Document Control Specialist I

FastTek Global; Medina; On-site; SAR 30,000 - 60,000; Full time

Job summary

An established industry player is seeking a Document Control Specialist to provide essential clerical and administrative support in a manufacturing environment. This role involves managing documentation systems under Good Manufacturing Practices (cGMP), ensuring accurate archival and compliance with regulatory standards. The ideal candidate will possess strong organizational skills, attention to detail, and proficiency in Microsoft Office. Join a dynamic team where your contributions will help maintain the integrity of critical documentation processes in a fast-paced setting.

Qualifications

• 1-2 years of office experience preferred.
• Basic computer and word-processing skills.

Responsibilities

• Assist with record archival and ensure compliance with regulations.
• Scan and verify DHR records for clarity and completeness.

Skills

Microsoft Office Suite

Clerical Skills

Attention to Detail

Organizational Skills

Effective Communication

Education

High School Diploma

Tools

Document Scanning Equipment

Desktop Computer

Job description

Medina, New York Document Control Specialist I #1025100

Job Description:

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.

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 removing staples, ensuring accurate pagination, and compiling Device Serial Number and Software Version information for transfer to 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 procedures.
6. Assist in troubleshooting document scanner issues.
7. Maintain document filing and archiving, including offsite storage transfer.
8. Perform other duties as assigned.

QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED:

• Basic knowledge of office equipment.
• Working knowledge of computer operations and familiarity with Microsoft Office Suite.
• Effective 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 appropriately.
• Responsiveness to customer needs within job scope.
• Ability to follow instructions and complete routine tasks.

EDUCATION/EXPERIENCE REQUIRED:

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

PHYSICAL DEMANDS:

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

WORK ENVIRONMENT:

• Manufacturing environment regulated by FDA.
• Require wearing static protective smock and PPE.
• Work in close proximity to others.
• Environment controlled for temperature and humidity.