Document Management Specialist

Advanced Bio-Logic Solutions CorpThousand Oaks, CA
Remote

About The Position

Support the end-to-end lifecycle management of R&D controlled documents for a big biopharma leader, ensuring compliance with regulatory standards and internal quality procedures. Oversee document workflows and perform rigorous quality control (QC) reviews to maintain consistency and accuracy. Collaborate with cross-functional teams and facilitate document readiness for audits and inspections.

Requirements

  • Strong project management skills, including milestone tracking and workflow oversight
  • High proficiency in technical editing and document formatting
  • Familiarity with regulatory documentation in a GCP or similar environment
  • Experience with document management systems
  • Demonstrated inspection readiness
  • Project management for documentation workflows
  • Technical editing and document formatting
  • Experience with regulatory documents in a GCP or similar environment
  • Bachelor’s degree and 2 years of directly related experience
  • Associate’s degree and 6 years of directly related experience
  • High school diploma / GED and 8 years of directly related experience

Responsibilities

  • Coordinate and manage controlled document workflows (e.g., SOPs, templates) to meet project timelines and compliance standards
  • Track documentation milestones and follow up with contributors to ensure deadlines are met
  • Provide technical editing and proofreading support to ensure consistency with templates and formatting requirements
  • Conduct thorough QC reviews for regulatory, procedural, and formatting compliance
  • Maintain and update document templates to ensure consistent use across all documents
  • Support audits and inspections by preparing documentation and ensuring inspection readiness
  • Collaborate with stakeholders and cross-functional teams to resolve document-related issues
  • Coordinate document workflows and ensure tasks are completed on schedule
  • Track and follow up on documentation milestones with contributors
  • Edit and proofread documents to conform with approved templates
  • Conduct quality control checks for regulatory and formatting compliance
  • Update and maintain document templates
  • Prepare documentation for audits and support inspection readiness
  • Work closely with cross-functional teams to manage document-related activities
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