Posted to MedZilla on 10/22/2018

Takeda Pharmaceuticals

US-MA, Quality Documentation and Training Specialist II R0004938-MZ


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Job Description


  • Coordinate document workflow and training module administration in LEADs across multiple departments assisting line managers directly.
  • Support Quality File Rooms (QFR s), on and off-site archiving/records management
  • Support Principal Archivist (PA) program, disaster recovery, vital records, and departmental internal audits to ensure compliance with relevant procedures
  • Maintain inspection readiness for documentation, training and archiving. activities for Oncology & Biologics Quality and Operations, TBOS Facilities and TBOS GMA.


  • Perform document submissions, scanning, retrievals and off-site archiving ensuring accuracy with archive indices
  • Support PA Program and projects where applicable
  • Process assigned document types for workflow initiation, to include expiration review compliance
  • Act as customer support liaison to documentation and file room customers
  • Act as primary contact and support to assigned departments for LEADs workflows and training management. Fields questions and issues from functional staff.
  • Create and manages training modules in LEADs (sets prerequisites, initial & re-training periods, substitutes);
  • Coordinate training assignment for employees in assigned areas
  • Provide reports and support as needed for quality audit / inspection activities.


  • High school diploma with 1-3 years experience in pharmaceuticals within GxP environment or Bachelors degree in related subject
  • Prior experience with documentation, archiving/record management systems/processes preferred
  • Strong communication skills
  • Collaborative skills and a strong customer service mindset
  • Proactive, self-directed working style
  • Ability to multi-task and assist in the support of small projects
  • Prior experience using validated documentation and training management systems preferred

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