Documentation Specialist- Onsite

Job Description:

The Documentation Coordinator I is responsible for the control of Quality Management System (QMS) and quality specific GMP critical documentation.

Key responsibilities include:

• Develops, produces, and maintains a variety of complex technical and user documentation.
• Plans and executes writing projects that need attention to complex technical content.
• Provides effective and useful presentation of that content, and timely reporting of progress in meeting schedule milestones.
• Complex knowledge and utilization of one or more word processing tools.
• Ensuring that document reviews and approvals are managed in an efficient and effective manner.
• Ensuring that all records of document status, outstanding change controls, document reviews, and document approvals are meticulously maintained.
• Ensuring that documents comply with established templates, formats, and identification naming numbering standards.
• Ensuring that document cross-references are accurate and traceable.
• Maintaining the electronic document library and developing and or maintaining a QMS document inventory that includes relevant information regarding document identification, status, effective dating and other pertinent document control information, as required.
• Managing and controlling specific quality records, as required. Distributing and removing controlled documentation to from points of use, as required.
• Ability to determine project requirements, perform complex writing, copy editing, technical editing and documentation design activities.  
• Ability to create document structure and graphics at project level.
• Must have good writing skills.
• The ability to write consistent and clear documentation with the goal of explaining complex information simply and accurately.

Qualifications:

1. Bachelor’s degree OR a high school education and a minimum of 3 years’ experience in a GMP controlled environment.

2. Experience using document control strategies or methods in a GMP controlled environment.

3. Knowledge of MS Office products as well as the ability to learn new systems as required.

4. Ability to communicate using English.

5. Prior experience using word processing, spreadsheet, and presentation software.