Document Control and Archive Specialist Consultant

General Scope and Summary 

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as Document Control and Archive Specialist, responsible for supporting the maintenance of the Document Control and Archive programs while ensuring adherence to internal policies and procedures and regulatory requirements.

Roles and Responsibilities (Essential Functions)

• Analyzes document changes for completeness and alignment with change history.  Ensures the correct and timely implementation of document control requests.  Verifies own work, checks format and compliance with document templates.

• Demonstrates excellent and consistent attention to detail.

• Performs advanced word processing support and assists personnel in resolving complex document format issues.

• Supports and manages documents and records in the electronic Document Management System (EDMS), in compliance with regulatory requirements.

• Supports the compliance of periodic reviews of controlled documents, and the maintenance of the Sage Glossary and Sage Style Guide.

• Provide support during internal and external audits related to internal audits and Health Authority inspections.

• Provide support for investigations into Deviations and CAPAs to ensure activities comply with Sage procedures and regulatory requirements.

• Revises governance and procedure documents that support continuous improvement of documentation systems.

• Maintain archive logs, inventories, indices for documentation to ensure chain of custody traceability

• Coordinate operational efforts related to GxP Records Management program, including record conversion from paper to digital file, applying record retention schedules, working with teams to centralize the storage of records, and supporting data migration efforts.

• Maintaining both hardcopy and electronic records as required per applicable regulations such that required documentation is retrievable and files are accurate, complete, and well organized.  Reviews records for completeness and ensures the correct and timely entry and archival of records.  Verifies own work.

• Lead the scanning program efforts for Certified Copy creation, which may include scanning and reviewing the replica based on established standards

• Ensure data integrity and security of all databases and physical records containing data relevant to product quality and/or Quality Systems processes.

• 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. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Basic Qualifications

• Associates Degree, or equivalent combination of related education and experience.

• 3+ years pharmaceutical industry experience in Documentation Management / Quality Assurance.

• Experience with working in an Electronic Document Management System.

• Knowledge and understanding of Document Control and Archive standards, practices, and principles (i.e., document and record indexing and classification schemes)

• Advanced knowledge with MS Office and Adobe products (e.g., Word, PowerPoint, Excel, Visio, SharePoint and Acrobat Pro).

• Strong attention to detail and the ability to work individually.

• Excellent interpersonal, problem-solving skills.

• Must be able to lift and carry 25 lbs.

• Must be willing to work onsite.

Preferred Qualifications

• 4+ years of Document Control experience in the Pharmaceutical/Biotech industry or equivalent combination.

• An understanding of technical publishing best practices.

• Experience with planning and executing data migrations.

• Knowledge and understanding of Quality Systems and applicable GxP regulations and standards.

• Strong team player that has a customer service approach and is solution oriented.

• Strong written and verbal communication skills.

• Experience with Veeva Quality Docs

Employment Type:

Job ID:

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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.