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Document Control Specialist

Nectero Therapeutics

Remote · Jornada completa

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Experiencia
Cualquier
Salario
Vacantes
1
Al corriente
Hace 4 horas
Modo de trabajo
Trabajar desde casa
Elegibilidad
Candidates in the United States who can work remotely and are able to travel up to 20% may apply.
Reanudar
Se requiere solicitud

Descripción del trabajo

Company Overview

Nectero Therapeutics, which operates as Nectero Medical, Inc., is a clinical-stage biotechnology company developing new treatments for aneurysmal disease. The company is centered on advancing therapies that may meaningfully improve patient outcomes and overall quality of life. As a growing biotech business, it provides the chance to contribute to research and development work at the leading edge of clinical innovation. Team members work across functions to help move novel therapies from early concepts through clinical evaluation, with a strong emphasis on precision, compliance, and patient-centered innovation.

Role Summary

The Document Control Specialist supports the Quality Management System by formatting, organizing, routing, filing, and maintaining controlled documentation. The role keeps records accurate, properly structured, compliant with internal standards, and efficiently processed through the electronic document management system (eDMS).

This position is best suited to someone who is exceptionally organized, highly detail-oriented, and strong in written communication. Advanced Microsoft Word skills and document formatting expertise are especially important.

Key Duties

  • Prepare technical and quality-related documents so they align with company templates, style requirements, and document control procedures.
  • Check documents for consistent formatting, correct grammar and spelling, readability, and alignment with internal standards.
  • Handle document movement in the eDMS, including routing, review, approval, release, revision, and archiving.
  • Maintain controlled documents and records in line with company procedures and regulatory expectations.
  • Update document logs, trackers, and metadata in computerized systems.
  • Keep version control and retention practices accurate and up to date.
  • Help teams with document creation, template use, formatting questions, and document lifecycle tasks.
  • Provide support during inspections and audits by locating and supplying requested records quickly.
  • Look for ways to improve document control workflows and formatting standards.
  • Carry out administrative support for the QMS, including training record filing, document uploads, and records management.

Required Qualifications

The candidate should have strong proofreading ability, excellent written communication, and advanced Microsoft Word knowledge, including working with styles and templates, headers and footers, automatic tables of contents, section breaks and pagination, formatting consistency, and track changes/document review tools. Strong attention to detail, solid organization, and the ability to manage several documents and priorities at once are essential. The role also requires the ability to work independently while maintaining accuracy and deadlines, along with strong coordination and follow-up skills. Proficiency with Microsoft Office Suite, especially Word, Excel, and Outlook, is required.

Preferred Experience

Helpful background includes familiarity with Good Documentation Practices (GDP), knowledge of regulated documentation expectations such as FDA, ISO, and GMP requirements, and experience formatting SOPs, work instructions, protocols, reports, and technical documents. A professional, collaborative, and service-focused attitude is preferred.

Working Conditions

This is a remote position with frequent computer-based work and document review responsibilities. The job involves regular interaction with cross-functional teams, including Quality, Regulatory, Product Development, R&D, and Chemistry, Manufacturing and Controls.

Physical Environment

Work may be performed in office or home settings. This list is not exhaustive.

Physical Requirements

The role involves extended periods of sitting at a desk and working on a computer. The selected candidate must also be able to travel up to 20% of the time.

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