Overview

Document Control Specialist Jobs in United States at Nectero Therapeutics

Title: Document Control Specialist

Company: Nectero Therapeutics

Location: United States

Company Description Nectero Therapeutics, the operating name of Nectero Medical, Inc., is a clinical-stage biotechnology company focused on developing innovative therapies for aneurysmal disease. The organization is dedicated to advancing treatments that have the potential to significantly improve patient outcomes and quality of life. As a growing company in the biotech sector, Nectero Therapeutics offers opportunities to contribute to cutting-edge clinical research and development. Team members collaborate across disciplines to support the progression of novel therapies from concept through clinical evaluation. The company values precision, compliance, and a strong commitment to patient-focused innovation.

Position Summary: The Document Control Specialist is responsible for supporting the company’s Quality Management System (QMS) through the formatting, organization, routing, filing, and maintenance of controlled documentation. This role ensures documents are accurate, properly formatted, compliant with internal standards, and processed efficiently through the electronic document management system (eDMS).

The ideal candidate is highly organized, detail-oriented, and possesses strong written communication skills, with advanced proficiency in Microsoft Word and document formatting.

Essential Duties and Responsibilities: The essential functions include, but are not limited to the following:

  • Format technical and quality documents in accordance with company templates, style guides, and document control procedures.
  • Review documents for formatting consistency, grammar, spelling, readability, and compliance with internal standards.
  • Manage document workflows within the electronic document management system (eDMS), including routing, review, approval, issuance, revision, and archival.
  • File and maintain controlled documents and records in accordance with company procedures and regulatory requirements.
  • Maintain document logs, trackers, and metadata within computerized systems.
  • Ensure document version control and retention practices are maintained accurately.
  • Assist departments with document preparation, templates, formatting questions, and document lifecycle processes.
  • Support inspections and audits by retrieving requested documentation in a timely manner.
  • Identify opportunities to improve document control processes and formatting standards.
  • Perform administrative support functions for the QMS, including filing of training records, document uploads, and records management.

Qualifications

Required Skills

  • Excellent written communication and proofreading skills.
  • Advanced knowledge of Microsoft Word, including:

Styles and templates,

Headers/footers,

Automatic tables of contents,

Section breaks and pagination,

Formatting consistency,

Track changes and document review tools.

  • Strong attention to detail and organizational skills.
  • Ability to manage multiple documents and priorities simultaneously.
  • Ability to work independently while maintaining accuracy and timelines.
  • Strong follow-up and coordination skills.
  • Proficiency with Microsoft Office Suite (Word, Excel, Outlook).

 

Preferred Attributes

  • Familiarity with Good Documentation Practices (GDP).
  • Understanding of regulated documentation requirements (FDA, ISO, GMP, etc.).
  • Experience formatting SOPs, work instructions, protocols, reports, and technical documents.
  • Professional, collaborative, and service-oriented approach.

Working Conditions

  • Remote 
  • Frequent computer-based work and document review activities
  • Interaction with cross-functional departments including Quality, Regulatory, Product Development / R&D / Chemistry, Manufacturing and Controls.

 

Physical Environment 

  • Office, home. (*not an all-inclusive list)

 

Physical Requirements:

  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to travel up to 20 %.
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