General Scope and Summary

　　SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a key role as a Document Control Associate Consultant that is responsible for organizing the lifecycle of documents in the electronic Document Management System as well as maintaining the Quality Systems archive of records stored both onsite and offsite.

　　Roles and Responsibilities

　　· Maintain logs and document inventories to ensure traceability and chain of custody.

　　· Oversee upload of records into the electronic Document Management System (eDMS), in compliance with regulatory requirements.

　　· Support program efforts for certified copy creation, which includes scanning and reviewing records.

　　· Provide support during internal and external audits as part of continuous improvement and inspection readiness.

　　· Handle multiple tasks, take initiative, and independently follow through with responsibilities.

　　· Perform additional responsibilities assigned by manager.

　　Experience, Education and Specialized Knowledge and Skills

　　Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. The individual will need to be able to effectively communicate with various stakeholders and Quality Assurance team members at varying levels throughout the organization. The Document Control Associate will need excellent organizational skills and attention to detail, as well as be diligent and flexible.

　　Basic Qualifications

　　· Associate degree

　　· Must be able to lift 25 lbs.

　　· Must be willing to work onsite 4 days a week.

　　Preferred Qualifications

　　· 1+ year applicable pharmaceutical/biotechnology industry experience and/or records and archive management preferred

　　· Proficient with using MS Office (e.g., Word, PowerPoint, and Excel).

　　· Expertise with Microsoft and Adobe products (e.g., SharePoint, Visio, and Acrobat Pro).

　　· Experience working in an electronic Document Management System, including Veeva Vault Quality Docs.

　　· Knowledge of GxP regulations, particularly pertaining to quality systems requirements.

　　· Excellent communication skills (interpersonal, verbal, and written) and collaboration skills.

　　· Experience building relationships and working with internal and external stakeholders.

　　· Detail oriented and self-motivated.

　　· Able to work effectively independently and as part of a team.

　　· Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

　　· Excitement about the vision and mission of Sage.

　　Protected personal characteristics include: age, race, ancestry, color, sex, national origin, sexual orientation, gender identity or expression, religious creed, mental or physical disability, pregnancy, genetic information, marital or civil union status, participation in the uniformed services of the United States, or any other characteristic protected under applicable federal, state or local law. To learn more, see Sage's Anti-Harassment and Equal Opportunity Policy