QA Specialist, Document Control

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 [Register to View] .

This position is based in Westborough, MA and is an onsite position.

Purpose and Scope:

The primary purpose of the Quality Assurance Document Control Specialist is to assist in maintaining and administering all aspects of the GMP document control system compliant with international cGMP expectations and Astellas policies and procedures. Activities will include, but are not limited to, management of the Electronic Document Management System (EDMS) and its contents, word processing and formatting of documents, maintaining GMP records in the QA archive, and providing end user customer support. Participates in independent and team projects as defined by the department supervisor/manager.

Essential Job Responsibilities:

• Assists in maintaining a document management system compliant with regulatory, quality, and AIRM requirements.
• Performs QA document control functions, including document issuance, reconciliation, distribution, release, and archiving of documents.
• Ensures accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems.
• Collaborates with cross-functional departments to ensure timely implementation of document change requests.
• Investigates deviations against the document management system and develops effective corrective action plans.
• May assist in providing training to new staff on document management processes and procedures.
• Supports audits (internal, external) in order to verify that regulatory and quality requirements have been met.
• Coordinates the revision, review, and approval and obsoletion of SOPs and other GMP documents. Responsible for ensuring area managers perform biennial review of all cGMP documents and SOPs.
• Organizes and ensures accurate and reliable filing systems for all paper-based GMP documents.
• Maintain SOP binders and controlled copies.
• Performs other duties as assigned or special projects as needed.

Organizational Context:

• This position reports to the Supervisor, QA Doc Control & Training
• This position is an individual contributor role but is part of the larger QA Operations team.