Quality Assurance Specialist

Quality Systems Documentation Specialist

Supports Product Lifecycle Management (PLM) implementation by updating Quality Management System documentation, assisting with user acceptance testing, and developing training materials aligned with revised quality processes.

Responsibilities:

• Review, update, and maintain Quality Management System (QMS) documentation to align with new PLM workflows and quality requirements.
• Support PLM implementation by translating system functionality into user-friendly procedures and work instructions.
• Assist with User Acceptance Testing (UAT), including test script development, test execution, defect documentation, and validation.
• Develop training materials, job aids, quick reference guides, SOP walkthroughs, and presentation content.
• Collaborate with project teams, process owners, and subject matter experts to ensure documentation accuracy and support change control activities.

Requirements:

• Bachelor of Science in Science, Engineering, Business, or a related discipline.
• Experience updating and maintaining Quality Management System (QMS) documentation in a regulated environment.
• Familiarity with Product Lifecycle Management (PLM) systems and technical writing.
• Experience supporting User Acceptance Testing (UAT) or developing test scripts.
• Preferred: Experience in cGMP, cGDP, or 21 CFR Part 11 regulated environments.