Quality Specialist Document Controls

The Quality Specialist, Document Controls is responsible for the end-to-end lifecycle management of controlled documents within a highly regulated clinical trial technology environment. This role ensures that all quality documentation — including Standard Operating Procedures (SOPs), Work Instructions (WINs), policies, forms, and associated records — is authored, reviewed, approved, distributed, and retired in strict accordance with GCP, FDA 21 CFR Part 11, EU Annex 11, and applicable ICH guidelines.

The Specialist serves as a subject matter expert and primary point of contact for document control activities within the Quality Management System (QMS), supporting inspection readiness, audit preparation, and continuous improvement of the document management framework. The role acts as a critical enabler of quality culture and compliance confidence across the organization.