Job Description

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 of 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 QA Documentation Specialist opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The GMP Document Control Specialist will assist in maintaining and administering all aspects of the GMP document control system compliant with international cGMP expectations and Astellas policies and procedures. 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. Quantitative Dimensions: * The flow of GMP documents is essential to the operation of a cGMP manufacturing facility. This role provides critical site documentation support for ongoing GMP operations at a cell therapy manufacturing facility. Delays in support have direct, proportional impact to operations timelines. Organizational Context: * Reports to the Supervisor of Document Control & GMP Training and is part of the larger QA Operations team. * This position has no direct reports Qualifications: Required: * BA/BS or equivalent with typically 0-3 years relevant experience * Familiarity with most major elements of job description, direct experience with at least one major area. * Basic familiarity with FDA regulations including Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations, FDA Guidance, and ICH Guidance. * Proficiency with Microsoft Word formatting tools and techniques, to include manipulation of headers / footers, page control, document sections, orientation, and editing markup / tracked changes. Preferred: * Master's degree * Experience using document management software in a regulated industry. * Proficiency in MS Excel, PowerPoint, and/or Visio to include creation / formatting of charts and data tables. * Experience in an environment subject to regulatory audits. Benefits: * Medical, Dental and Vision Insurance * Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down * 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-JA1 Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled more