Document Control Specialist

Summary:

The Document Control Specialist stores, manages and tracks records and documents. They also ensure that those documents are accurate and maintain their quality and integrity. A Document Control Specialist makes sure the organization follows document retention policies and retrieves those documents upon request. They also archive inactive records and documents.

Responsibilities:
● Responsible for the filing of standard operating procedures
● Acquires approval from R&D, QA and manufacturing after master batch record is created
● Responsible for filing master batch records and issuing batch records for manufacturing
● Reviews and files Equipment Cleaning and Use records
● Creates specification and test records for finished packaged product and prepares master
packaging record
● Responsible for creating and issuing packaging records for process
● Ensures all completed batch and packaging records are systematically filed and can easily be
retrieved
● Responsible for maintaining and disposing of quality records
● Responsible for keeping all validation and control documents
● Review of raw material and component testing records
● Responsible for all COA requests
● Perform any work required for non-routine projects as defined by upper management

● Other duties as assigned

Abilities/Skills/Knowledge Requirements:

• Familiarity with project management
• Basic knowledge of FDA cGMPs
• Hands-on experience with MS Office and Google Suite
• Knowledge of Electronic Document Management Systems (EDMS)
• Proficient typing and editing skills
• Data organization skills
• Attention to detail