Document Management Specialist
ADVANCED BIO-LOGIC SOLUTIONS, Thousand Oaks, CA, United States
Location:
Remote
- Thousand Oaks, CA
Employment Type:
Contingent Worker (Contract, W2)
Contract Length:
12 months (possible extension)
Compensation:
$38/$42 per hour (based on experience)
Summary of the Role
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
Remote
- Thousand Oaks, CA
Employment Type:
Contingent Worker (Contract, W2)
Contract Length:
12 months (possible extension)
Compensation:
$38/$42 per hour (based on experience)
Summary of the Role
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