Quality Assurance Specialist

Job Summary

Supporting the update and alignment of Quality Management System documentation, the contract Quality Assurance Specialist will collaborate with cross-functional teams and assist with User Acceptance Testing while developing training materials for a new Product Lifecycle Management system in a remote capacity.

Key responsibilities

• Review and update existing QMS documentation to align with revised PLM workflows and ensure compliance with regulatory standards
• Assist in creating UAT test scripts and support execution by documenting test results and tracking defect resolutions
• Develop training materials, including job aids and SOP walkthroughs, to facilitate user understanding of new PLM processes

Required qualifications

• BS in a science, engineering, business, or related discipline
• Experience in a regulated environment, preferably with cGMP and cGDP regulations
• Proven experience updating Quality Management System documentation
• Familiarity with PLM systems and User Acceptance Testing activities
• Strong technical writing skills with the ability to create user-friendly documentation