Position: - Technical Writer

Location: - Lombard IL 60148 (Hybrid 50%)

Duration: - 12 months

Shift: -Standard

Job Description

• The Technical Writer works under the guidance of the Project Manager (PM) and Project Coordinator for the assigned project(s). In this capacity, the Technical Writer ensures the accuracy and efficiency of project and quality documents across all project phases.
• Collaborating closely with the entire project team and stakeholders, the Technical Writer aids in document creation, facilitates communication regarding document management, and offers insights into the workflow status of all documents.

Role scope:

• Aid in implementation of this project and revolve around the project documentation. Updating SOPs working with SMEs creating new. Protocol writing, documentation, administrative burdens, track wise digital to run change control to run through system, documenting. Working inside documentation repository LiveLink to create the docs and push through workflows. In the background, abiding by standards of company.
• Understand complex topics, validation writing, writing documentation with ISO certification or medical device. 1-2 years in GMP qualified field. Higher level of technical writing 75% of job duties writing the documentation.
• Industries preferred: Food, Pharma, Medical Device are main industries with complementary documentation & SOP writing.

Document Creation and Maintenance:

• Develop and maintain project and quality documents in a standardized format and per configuration & documentation management plans.
• Change Coordination:
• Facilitate the change coordination process for document updates for project documents and
• Document Review and Approval:
• Coordinate the review and approval process, collaborating with stakeholders, to ensure document accuracy and completion of reviews and approvals.
• Work with PM and approvers to route project documents in OpenText EDMS and Quality (any controlled) documents in OpenText LLDC.
• Cross-Functional Collaboration:
• Foster collaboration between project managers, quality assurance teams, and other stakeholders for cohesive document development.
• Regulatory Compliance:
• Ensure project and quality documents adhere to relevant site and business requirements.
• Documentation Accessibility:
• Implement access controls to safeguard document confidentiality while ensuring authorized personnel have appropriate access.
• Maintain documents in allocated workspace, per configuration & documentation management plans.
• Communication and Reporting:
• Communicate changes and updates to stakeholders and provide regular reports on document status.
• Adherence to Document Policies:
• Ensure strict adherence to organizational document management policies and standards.
• Technical Writing:
• Ensure consistent formatting and style across all project and quality documents.
• Address reviewer comments and incorporate changes into the documents.
• Coordinate the review process for project and quality documents, ensuring thorough feedback is obtained.
• Address reviewer comments and incorporate changes into the documents.
• Coordinate with project manager(s) to align documentation timelines with project milestones.

Supplemental Data

• Demonstrates the behaviours of being a self-starter who is organized, detailed, conscientious, and ambitious. Leads by example.
• A team player with a positive attitude
• Performs documentation requirements in a cGMP compliant manner in accordance with Quality Policies.
• Effectively communicates within team and interfaces with other site departments, verbally and written.
• Can formulate cohesive documents from outlines or mind maps.
• Flexible working hours based on needs of the project.

Experience

• AS in Technical Writing, English or Communications with 2 years of technical writing/documentation specialist or similar role
• BS Technical Writing, English or Communications with <2years of technical writing/documentation specialist or similar role

Knowledge, Skills, and Abilities

• Technical Proficiency and Understanding: Ability to understand complex technical concepts and translate them into user-friendly language. This includes familiarity with the technology, or products being documented.
• Documentation Tools Mastery: Proficiency in documentation tools and software, such as Microsoft Office to create, format, and manage documents.
• Excellent Writing and Grammar: Strong command of the language with an ability to write clear, concise, and grammatically correct documents. This includes the ability to tailor content to different audiences.
• Research and Analysis: Skills in researching and analyzing technical information from various sources to ensure accuracy and completeness of the documentation.
• Information Design and Structuring: Ability to design and structure information in a logical, user-friendly manner, making complex information accessible and understandable.
• Attention to Detail: Meticulous attention to detail to ensure accuracy and consistency in documentation, which is crucial for the integrity of SOPs and technical documents.
• Time Management and Organization: Strong organizational and time-management skills to handle multiple projects and deadlines effectively.
• Adaptability and Learning Agility: Capacity to quickly learn new technologies and adapt to changes in tools, processes, and project requirements.