirements into system solutions, supporting testing and validation, and ensuring successful system integration with MES, SAP, and CDS. A strong QC background and experience with LIMS are preferred.

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.
• Strong knowledge of QC laboratory processes and GMP/CSV.

Responsibilities

• Translate URS into practical system solutions with external integrators.
• Conduct informal UAT to verify system functionality before formal testing.
• Support IT and QA in delivering Functional and Design Specifications within timelines.
• Evaluate Phase 2 requirements for criticality and minimize unnecessary customization.
• Support system interfaces with MES, SAP, and CDS.
• Develop, execute, and review business test cases for system validation.
• Identify issues, assess risks, and elevate concerns to stakeholders.
• Collaborate with cross‑functional teams for smooth system integration.
• Ensure compliance with GMP and CSV requirements.

Skills

QC processes

GMP

CSV compliance

Project management

URS/UAT

Test case development

LIMS experience

System validation

Education

Bachelor's degree in science

Job description

Summary

We are looking for an experienced QC professional to support the implementation and integration of a Laboratory Information Management System (LIMS). The individual will act as a key link between QC business teams, IT, QA, and external system integrators to ensure the system meets business requirements, regulatory expectations, and operational needs.

The role involves translating business requirements into system solutions, supporting testing and validation activities, managing cross-functional alignment, and ensuring successful system integration.

Roles & 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 elevate 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.

Education & Experience

• Bachelor's degree in science is mandatory.
• Advanced degrees in Science may be considered in place of the required work experience.

Work Experience

• Minimum of 3 years of relevant professional experience.
• Strong experience and understanding of QC laboratory processes.
• Experience supporting LIMS implementation, system integration, or laboratory digital transformation is preferred.

Technical Skills & Expertise

• Strong knowledge of QC laboratory processes and current/future global quality standards.
• Good understanding of GMP and Computer System Validation (CSV).
• Basic project management skills, including timelines, deliverables, and dependencies.
• Technical understanding to effectively communicate with and challenge IT teams and external vendors.
• Understanding of system integrations involving MES, SAP, and CDS.
• Experience in requirements gathering, UAT, test case development, and system validation.

Preferred / Nice-to-Have Qualifications

• Previous experience working with a LIMS platform.
• Specific experience with LabVantage LIMS is highly preferred.
• Previous Quality Control (QC) experience in a regulated environment.
• Experience in change management and system implementation projects.
• Experience working with global teams and cross-functional stakeholders.

Key Behavioral & Soft Skills

• Decision-Making & Courage: Ability to make and defend important decisions, even when challenging established global standards.
• Strategic Thinking: Ability to balance global consistency with local business requirements and operational feasibility.
• Communication & Negotiation: Strong ability to communicate between business, IT, QA, and external vendors.
• Problem-Solving & Adaptability: Ability to assess risks, resolve challenges, and identify practical solutions.
• Resilience & Persistence: Ability to drive progress despite resistance, ambiguity, or competing priorities.