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Document Management Specialist

The Steely Group

Uxbridge, MA

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JOB DETAILS
SKILLS
Cross-Functional, Document Management, Document Tracking, Documentation, Documentation Format, GCP (Good Clinical Practices), High School Diploma, Maintain Compliance, Problem Solving Skills, Project/Program Management, Proofreading, Quality Control, Regulations, Regulatory Compliance, Research & Development (R&D), Standard Operating Procedures (SOP), Support Documentation, Technical Editing, Technical Support, Time Management
LOCATION
Uxbridge, MA
POSTED
30+ days ago

The Controlled Documentation Lead supports end-to-end lifecycle management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes quality control, template adherence, and milestone tracking. The lead works closely with stakeholders to coordinate document workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the electronic document management system.

Responsibilities:
  • Coordinate and manage 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 in-depth technical editing and proofreading support to maintain consistency with approved templates and formatting standards.
  • Conduct rigorous QC checks to ensure all documents meet regulatory, procedural, and formatting requirements.
  • Maintain and update controlled document templates and ensure consistent application across documents.
  • Support audits and inspections through documentation readiness activities.
  • Collaborate with cross-functional teams to execute document-related tasks and resolve workflow issues

Qualifications:
Bachelor’s degree and 2 years of directly related experience
OR
Associate’s degree and 6 years of directly related experience
OR
High school diploma / GED and 8 years of directly related experience
  • 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 and inspection readiness.

About the Company

T

The Steely Group

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