Job Description

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

• Must have basic knowledge of office equipment.
• Working Knowledge of computer operations and a familiarity with applicable software packages (Microsoft Office Suite)
• Verbal and written communication skills
• Ability to pay attention to detail and prioritize workflow is essential.
• Strong Organizational skills
• Ability to multitask and perform tasks efficiently with little or no supervision.
• Ability to identify errors or faults in process and escalate issue to appropriate personnel when necessary.
• Able to demonstrate responsiveness to customer needs, within job scope.
• Ability to follow specific directions and complete routine tasks within provided guidelines.

IV. EDUCATION/EXPERIENCE REQUIRED

• High School diploma or equivalent.
• Minimum one (1) – two (2) years office experience preferred.
• Basic computer and word-processing skills.
• Clerical Skills desirable.

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:

• Must be able to sit, stand, bend, stretch and walk throughout the workday
• Must be able to lift at least 25 lbs.
• Work well under tight deadlines

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:

• Wear a static protective smock and Personal Protective Equipment (PPE) at all times while in the designated work areas.
• Work in close proximity to other employees.
• Work in an environment that is temperature and humidity controlled.

Job Tags

Work at office,

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