Document Control Specialist

Job Title: QA Document Control Associate

Location: Rockville MD 20850

Duration: 6 Months

Shift: 8 AM to 5 PM

QA Document Control Associate

Job Purpose

Ensures effective control, accuracy, and compliance of quality documentation within the Quality Management System (QMS) by managing document lifecycle processes, including document review, approval, version control, document inventory management, archival and retrieval, and periodic documentation verification activities.

Key Responsibilities

· Provide support for document control management activities, e.g., document filing, binding, archiving, retrieval, etc.

· Maintain electronic and hardcopy documentation through its lifecycle according to procedural requirements.

· Assist with issuing and verification of documents to support GMP Operations.

· Maintain document inventory of all GMP documents.

· Assist with responding to requests, performing audits and related projects

· Utilize electronic document management systems (Veeva) to manage, track, and control GMP documentation.

· Perform additional document management-related and administrative tasks, as needed.

Educational Background

Job-Related Experience

· Knowledge and understanding of GMP regulations and Document Compliance

· Experience in either Quality Systems, Documentation or Quality Compliance preferred

· Proficient knowledge of Microsoft Office, i.e., Word, Excel, PowerPoint

· Good communication skills

· Good organization skills

· Ability to work in a team environment

· Minimum 6 months to 1 year experience in a Quality organization