Documentation Specialist I_US

$83,200 - $94,224/Yr

Adecco - Princeton, NJ

Full-time - Entry Level

Princeton, NJ

Administrative and Support Services

About the position

The Documentation Specialist I position is focused on managing document control activities in compliance with U.S. and international regulations within the medical device or pharmaceutical industry. The role requires a strong understanding of quality standards and a commitment to maintaining high-quality processes.

Responsibilities

• Facilitate quality system document control activities in compliance with FDA regulations, ISO standards, European Medical Device Directives, and other international regulations.
• Manage Document Change Orders for corporate quality system documents, including changes and training.
• Collaborate with document authors to release and implement Global Standard Operating Procedures (GSOPs).
• Participate in Change Review Board meetings.
• Operate within Integra's corporate document control and training systems to manage changes to quality system documents.
• Support quality system training and manage training requirements in the Learning Management System (LMS).
• Execute change orders in alignment with quality system priorities and the global QMS Roadmap.
• Engage in projects related to corporate document control activities.

Requirements

• Minimum bachelor's degree in a relevant discipline (Science, Engineering, Mathematics, Computer Science, etc.).
• 1-3 years in the medical device/pharmaceutical industry.
• Knowledge of QSR/GMP (21 CFR Part 820) regulations and ISO (ISO 13485) standards.
• Strong oral and written communication skills.
• Effective interpersonal skills.
• Ability to multitask, prioritize, and meet deadlines.
• Proficiency in Microsoft Office (Point, PowerPoint, Word, Excel, Adobe Acrobat, etc.).

Nice-to-haves

• Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation.
• Preferred proficiency in training management and product lifecycle management (Agile) systems.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short-term disability
• Additional voluntary benefits
• EAP program
• Commuter benefits
• 401K plan
• Paid Sick Leave
• Holiday pay