Posted to MedZilla on 3/24/2017

Takeda Pharmaceuticals

US-MA, Quality Documentation and Training Specialist II 1700112-MZ


More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!


The TBOS (Takeda Boston) Oncology & Biologics Quality Documentation & Training group oversees the company s (GXP and non GXP) documentation, training and archiving program and works to ensure that documentation and employee training needs are identified and met. The group manages and administers the company s electronic Documentation and Learning Management Systems, develops and/or sources a range of compliance-related projects, and works to ensure that documentation and training processes are inspection ready employee s training records are well managed.
This role will participate in and support technology initiatives for documentation control and related Quality Systems to include the implementation and of global and cross-divisional Commercial GxP and Non-GxP documentation and learning management systems (DMS/LMS) and associated processes and procedures.
This position is expected to support both the Quality Documentation & Training groups and collaborate with Takeda TPUSA and Global Quality Documentation & Training groups with assigned ongoing operations, projects and goals.
The Quality Documentation & Training Specialist will oversee training and document administration across multiple departments. In addition, the Specialist will perform documentation daily operations, including but not limited to:
    • Working with managers and other quality team members to ensure that inspection readiness is consistently maintained
    • Performing duties pertaining to records archiving and acts as liaison with the Record Operating Center (ROC) in Deerfield where applicable on archiving initiatives
    • Archiving records within the Quality File Room(s) (QFR) and performing on and off-site archiving and records management initiatives that support the Principal Archivist (PA) program. Assisting with disaster recovery and vital record processes and departmental internal audits to ensure compliance with relevant procedures
    • Supporting Archiving (to include Principal Archivist Program) initiatives per project goals and timelines
    • Collaboration with the Takeda Boston (TPUSA & Global) Documentation and Training groups to ensure compliance with relevant projects, processes and procedures


Archiving Documentation Responsibilities
  • Perform daily operations of the Quality File Room operations including, but not limited to 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
  • Perform controlled global document distribution
  • Issue and reconcile controlled document numbers
  • Act as customer support liaison to documentation and file room customers
  • Maintain inspection readiness and support audits/inspections as required
Documentation Responsibilities
  • Ensure documents are processed and initiated into workflows in a timely manner
  • Process assigned document types for workflow initiation, to include expiration/biennial review compliance
  • Track and manage workflows; work with IT if technology issues arise
  • Ensure accuracy of document submissions (e.g. content, template) per departmental procedures
  • Review and approve documentation as assigned by manager
  • Perform controlled global document distribution, where applicable
  • Issue and reconcile controlled document numbers
  • Complete monthly metrics/spreadsheets for documentation activities if so assigned
  • Maintain inspection readiness and support audits/inspections as required
Training Responsibilities
  • Collaborates and takes direction from O&B Documentation and Training management to coordinate training assignment for employees in assigned areas
  • Assigns training to employees and ensures requirements are updated and identifies training that needs to be delivered across functions to include Global documentation
  • Participate on teams with functional area managers and Subject Matter Experts (SMEs) to design, develop, implement, and maintain various training initiatives, programs, and curriculums required. Delivers instructor led training as appropriate
  • Collaborate with SMEs to design, develop, implement and deliver training (where applicable)
  • Assist in preparation of training compliance reports for management notification. Work with functional areas to eliminate late training issues
  • Provides reports and support as needed for audit / inspection activities
  • Evaluate internal processes, suggest process improvements, design/implement quality improvements, and create appropriate documentation
  • Collaborates with other Takeda training areas to continuously improve learning and compliance



  • High school diploma with 1-3 years experience in pharmaceuticals within GxP environment; experience may be substituted for degree
  • Prior experience with archive/records management, documentation, and training systems/processes
  • 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 training management systems preferred


  • Must be able to occasionally lift/feel comfortable moving records (e.g. archive boxes) where applicable
  • Willingness to travel to various meetings or client sites, including overnight trips.

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