Title: Documentation Specialist
Job Type: Contract (C2C, W2)
Location: Piscataway, NJ
Our client, a Fortune 500 Company is seeking a Documentation Specialist who will be responsible for performing document management duties and be responsible for carrying out assigned quality initiatives within the Information Technology department, including but not limited to Standard Operating Procedures (SOPs), training material, computer systems validation documentation.
Duties and Responsibilities:
• Responsible for the preparation, analysis and creation of various technology-based and architectural documentation and procedures
• Ability to elicit requirements / processes from subject matter experts and document those requirements / processes
• Ability to analyse and document complex business processes and work flows, and propose areas for improvement
• Ability to gather data via diverse means (i.e. interviews, observation, surveys, existing written documentation) and interpret relevant information
• Ability to document system flows, interfaces, use cases, and business rules
• Conduct a wide variety of Business / Technical analyses by partnering across a variety of teams along with different levels of management
• Perform document control function, including document tracking, processing, approval, distributing, and archiving in compliance with internal and external requirements
• Coordinate the revision, review, and approval of Standard Operating Procedures (SOPs), Work Instructions, and controlled forms and quizzes, as necessary
• Ensure documents follow the standard format and “proof” review during document initiation or changes to ensure basic requirements are met for specifically required elements (i.e., header, footer, style, formatting, required approvals) and ensure the organization’s needs for documentation structure are met, with compliance to all applicable statutory and regulatory requirements
• Maintain onsite and offsite documentation storage, as applicable
Essential Skills and Requirements:
• A Bachelor’s degree in Computer Science, Information Systems or other related field and a minimum of 6 years’ experience in a pharmaceutical, biotechnology or related environment
• Minimum 4 years’ experience in a role responsible for controlled documents management
• Process / procedure or technical writing experience
• Proficiency with MS Office (Word, Excel, PowerPoint, Outlook, Visio, SharePoint)
• Experience mapping processes using Visio or similar tools
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• *Special knowledge or skills and/or licenses or certificates preferred.
• Experience with developing systems via a structured SDLC methodology
• Experience with testing, training and user support
• Experience with GxP documentation