Massachusetts Veterans Jobs

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.

Qualifications Required:

• S. degree and 8+ years of experience or M.S. degree and 6+ years of experience in a related function, preferably in a biologics manufacturing facility.

• Possess strong computer and Internet skills, including online document management experience and proficiency in Microsoft Office (Outlook, Excel, Word, & PowerPoint).

• Experience with Electronic Document Management Systems.

• Excellent oral and written communication skills.

• Demonstrated knowledge of cGMPs.

• Exhibits a good understanding of general quality assurance concepts and practices.

• Highly organized with a strong attention to detail.

• Successful history of solving problems of moderate complexity.

• Proven ability to manage both day-to-day operations, as well as project work in a fast-paced environment.

• Familiar with project management methodology and process.

Preferred:

• Experience in a small company and high growth, fast-paced environment.

• Experience with Veeva Vault, MasterControl and implementation of an EDMS.

• Familiar with applicable US and international regulatory requirements (e.g., 21 CFR Parts 11, 210, 211, 820).

• Experience supporting regulatory inspections.

Working Conditions:

• This position is based in Westborough, MA and will require on-site work.

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.

• This is an on-site role working in a cGMP regulated manufacturing facility.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

#LI-TD

Category BioPharma QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans