documentation specialist

$67,725 - $94,598/Yr

Randstad - Princeton, NJ

Full-time - Entry Level

Princeton, NJ

Administrative and Support Services

About the position

The Documentation Specialist role at Randstad US involves managing quality system document control and training activities to ensure compliance with FDA, ISO, and international regulations within the medical device industry. This position is crucial for maintaining high standards in documentation and training processes, contributing to the overall quality management system.

Responsibilities

• Manage quality system document control activities, ensuring compliance with FDA, ISO, European Medical Device Directives, and other international regulations.
• Facilitate document change orders, including document modifications and training coordination.
• Collaborate with document authors to release and implement global standard operating procedures (GSOPs).
• Participate in Change Review Board meetings.
• Use corporate document control and training systems for quality system document changes.
• Support quality system training, managing requirements in the Learning Management System (LMS).
• Execute change orders in line with quality system goals and the global Quality Management System (QMS) roadmap.
• Work with process owners to update corporate policies and procedures, ensuring changes comply with internal requirements.
• Collaborate with team members to review changes and assign appropriate training.

Requirements

• Bachelor's degree in Science, Engineering, Mathematics, Computer Science, or related discipline.
• 1-3 years of experience in the medical device or pharmaceutical industry.
• Knowledge of QSR/GMP (21 CFR Part 820) and ISO 13485 standards is essential.
• Strong oral and written communication and interpersonal skills.
• Ability to multitask, prioritize, and meet deadlines.
• Proficiency in Microsoft Office Suite (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat).

Nice-to-haves

• Familiarity with 21 CFR Part 11 and computer/quality system software validation.

Benefits

• Health insurance
• Incentive and recognition program
• 401K contribution