Documentation Clerk- clerical and administrative support

Cube Hub Inc.; Town of Ridgeway (NY); On-site; USD 10,000 - 60,000; Full time

Job summary

Join an innovative firm as a Documentation Clerk, where you will play a vital role in supporting Quality Assurance documentation systems. This position involves electronic archival of Manufacturing Device History Records, ensuring compliance with established procedures. You will utilize your organizational skills and attention to detail to maintain accurate records and assist in troubleshooting document scanning issues. If you thrive in a manufacturing environment and are eager to contribute to quality assurance processes, this role offers a great opportunity for growth and development.

Qualifications

• Basic knowledge of office equipment and computer operations.
• Good verbal and written communication skills are essential.

Responsibilities

• Assist with record archival and ensure compliance with regulations.
• Prepare and verify Device History Records for accuracy.

Skills

Microsoft Office Suite

Attention to detail

Organizational skills

Verbal communication

Written communication

Ability to multitask

Education

High School diploma or equivalent

1-2 years office experience

Tools

Document scanning equipment

Desktop computer

Job description

Documentation Clerk - clerical and administrative support

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This range is provided by Cube Hub Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$18.00/hr - $21.00/hr

Direct message the job poster from Cube Hub Inc.

Job Description

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.

Essential Functions

1. Assist the Quality Assurance function with record archival, storage, and destruction, ensuring compliance with regulations and standards.
2. Prepare DHR records, including removal of staples, ensuring accurate pagination, and compiling Device Serial Number and Software Version information for transfer to the Global Servicing Platform (GSP).
3. Scan DHR records using dedicated equipment to produce true copies.
4. Verify scanned copies for clarity, completeness, and legibility.
5. Perform record archival or destruction according to the Records Retention Schedule and established procedures.
6. Troubleshoot document scanner issues.
7. Maintain document filing and archiving, including offsite storage.
8. Perform other duties as assigned.

Qualifications, Knowledge, and Skills

• Basic knowledge of office equipment.
• Working knowledge of computer operations and Microsoft Office Suite.
• Good verbal and written communication skills.
• Attention to detail and ability to prioritize workflow.
• Strong organizational skills.
• Ability to multitask and work independently.
• Ability to identify errors and escalate issues.
• Responsiveness to customer needs within scope.
• Ability to follow instructions and complete routine tasks.

Education/Experience

• High School diploma or equivalent.
• 1-2 years office experience preferred.
• Basic computer and word-processing skills.

Physical Demands

Must be able to sit, stand, bend, stretch, walk, and lift at least 25 lbs. Reasonable accommodations may be provided for disabilities.

Work Environment

Manufacturing environment regulated by the FDA, requiring PPE and adherence to work rules to prevent product damage. Environment is temperature and humidity controlled.