QC Systems Specialist

Rang Technologies Inc; Bend (OR); On-site; USD 85,000 - 110,000; Full time

Job summary

Rang Technologies Inc in Bend, OR is seeking an experienced QC Systems Specialist 1 to support QC systems implementation, integration, and validation in a GMP-regulated pharmaceutical environment.

You will translate URS into practical solutions, support UAT, collaborate with IT, QA, and external system integrators, and help with MES, SAP, and CDS integrations while reviewing FS/DS and ensuring GMP/CSV compliance. Travel between Bend and Tumalo sites is required.

Qualifications

• Bachelor's degree in Science or related field.
• GMP and CSV compliance knowledge is required.
• Strong communication, stakeholder management, and problem-solving skills.

Responsibilities

• Translate URS into practical system solutions.
• Support User Acceptance Testing (UAT) and execute business test cases.
• Collaborate with IT, QA, and external system integrators.
• Support system integrations involving MES, SAP, and CDS.
• Review and validate FS and DS.
• Identify system issues, assess risks, and coordinate resolutions.
• Ensure compliance with GMP and CSV requirements.

Skills

GMP knowledge

CSV knowledge

Stakeholder management

Problem solving

Education

Bachelor's degree in Science or related field

Tools

LabVantage LIMS

SAP

MES

CDS

Job description

We are looking for an experienced QC Systems Specialist 1 to support QC systems implementation, system integration, and validation activities within a GMP-regulated pharmaceutical environment.

• Translate User Requirements Specifications (URS) into practical system solutions.
• Support User Acceptance Testing (UAT) and execute business test cases.
• Collaborate with IT, QA, and external system integrators.
• Support system integrations involving MES, SAP, and CDS.
• Review and validate Functional Specifications (FS) and Design Specifications (DS).
• Identify system issues, assess risks, and coordinate resolutions.
• Ensure compliance with GMP and Computer System Validation (CSV) requirements.
• Bachelor's degree in Science or a related scientific discipline.
• Minimum 3 years of relevant experience.
• Strong understanding of Quality Control (QC) laboratory processes.
• Experience with LIMS (Laboratory Information Management Systems).
• Knowledge of GMP, CSV, URS, UAT, and system validation.
• Strong communication, stakeholder management, and problem-solving skills.

Preferred Qualifications:

• Hands-on experience with LabVantage LIMS.
• Previous QC experience in pharmaceutical or biotechnology environments.
• Experience with change management and system implementation.
• Familiarity with MES, SAP, and CDS integrations.

Additional Requirement:

Candidates must be comfortable traveling between the Bend and Tumalo sites.

“We are an equal opportunity employer. It is our policy to provide employment, compensation, and other benefits related to employment without regard to race, color, religion, sex, gender, national or ethnic origin, disability, veteran status, age, genetic information, citizenship, or any other basis prohibited by applicable federal, state, or local law.”