Technical Documentation & Labeling Specialist

Aston Carter • Salt Lake City, UT

4d • $30 - $35 • Onsite

About The Position

Assist in the timely development and completion of labeling documentation, including drawings, change orders, and specifications. Ensure all documentation is accurate and compliant with GMP and QSR standards. Develop labeling designs using standard templates and style guides. Manage digital and hardcopy records within document control systems, resolve discrepancies, and verify that labeling changes are supported by data and consistent with applications.

Requirements

• Proficiency in labeling, document control, and quality assurance.
• Experience with labeling creation software and label printers.
• Proficiency with Adobe Suite, CAD, and SolidWorks.
• Knowledge of regulatory affairs, FDA regulations, GMP, and quality systems management.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication abilities.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong analytical and problem-solving skills.

Nice To Haves

• Bachelor's degree in Engineering, Life Sciences, Technical Communications, Business, Quality, Regulatory Affairs, or a related field.
• Experience in the medical device industry.
• Experience with FDA Quality System Regulations (21 CFR Part 820), GMP, or similar standards.
• Experience with document control, change orders, and PLM systems.

Responsibilities

• Support setup of labeling design using the Neurovascular labeling system and software tools.
• Operate onsite label printers, barcode graders, and other equipment for new or changed labels.
• Troubleshoot printer issues as needed.
• Support labeling verification procedures and collaborate with Operations to implement labeling in production.
• Actively participate in project team meetings, coordinate, and monitor project tasks and progress.
• Uphold the Quality Policy by maintaining compliance with all quality requirements and supporting process improvements.
• Support updates to technical documentation ensuring accuracy and consistency.
• Review and ensure accuracy of technical publications and labeling with attention to detail.
• Maintain documentation compliance using site-specific data management systems.
• Participate in problem-solving initiatives to address technical issues and document resolutions.
• Support updates to departmental and quality system SOPs, Work Instructions, and provide input for training materials.
• Work cooperatively with other functional groups and project managers to coordinate labeling review and approvals.

Benefits

• Medical
• dental
• vision
• Critical Illness
• Accident
• Hospital
• 401(k) Retirement Plan
• 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)

What This Job Offers

• Career Level: Mid Level