Document Control Specialist [Contractor]

Job Description

Job Description

General Responsibilities :

The Document Control group is a sub-group of Quality Assurance. As such, Document Control is a support group to the Operational Departments of Manufacturing, Quality Control, Facilities and Quality Assurance. The contract Document Control Specialist oversees the process of maintaining all controlled documents and ensures the integrity of all necessary cGMP documentation.

Responsibilities :

• Use Electronic Document Management System to monitor and control documents, ensuring secure and organized storage of both electronic and physical files for the following records : Master Batch Records, Analytical Test Methods, Standard Operating Procedures, Raw Material Specifications, Protocols, Employee Binder, and Training Curricula
• Creates and maintains necessary logbooks for Manufacturing, Quality Control, Facilities and Quality Assurance
• Issues Batch Records, Lab Notebooks, Equipment Logbooks and any other required paperwork to Manufacturing, Quality Control, Facilities and Quality Assurance
• Support Quality Assurance Department, as needed.
• Assists the Document Control Manager in daily operations, as needed.

Issuance of Investigation, Deviation and Change Control numbers, including Event Report Forms to functional departments

Computer Skills :

Education :

Experience :