Technical Writer
Current• Oversaw the creation of plans, reports, work instructions, and SOPs necessary for product development.• Worked with the Assay Development and Automation Development of products for use in genetic testing.• Created and Instituted Assay Development and Automation Development documentation practices for department-wide utilization.• Worked closely with SMEs and data analysts to comprehend workflows and time requirements for verification and validation documentation.• Collaborated with project and department managers to establish precise documentation timelines.• Trained R&D personnel on the new EDMS system (Veeva) and created detailed instructions for system operation.• Enhanced the Clinical Validations document workflow by introducing new document summary templates and gaining the support of other departments.• Developed training modules for QA and Validation staff to increase understanding of data traceability and file creation, interpretation, and storage.• Participated in new test development and validation efforts by collaborating with R&D teams.• Contributed to documentation process design and implementation.• Created and maintained templates, work instructions, and SOPs.• Provided training and support for template users and document owners.• Ensured regulatory compliance by maintaining consistent language and style when reviewing data and assisting with documentation.