Document Control Specialist

Document Control Specialist

Location : Carlsbad, CA 92008

Employment Type : Contract

Pay Rate : $32-34 / hr depending on experience

Job Description

Document Control Specialist I Position Summary

The Document Control Specialist I is responsible for executing change control processes to ensure the standardization, accuracy, and completeness of documents prior to release. This role represents Quality Assurance (QA) and collaborates with cross-functional departments to provide quality system guidance. The Document Control Specialist I also maintains the MasterControl document management system and supports continuous improvement initiatives within the quality system.

Essential Duties & Responsibilities

• Create and maintain Document Control quality system procedures and quality documents.
• Maintain controlled copies of quality documents in both hard copy and electronic databases.
• Index, file, archive, and manage off-site storage of controlled quality and corporate records.
• Execute change control processes, ensuring accuracy, completeness, and compliance prior to release.
• Collaborate with cross-functional teams to ensure timely processing of protocols, reports, and validation documentation.
• Provide guidance on good documentation practices (GDP) and ensure compliance with regulatory requirements.
• Support maintenance of design history files, device master records, and technical files.
• Assist Operations with part number control and bill of materials (BOM) maintenance in the ERP system following approved change orders.
• Provide training to employees on using MasterControl for document and change order processing.
• Conduct QA reviews of calibration and preventive maintenance records, including scanning and archival.
• Facilitate document retrieval and support during internal and external audits or regulatory inspections.
• Participate in continuous improvement projects related to document control and quality systems.
• Perform other duties as assigned.

Position Requirements

Education & Experience

Technical Skills

General Skills