Quality/Regulatory - Specialist, Quality Assurance

Position Summary
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 that 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 promote successful adoption of the new system.

Essential Duties & Responsibilities
QMS Documentation Updates
Review existing QMS documentation (procedures, work instructions, forms, templates) to identify areas impacted by the new PLM system.
Update, rewrite, and reorganize documents to align with revised PLM workflows, system capabilities, and quality requirements.
Ensure all changes comply with applicable regulatory, quality, and internal standards.
Collaborate with process owners and subject matter experts to ensure accuracy and clarity of updates to documentation.
Ensure updates across related QMS documents are implemented consistently and supporting documents remain consistent.
Navigate the change control process to ensure release of changes by system go live date.

PLM Implementation Support
Partner with project team to understand new or updated PLM system functionality.
Translate system behavior and process flows into clear, user-friendly documentation.

User Acceptance Testing (UAT)
Assist in creating UAT test scripts and acceptance criteria based on future-state processes.
Support execution of UAT by documenting test results, identifying defects, and tracking resolution.
Collaborate with functional leads to validate system behavior aligns with business requirements.

Training Materials
Develop or enhance training materials, including job aids, quick reference sheets, SOP walkthroughs, and slide decks.
Create clear, task-based instructions that guide end users through new PLM processes and system functions, ensuring usability and comprehension.
Work with training team and SMEs to validate accuracy and usability of materials.
Support onboarding and training sessions as needed, such as capturing feedback or providing clarifications.

Education & Special Trainings
BS in a science, engineering, business or related discipline.
Work experience in a regulated environment (cGMP, cGDP and 21 CFR part 11 regulations) preferred.

Qualifications & Experience
Experience updating and maintaining Quality Management System documentation in a regulated environment.
Familiarity with PLM systems.
Strong technical writing skills with exceptional attention to detail.
Ability to translate complex processes and system tasks into clear, concise, user-friendly instructions for end users.
Experience supporting UAT activities or writing test scripts.
Strong communication and collaboration skills
Stakeholder communication and customer service skills preferred
Ability to work independently and manage multiple tasks

Mental Requirements
Strong documentation, technical writing, and editing skills
Strong communication and collaboration skills
Capable of working cross-functionally with SMEs
High attention to detail with strong organizational skills
Comfortable working in evolving implementation environments

Shift Details:
1st Shift: 8:30am-5:00pm CST
Can be remote