What are the responsibilities and job description for the Documentation Specialist position at Fusion Life Sciences Technologies LLC?
Description:
Job Title: Documentation Specialist
Location: Princeton, NJ
Work location – onsite or remote? Princeton Headquarter _ Hybrid : 3 days on site (Tuesday, Wednesday, Thursday)
Working Days/Hours? 8 hours per day – day time
Top 3 qualities you are looking for in this worker.
Team work and collaboration,
following established rules and attentive to details, ability to communicate at various level of the hierarchy
Job and Competencies requirements (education, technical organizational and relational skills, etc…)
• A minimum of a bachelor’s degree in a Science/Engineering Mathematics, Computer Sciences or other relevant discipline
• A 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 is required.
• Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation, preferred.
• 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.) is required.
• Proficiency in training management and product lifecycle management (Agile) systems preferred.
Responsibilities
• The position is responsible for facilitation 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 of Global Standard Operating Procedures (GSOPs).
• Participate to Change Review Board meetings.
• Operate in Integra’s corporate document control and training systems to transact changes to quality system documents.
• Support quality system training and management of quality system training requirements in LMS
• Execute change orders in alignment with quality system priorities and the global QMS Roadmap
• Participate to projects linked with corporate Doc Control activities.
Work in collaboration with process owner to update corporate documents (policies and procedures). Make sure that the changes are processed in the Electronic Document Management system in compliance with internal procedural requrements. Collaborate with the other team members to have the change reviewed and appropriate training assigned:
