Specialist, Quality Assurance - Individual Contributor

We are seeking a dedicated QMS QA Specialist to support the update and alignment of Quality Management System (QMS) documentation in line with a new Product Lifecycle Management (PLM) system.

About the role

You will work closely with the project manager and cross-functional teams to ensure that documentation and training materials align with the updated process flows. Additionally, you may assist with User Acceptance Testing (UAT) and contribute to the development of training content to facilitate the successful adoption of the new system.

Responsibilities

• Review existing QMS documentation to identify areas impacted by the new PLM system.
• Update, rewrite, and reorganize documents to align with revised PLM workflows and quality requirements.
• Ensure all changes comply with regulatory, quality, and internal standards.
• Collaborate with process owners and subject matter experts to ensure the accuracy and clarity of documentation updates.
• Ensure consistent implementation of updates across related QMS documents.
• Navigate the change control process to ensure timely release of changes by the system's 'go live' date.
• Partner with the project team to understand new or updated PLM system functionality.
• Translate system behavior and process flows into clear, user-friendly documentation.
• Assist in creating UAT test scripts and acceptance criteria based on future-state processes.
• Support the execution of UAT by documenting test results and tracking resolution.
• Collaborate with functional leads to validate system behavior aligns with business requirements.
• Develop or enhance training materials, including job aids and SOP walkthroughs.
• Create clear, task-based instructions for end users.
• Work with the training team and SMEs to validate the accuracy and usability of materials.
• Support onboarding and training sessions as needed.

Requirements

• Experience with QMS, PLM, and UAT.
• Strong technical writing skills with attention to detail.
• Ability to translate complex processes into clear instructions.
• Experience supporting UAT activities or writing test scripts.
• Strong communication and collaboration skills.

Qualifications

• BS in science, engineering, business, or related discipline.
• Experience in a regulated environment (cGMP, cGDP, 21 CFR part 11) preferred.
• Stakeholder communication and customer service skills preferred.
• Ability to work independently and manage multiple tasks.
• Strong documentation, technical writing, and editing skills.

Work Environment

Join a QMS Quality team in an office environment with the option to work remotely. This role offers the opportunity to work on significant QMS and new PLM projects with the potential for long-term employment.

Pay

The pay range for this position is $40.00 - $44.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a hybrid position in Cary, IL. This is a Contract to Hire role.