Training Specialist

Newton , MA

Posted: 04/29/2019 Employment Type: Contract Industry: Life Sciences Job Number: 229266

 
Title:                      Training Specialist
Type:                    Contract
Duration:            6 Months
Location:              Newton, Massachusetts 

Top 3 Technical Skills:
•  GxP training experience 
•  Electronic Document management system experience 
•  ICH Guidelines, FDA and global Regulatory Standards 

The Training Specialist will be responsible for oversight and maintenance of the GxP Training Program. The ideal candidate will establish and maintain a robust, compliant training program for new hires and existing personnel in a fast-paced environment. 

PRIMARY RESPONSIBILITIES:
• Support the development, implementation and maintenance of the GxP training program
• Partner with functional departments to update and maintain staff training matrices based on role-based requirements
• Issue staff training via the training system and monitor completion of training requirements 
• Facilitate onboarding for new hires
• Collect and develop process for retaining training records, including external training activities
• Establish and manage users in the training system
• Facilitate training by assisting with content development and review prior to delivery
• Provide guidance, tools and templates to trainers and managers
• Provide reports and metrics to track the effectiveness of the training program 
• Assemble and update staff training records, ensuring training records are complete and inspection ready
• Partner with the QMS Documentation Team and functional departments to coordinate SOP and Controlled Document training

QUALIFICATIONS:
• BA or AD in a scientific or related discipline
• Quality professional with 1-3 years of hands-on experience with GxP training in biopharmaceutical industry preferred
• Experience with electronic document management systems is required
• Knowledge of ICH Guidelines, FDA and global Regulatory Standards
• Strong technical skills and proficiency in Microsoft Office (including Teams and Visio) and Adobe Acrobat Pro
• Experience using Veeva Vault is a plus

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