Quality Management Specialist

The contractor in this role will support the update and alignment of Quality Management System (QMS) documentation to reflect the functionality and processes of a new Product Lifecycle Management (PLM) system. They will collaborate closely with the project manager and cross-functional teams to ensure documentation and training materials align with updated process flows introduced through PLM implementation. In addition, the contractor may assist with User Acceptance Testing (UAT) and contribute to the development of training content to support successful adoption of the new system.

• Review existing QMS documentation, including procedures, work instructions, forms, and templates, to identify areas impacted by the new PLM system.
• Update, rewrite, and reorganize QMS documentation to align with revised PLM workflows, system capabilities, and quality requirements.
• Ensure documentation changes comply with applicable regulatory, quality, and internal standards.
• Collaborate with process owners and subject matter experts to ensure documentation is accurate, clear, and consistent across related QMS documents.
• Navigate the change control process to support timely release of documentation updates.
• Partner with the project team to understand new or updated PLM system functionality.
• Translate system functionality and process flows into clear, user-friendly documentation.
• Assist with creating UAT test scripts and acceptance criteria based on future-state processes.
• Support UAT execution by documenting test results, identifying defects, and tracking resolution.
• Collaborate with functional leads to validate system behavior against business requirements.
• Develop or enhance training materials, including job aids, quick reference guides, SOP walkthroughs, and presentation materials.
• Create task-based instructions to guide end users through new PLM processes and system functionality.
• Work with training teams and subject matter experts to validate training content.
• Support onboarding and training activities by capturing feedback and providing clarifications as needed.

• Bachelor's degree 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.
• Strong technical writing, documentation, and editing skills with exceptional attention to detail.
• Ability to translate complex processes and system tasks into clear, concise, user-friendly documentation.
• Experience supporting User Acceptance Testing (UAT) activities or writing test scripts.
• Strong communication, collaboration, stakeholder communication, and customer service skills.
• Ability to work independently, manage multiple priorities, and collaborate effectively with cross-functional teams and subject matter experts.
• Experience working in a regulated environment, including cGMP, cGDP, and 21 CFR Part 11, preferred.
• High attention to detail, strong organizational skills, and the ability to work effectively in evolving implementation environments.