Ihire - Bothell, WA
posted 3 months ago
As a Technical Writer at Innova Solutions, you will play a crucial role in ensuring that laboratory practices and regulatory requirements are clearly documented and communicated. This position requires a strong understanding of laboratory operations, regulatory standards, and the ability to convey complex information in a clear and concise manner. You will be responsible for writing, editing, and maintaining Standard Operating Procedures (SOPs), Work Instructions (WIs), and guidelines that are essential for compliance and operational efficiency. Your responsibilities will include preparing deviation reports, impact assessment documents, and corrective and preventive action (CAPA) plans in accordance with regulatory standards and company policies. You will collaborate closely with laboratory staff, quality assurance, and regulatory affairs teams to document and assess deviations in laboratory processes and results. Analyzing data related to deviations and their impacts will be a key part of your role, ensuring that all relevant information is captured for reviews and audits. In addition, you will conduct thorough impact assessments for reported deviations, ensuring that risks are evaluated and documented effectively. Facilitating cross-functional meetings to gather insights from relevant stakeholders will be essential when assessing the impacts of laboratory deviations. Staying up to date with industry regulations and best practices regarding clinical laboratory operations will be necessary to ensure that all documented processes comply with regulatory requirements. You will also participate in internal audits and inspections, providing necessary documentation and supporting information as needed. Collaborating with training departments to develop training materials and conduct training sessions related to deviation reporting and impact assessment processes will be part of your responsibilities. Furthermore, you will provide support and guidance to laboratory personnel regarding documentation requirements and processes, assisting in process improvement initiatives by identifying documentation gaps and recommending enhancements to existing processes. Monitoring trends in deviations and impact assessments will allow you to propose strategies for mitigation and risk reduction.