Documentation Specialist Jobs

Primary Work Location

Lincoln, NE

Overview

Create, maintain, and control Manufacturing Documents (MD) in an ISO 9001 certified environment that enable the assembly, calibration, and testing of innovative, optical imaging devices, reagents, and accessories that enable researchers to advance the understanding, diagnosis, and treatment of human diseases. Work closely with Research & Development to implement Engineering Change Notices (ECN) making sure that Enterprise Resource Planning (ERP) software has the correct and up-to-date information. Work closely with Engineering and Manufacturing Engineering to create Assembly Procedures (AP) and Standard Operating Procedures (SOP) for new products in development. Maintain and revision control these documents as fixes and/or improvements need to be implemented. Assist in the writing and review of Quality Management Systems (QMS) documentation.

Job Qualifications

Education

Associate Degree or Bachelor Degree in Communications, Technical Writing, Drafting, or other related field is preferred.

Experience

• Knowledge of structure and content of the English language including word definition, rules of composition, and grammar.
• Experience working in an ISO 9001 certified manufacturing environment.
• Experience writing, illustrating, editing, and reviewing technical documents, or abundant experience reading and following technical documents.
• Experience in written and visual media, communication, and dissemination of procedures, methods, and techniques.
• Must be proficient working with computers and common applications such as Outlook, MS Word, Adobe, etc.
• Experience working with Product Data Management (PDM) and/or manufacturing documentation control software is highly desirable.
• Experience working with Net Suite, or another ERP platform.

General

• Effective oral and written communication skills in English. Able to communicate with colleagues in a variety of departments and positions.
• Accuracy and high attention to detail in both task execution and documentation.
• Dependable, positive attitude, and good attendance.
• Energetic and highly motivated. Enjoy challenges. Self-driven to achieve goals.
• Good organizational skills with the ability to manage/prioritize multiple tasks and projects.
• High ethics, integrity, honesty, and patience.
• Team player with good interpersonal skills. Enjoys and works well with other people in a team environment.

Job Functions

SPECIFIC:

• Proactively identify and work towards continuous improvement initiatives that benefit the processes used in creating and maintaining MDs.
• Develop clear, concise, and inclusive lists of consumables, supplies, tools, and equipment to be used in the assembly of various products.
• Work with Engineering, Scientists, and Manufacturing personnel to create APs and SOPs for new products during the transition from development to commercialization. This includes providing written instructions and visual aids to document the processes with necessary detail and clarity.
• Develop and implement improvements to AP format to clarify processes that are organized and sequenced into major sections, including numbering Assembly steps.
• Perform ongoing maintenance of APs and SOPs to reflect changes due to improvements and/or corrections.
• Write, transcribe, and record information to be used in APs, SOPs, and other MDs.
• Analyze visual elements of the APs including digital photographs, video, and technical drawings and align to corresponding tasks and assembly steps.
• Develop and implement consistent verbiage and symbols used in APs to indicate safety precautions, hazard warnings, and cautionary notices.
• Routinely conduct user feedback sessions and/or usability tests with manufacturing personnel. Incorporate suggestions and recommendations to improve visual appeal, overall quality, and general effectiveness of APs.
• Study drawings, specifications, mock-ups, and samples to integrate operating procedures and production sequence and detail in APs and SOPs.

GENERAL:

• Other job-related duties as assigned.
• Take ownership and be the go-to person for questions/tasks related to MDs.
• Manage individual tasks to maintain project schedule.
• Stay up to date with best-in-class practices related to documentation creation and control.
• Develop and maintain constructive and cooperative working relationships with others, including personnel from Research & Development, Manufacturing, Quality Control, and other departments.