Documentation Specialist

Documentation Specialist

Position Summary

Support quality documentation and training record management by updating and formatting Quality Operating Procedures and training records, processing document change orders, creating backup files, and filing and distributing quality documents. The role involves approximately 80% computer work and 20% work on the production floor.

Contract to Direct hire $25/hour

Key Responsibilities

• Update and format Quality Operating Procedures and maintain training records.
• Process document change orders and create document backup files.
• File and distribute quality documents; review, verify, and file completed production work orders and supporting documentation.
• Receive and follow verbal and written directions.
• Perform all work in accordance with the quality management system.
• Comply with all safety rules, policies, and procedures.
• Perform additional related duties and functions as assigned, including assignments made without notice.

Education and Experience

• High school diploma or equivalent.
• At least 2 years of experience in a professional office environment.
• Ability to adapt to frequent changes, delays, and unexpected events.
• Detail-oriented approach and ability to work independently and as part of a team.

Skills and Technical Requirements

• Experience with ISO 9001, ISO 13485, and/or cGMP preferred.
• Proficiency in Microsoft Word and Excel, and experience using a production ERP system, preferred.
• Strong organization, multitasking, time management, and attention to detail.
• Strong written and verbal communication skills and excellent comprehension in English required.

Work Requirements

• Authorized to work in the United States without sponsorship.
• Must be able to meet position requirements with or without reasonable accommodation; visual acuity is required to read instructions.
• Required to work onsite at the primary location according to the established schedule. No travel required.