Quality Assurance/CSV Specialist (PLM & FDA)

Description

Job Title: Quality Assurance / Computer System Validation (CSV) Specialist

Duration: Contract

Location: Cary, IL

Rate: Up to $50/hr on W2

Work Authorization: (Add if applicable)

Position Summary

We are seeking a Quality Assurance / Computer System Validation (CSV) Specialist to support the implementation and validation of a new Product Lifecycle Management (PLM) system.

This role will focus on system validation, data migration, User Acceptance Testing (UAT), and ensuring compliance with GxP and FDA regulations throughout the implementation lifecycle.

Key Responsibilities

• Support PLM implementation, configuration, and system validation activities.

• Gather business requirements and translate them into functional and testable requirements.

• Develop and execute User Acceptance Testing (UAT) plans and test scripts.

• Author and maintain CSV documentation including:

• User Requirements Specification (URS)

• Functional/Design Specifications (FS/DS)

• Risk Assessments

• Requirements Traceability Matrix (RTM)

• IQ/OQ/PQ Test Protocols

• Validation Summary Reports

• Support PLM workflows, data migration, roles, permissions, and integrations.

• Track defects, support issue resolution, and ensure successful testing completion.

• Collaborate with IT, Quality, Validation, and Business teams to ensure regulatory compliance.

• Develop process documentation, work instructions, and user guides.

• Support audit readiness and system go-live activities.

Must-Have Skills

• 3+ years of Computer System Validation (CSV/CSA) experience
• Strong experience authoring validation documentation (URS, IQ/OQ/PQ, RTM, Risk Assessments)
• Experience with User Acceptance Testing (UAT)
• GxP, cGMP, 21 CFR Part 11 regulated environment
• Experience gathering business requirements and translating them into functional requirements
• PLM or Document Management System experience
• Strong documentation and technical writing skills
• Experience supporting software implementation projects
• Excellent analytical and communication skills

Preferred Skills

• PLM platforms such as Agile PLM or MasterControl
• Manufacturing Execution Systems (MES)
• Data migration and system integrations
• Defect management and testing tools
• FDA-regulated Medical Device or Life Sciences industry experience