Document Management Specialist
Advanced Bio-Logic Solutions Corp., Newbury Park, CA, United States
Job Title
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. Key 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 Required Experience & Skills
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 Top 3 Must Have Skills
1. Project management for documentation workflows 2. Technical editing and document formatting 3. Experience with regulatory documents in a GCP or similar environment Day-to-Day Responsibilities
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 Basic Qualifications
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 This posting is for Contingent Worker, not an FTE
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. Key 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 Required Experience & Skills
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 Top 3 Must Have Skills
1. Project management for documentation workflows 2. Technical editing and document formatting 3. Experience with regulatory documents in a GCP or similar environment Day-to-Day Responsibilities
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 Basic Qualifications
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 This posting is for Contingent Worker, not an FTE