Document Control Associate Consultant

SAGE Therapeutics

SAGE Therapeutics

Cambridge, MA, USA
Posted on Thursday, January 25, 2024

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.

Employment Type:

Contingent Worker

Number of Openings:

1

Job ID:

R002106

#Biotechnology #Careers #ThisIsSage

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.