Documentation Clerk

Job Description

Job Description

I. SUMMARY :

The Documentation Clerk is responsible for providing clerical and administrative support for Quality Assurance documentation systems under current Good Manufacturing Practices (cGMP). Main responsibilities include electronic archival of Manufacturing Device History Records (DHRs), including scanning, verification, archival, and transfer of DHRs according to established procedures. Operation of a desktop computer using word processing software and document scanning equipment with applicable software are required competencies,

II. ESSENTIAL FUNCTIONS :

Assist the Quality Assurance function with Record archival, storage, and destruction, while ensuring compliance with established regulations and standards.

• Preparation of DHR records including removal of staples, ensuring accurate pagination, and compilation of Device Serial Number and Software Version information for transfer to Global Servicing Platform (GSP), as needed.
• Scanning of DHR records using dedicated equipment with applicable software to produce a “true copy”.
• Verification of scanned copies as true copies i.e. verified to be clear, complete, and legible.
• Perform record archival or destruction according to the Records Retention Schedule and / or established procedures.
• Assist in troubleshooting of document scanner related issues.
• Maintain Document filing and archiving including filing of records checked in to Document Control and transfer of filed records to offsite storage, as needed.
• Perform other duties as assigned

III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED

IV. EDUCATION / EXPERIENCE REQUIRED

V. PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee :

VI. WORK ENVIRONMENT

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to :