Senior Document Specialist
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a Senior Document Specialist opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
The Specialist, Document Control has responsibilities the technical and administrative support of the GxP regulated functional departments and their clients. Activities will include, but are not limited to, management and editing of the Electronic Document Management System (EDMS) and its contents, maintaining GxP records in the QA archive, and providing end user customer support.
Essential Job Responsibilities:
Implement, maintain, and continuously improve the document management system and other processes associated with control of documents and records; strategic initiatives to improve controlled document management and issuance processes, governance procedures, and electronic systems. Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks. Facilitate the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator. Execute duties associated with controlled documents; review, edit, format master documents according to approved procedures and templates, maintains document properties (metadata), monitor document status and approval notifications, distributions, and archiving. Issue effective documents including logbooks, procedures, test methods, specifications, batch documentation and labels and maintain issuance logs. Coordinate and perform routine audits of documents maintained to ensure that all documents are reported and current. Assist with end-user training for new users and provide on-going user support for electronic document management system; metric generation and reporting for Quality management. Provides day-to-day operation support for departments (e.g., scheduling, reporting, records archiving). Manage storage database run reports for retention and metrics. May also support the preparation and hosting of internal audits and regulatory (e.g., FDA, EMA, DHHS, etc.) inspections. Performs other duties as assigned or special projects as needed.