Document Control Specialist I

FastTek Global; Town of Ridgeway (NY); On-site; USD 35,000 - 55,000; Full time

Job summary

Join a forward-thinking company as a Documentation Clerk, where you will play a crucial role in supporting Quality Assurance documentation systems. This position involves managing the electronic archival of Manufacturing Device History Records, ensuring compliance with Good Manufacturing Practices. You'll utilize your strong organizational and communication skills to assist in record management and troubleshooting document scanner issues. With a commitment to employee well-being, the company offers comprehensive benefits and a supportive work environment, making it an ideal place to grow your career.

Benefits

Medical and Dental

Vision

PTO

Long Term Disability

Life Insurance

401(k) plan with match

Qualifications

• Basic knowledge of office equipment and clerical skills are desirable.
• 1-2 years of office experience preferred.

Responsibilities

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

Skills

Microsoft Office Suite

Attention to detail

Organizational skills

Verbal communication

Written communication

Education

High School diploma

Tools

Document scanning equipment

Desktop computer

Job description

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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

• Assist the Quality Assurance function with record archival, storage, and destruction, ensuring compliance with regulations and standards.
• 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).
• Scan DHR records using dedicated equipment to produce a true copy.
• Verify scanned copies for clarity, completeness, and legibility.
• Perform record archival or destruction following the Records Retention Schedule and established procedures.
• Assist in troubleshooting document scanner issues.
• Maintain document filing and archiving, including filing records checked into Document Control and transferring records to offsite storage as needed.
• 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.
• Strong verbal and written communication skills.
• Attention to detail and ability to prioritize workflow.
• Strong organizational skills.
• Ability to multitask and perform tasks efficiently with minimal supervision.
• Ability to identify errors or faults and escalate issues appropriately.
• Responsiveness to customer needs within the job scope.
• Ability to follow specific instructions and complete routine tasks within provided guidelines.

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

• 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.

Work Environment

• Manufacturing environment regulated by the FDA with specific work rules.
• Wear static protective smock and PPE at all times in designated areas.
• Work in close proximity to others.
• Environment is temperature and humidity controlled.

Additional Info

At FastTek Global, our purpose is our people and our planet. We are committed to helping people find their success stories and acting responsibly in our communities. We have been doing this for 24 years with pride and dedication.

FastTek Global is a financially strong, privately held company focused on consultants and clients, operating across the US, Europe, and India. We differentiate ourselves by being fast, flexible, creative, and honest, working with Fortune 10, Fortune 500, and startup companies.

Benefits

Our benefits include:

• Medical and Dental (FastTek covers most of the cost)
• Vision
• PTO
• Long Term Disability (100% paid)
• Life Insurance (100% paid)
• 401(k) plan with immediate vesting and 3% match

We also offer a referral program and recognition culture. To view all positions, visit: https://www.fasttek.com/fastswitch/findwork