Documentation Clerk

Stefanini North America and APAC; Town of Ridgeway (NY); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a meticulous Documentation Clerk to support Quality Assurance documentation systems. This role involves clerical and administrative tasks, including electronic archival of Manufacturing Device History Records and ensuring compliance with regulations. The ideal candidate will possess strong organizational skills and attention to detail, thriving in a regulated manufacturing environment. If you are someone who enjoys multitasking and has a passion for maintaining high standards of documentation, this opportunity is perfect for you.

Qualifications

• Basic knowledge of office equipment and computer operations.
• 1-2 years office experience preferred.

Responsibilities

• Provide clerical support for Quality Assurance documentation systems.
• Operate desktop computers and document scanning equipment.
• Assist with record archival and ensure compliance with regulations.

Skills

Microsoft Office Suite

Verbal Communication

Written Communication

Organizational Skills

Attention to Detail

Basic Computer Skills

Education

High School Diploma

Tools

Document Scanning Equipment

Desktop Computers

Job description

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Position Details

Location: Medina, NY (Onsite Work)

Application Contact: Somnath Ghosh, 248 936 5051, [e-mail]

Job Responsibilities

1. Provide clerical and administrative support for Quality Assurance documentation systems under cGMP.
2. Electronic archival of Manufacturing Device History Records (DHRs), including scanning, verification, and transfer.
3. Operate desktop computers with word processing software and document scanning equipment.
4. Assist with record archival, storage, and destruction, ensuring compliance with regulations.
5. Prepare DHR records, including removal of staples, pagination, and data compilation for transfer to GSP.
6. Scan DHR records to produce true copies and verify their clarity, completeness, and legibility.
7. Perform record archival or destruction according to retention schedules.
8. Maintain document filing, including offsite storage as needed.
9. Troubleshoot document scanner issues.
10. Perform other duties as assigned.

Job Requirements

• Basic knowledge of office equipment and computer operations.
• Familiarity with Microsoft Office Suite.
• Good verbal and written communication skills.
• Attention to detail and ability to prioritize.
• Strong organizational skills and ability to multitask.
• Ability to follow instructions and complete routine tasks.

Education and Experience

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

Physical Demands and Work Environment

• Must be able to sit, stand, bend, and lift at least 25 lbs.
• Work in a regulated manufacturing environment with PPE requirements.

Additional Information

Salary ranges vary based on experience and qualifications. Stefanini promotes a fair hiring process, including detailed job discussions before offers.

About Stefanini Group: A global IT and consulting services provider with a CMM Level 5 rating, serving Fortune 1000 clients worldwide.