Title: Technical Writer
Location: Bothell, WA - 98021
Duration: 12 Months
Pay Rate: $25.00 to $28/Hourly (Only on W2 hourly)
Schedule: M-F, Normal business hours, 100% Onsite
Top Skills:
- 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.
Job Description:
- We are seeking a highly skilled and detail-oriented Technical Writer to join our dynamic clinical laboratory team.
- 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.
Key Responsibilities:
1. Documentation Development:
- 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.
2. Deviation Management:
- 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.
3. Impact Assessment:
- 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.
4. Regulatory Compliance:
- 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.
5. Training and Support:
- 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.
6. Continuous Improvement:
- 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.
Qualifications:
- 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).
Preferred Qualifications:
- 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.
