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Documentation Specialist I_US
$83,200 - $94,224/Yr
Adecco - Princeton, NJ
posted about 2 months ago
Full-time - Entry Level
Princeton, NJ
Administrative and Support Services
About the position
The Documentation Specialist I position at Adecco Healthcare & Lifesciences involves 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, ensuring that documentation meets regulatory requirements.
Responsibilities
- Facilitate quality system document control activities in compliance with FDA regulations, ISO standards, 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 (SharePoint, 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
