Software Quality Analyst - ERP & Validation Expert
Terumo BCT, Inc.
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Job summary
Terumo Blood and Cell Technologies in Lakewood, CO is hiring a Software Quality Analyst to provide technical expertise in software validation, testing and documentation across ERP, QMS/PLM, HRIS and CRM systems. You will develop requirements, test plans and scripts, and validate global enterprise apps including SAP ERP and Salesforce/ServiceMax.
Strong communication and precise documentation are essential. Knowledge of FDA CFR Part 11, minimal supervision, and focus on audit-ready validation
Qualifications
- Bachelor's degree in computer science or equivalent.
- Minimum 2 years of experience in software validation.
- Experience validating ERP, QMS/PLM, HRIS and CRM.
- Knowledge of FDA CFR Part 11 regulatory requirements.
- Excellent documentation and written/verbal communication.
Responsibilities
- Performs software validation testing and documentation per QMS/P
- Develops user/functional requirements, test plans and scripts.
- Validate global enterprise apps: SAP ERP, QMS/PLM Windchill, SAP Successfactors, CRM Salesforce/ServiceMax.
- Collaborates with team to deliver on-time validated software to production.
- Analyzes problems and designs solutions.
Skills
Education
Tools
Job description
Terumo Blood and Cell Technologies in Lakewood, CO is hiring a Software Quality Analyst to provide technical expertise in software validation, testing and documentation across ERP, QMS/PLM, HRIS and CRM systems. You will develop requirements, test plans and scripts, and validate global enterprise apps including SAP ERP and Salesforce/ServiceMax.
Strong communication and precise documentation are essential. Knowledge of FDA CFR Part 11, minimal supervision, and focus on audit-ready validation
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