Documentation Specialist

$50,752 - $88,109/Yr

Kelly Services - Princeton, NJ

Full-time - Entry Level

Onsite - Princeton, NJ

Administrative and Support Services

About the position

The Documentation Specialist role at Kelly Services involves managing quality system document control activities in compliance with various regulatory standards. This position is crucial for ensuring that documentation processes align with FDA regulations, ISO standards, and other international requirements. The role requires collaboration with document authors and participation in quality system training and management, making it essential for maintaining the integrity of corporate documents and procedures.

Responsibilities

• Facilitation of quality system document control activities in compliance with U.S. and International requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International Regulations.
• Facilitates Document Change Orders for corporate quality system documents including document changes and training.
• Collaborates with document authors to release and implement Global Standard Operating Procedures (GSOPs).
• Participates in Change Review Board meetings.
• Operates in Integra's corporate document control and training systems to transact changes to quality system documents.
• Supports quality system training and management of quality system training requirements in LMS.
• Executes change orders in alignment with quality system priorities and the global QMS Roadmap.
• Participates in projects linked with corporate Doc Control activities.
• Works in collaboration with process owners to update corporate documents (policies and procedures).
• Ensures that changes are processed in the Electronic Document Management system in compliance with internal procedural requirements.
• Collaborates with other team members to have the change reviewed and appropriate training.

Requirements

• Bachelor's degree in a Science/Engineering Mathematics, Computer Sciences or other relevant discipline.
• Minimum of 1-3 years of overall experience in the medical device/pharmaceutical industry.
• Demonstrated knowledge of QSR/GMP (21 CFR Part 820) regulations and ISO (ISO 13485) standards.
• Strong oral and written communication skills and 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.
• Proficiency in training management and product lifecycle management (Agile) systems.

Benefits

• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
• Access to a retirement savings plan.
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year).
• Transit spending account.
• Paid sick leave under the applicable state or local plan.