Document Control Associate

Position Summary

Maintains and implements change management system in support of quality systems and practices to meet the company, customer and regulatory requirements.

Essential Duties and Responsibilities

• Reviews, routes and releases controlled documents within electronic document control software.
• Creates and manages user accounts in the electronic document control software.
• Maintains and monitors training records.
• Assist in maintaining logs for other quality activities; non-conforming material, service, etc.
• Other duties as assigned (back up for quality inspection, etc).

Supervisory Responsibilities

None

Education, Qualifications and Skills

• High school diploma or equivalent.
• Works under general supervision with some latitude for independent judgment.
• Must have experience with Microsoft Word, and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
• Experience with 21CFR820, Quality Systems Regulation and ISO 13495 desired.
• Must demonstrate a high level of attention to detail in completion of tasks and cross-referencing of information in several logs.
• Must demonstrate the ability to multi-task and prioritize in a fast-paced environment, and possess flexibility when juggling numerous projects simultaneously.
• Must grasp instructions and information rapidly and apply them with little supervision Self-motivated, self-starter.
• Ability to work quickly and efficiently with only initial direction Excellent organizational skills.

Work Environment

This job operates in a clerical, office, as well as a manufacturing setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust or airborne particles, moving mechanical parts and vibration. The noise level in the work environment and job sites can be loud. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.