Technical Writer

$54,080 - $60,320/Yr

Sunrise Systems - Seattle, WA

Full-time - Entry Level

Seattle, WA

Professional, Scientific, and Technical Services

About the position

We are seeking a highly skilled and detail-oriented Technical Writer to join our dynamic clinical laboratory team in Seattle, WA. This is an onsite role for a contract position lasting 12 months, with the possibility of extension. The ideal candidate will be responsible for creating, reviewing, and maintaining comprehensive and accurate documentation related to configuration specifications, impact assessments, and clinical lab deviations. This role requires a strong understanding of laboratory practices, regulatory requirements, and the ability to communicate complex information clearly and concisely. The Technical Writer will work closely with laboratory staff, quality assurance, and regulatory affairs teams to ensure that all documentation meets industry standards and regulatory compliance. The Technical Writer will engage in various key responsibilities, including documentation development, deviation management, impact assessment, regulatory compliance, training and support, and continuous improvement initiatives. This position demands excellent written and verbal communication skills, strong analytical abilities, and meticulous attention to detail. The successful candidate will also be proficient in technical writing tools and software, such as the Microsoft Office Suite, and will have a solid background in a clinical laboratory or regulated environment.

Responsibilities

• Write, edit, and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs), and guidelines related to clinical lab deviations and impact assessments.
• Prepare deviation reports, impact assessment documents, and corrective and preventive action (CAPA) plans in accordance with regulatory standards and company policies.
• Collaborate with laboratory staff, quality assurance, and regulatory affairs teams to document and assess deviations in laboratory processes and results.
• Analyze data related to deviations and their impacts, ensuring all relevant information is captured for reviews and audits.
• Conduct thorough impact assessments for deviations reported, ensuring that risk is evaluated and documented effectively.
• Facilitate cross-functional meetings to gather insights from relevant stakeholders when assessing the impacts of laboratory deviations.
• Stay up to date with industry regulations and best practices regarding clinical laboratory operations and ensure all documented processes comply with regulatory requirements.
• Participate in internal audits and inspections, providing necessary documentation and supporting information as needed.
• Collaborate with training departments to develop training materials and conduct training sessions related to deviation reporting and impact assessment processes.
• Provide support and guidance to laboratory personnel regarding documentation requirements and processes.
• Assist in process improvement initiatives by identifying documentation gaps and recommending enhancements to existing processes.
• Monitor trends in deviations and impact assessments to propose strategies for mitigation and risk reduction.

Requirements

• Bachelor's degree in a relevant scientific field (e.g., Biology, Chemistry, Life Sciences) or equivalent combination of education and experience preferred.
• Proven experience as a technical writer or in a related role within a clinical laboratory or regulated environment.
• Familiarity with regulatory guidelines (e.g., CLIA, CAP, ISO) and quality management systems.
• Excellent written and verbal communication skills; ability to convey complex information clearly and concisely.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Proficiency in technical writing tools and software (e.g., Microsoft Office Suite, other documentation tools).

Nice-to-haves

• Experience in performing root cause analysis and risk assessments related to laboratory deviations.
• Knowledge of laboratory information management systems (LIMS) and related software.
• Certification in technical writing or related fields.

Benefits

• Dental insurance
• Vision insurance
• ACA compliant medical coverage
• Sick time benefits as required per State regulations