What are the responsibilities and job description for the Documentation Management Specialist position at Dexian?
Title: GMP Documentation Specialist
Job Summary:
This is an entry-level position responsible for the analysis, development, and operation of quality and risk management systems. The Associate Quality Systems Specialist will provide quality support for the site quality management system and ensure compliance with regulations relevant to the business.
Main Responsibilities:
• Perform project review and audit of Device History Files (DHFs) and technical files including:
• Summary of Safety and Performance reports
• Risk Management plans, reports, FMEAs
• Post-Market Surveillance plans and reports
• Performance evaluation plans and reports including scientific, clinical, and analytical documents
• General Safety and Performance Requirement reports
• Electronically sign as technical approver for quality on applicable documents and within the validated electronic databases.
• Maintain extensive knowledge of Standard Operating Procedures and policies.
• Understand and follow the requirements of the quality system.
• Maintain current training requirements.
• Train other staff members as requested.
• Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies.
• Must be willing and able to work on weekends or extended hours as needed.
About Dexian:
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. We combine the best elements of our core companies to connect talent, technology, and organizations, producing game-changing results that help everyone achieve their ambitions and goals.
Job Summary:
This is an entry-level position responsible for the analysis, development, and operation of quality and risk management systems. The Associate Quality Systems Specialist will provide quality support for the site quality management system and ensure compliance with regulations relevant to the business.
Main Responsibilities:
• Perform project review and audit of Device History Files (DHFs) and technical files including:
• Summary of Safety and Performance reports
• Risk Management plans, reports, FMEAs
• Post-Market Surveillance plans and reports
• Performance evaluation plans and reports including scientific, clinical, and analytical documents
• General Safety and Performance Requirement reports
• Electronically sign as technical approver for quality on applicable documents and within the validated electronic databases.
• Maintain extensive knowledge of Standard Operating Procedures and policies.
• Understand and follow the requirements of the quality system.
• Maintain current training requirements.
• Train other staff members as requested.
• Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies.
• Must be willing and able to work on weekends or extended hours as needed.
About Dexian:
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. We combine the best elements of our core companies to connect talent, technology, and organizations, producing game-changing results that help everyone achieve their ambitions and goals.
