Job Title: Technical Writer Location: Bothell, WA, 98102 Schedule: M-F, Normal business hours, 100% Onsite Duration:12 months
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.
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: o Write, edit, and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs), and guidelines related to clinical lab deviations and impact assessments. o Prepare deviation reports, impact assessment documents, and corrective and preventive action (CAPA) plans in accordance with regulatory standards and company policies. 2. Deviation Management: o Collaborate with laboratory staff, quality assurance, and regulatory affairs teams to document and assess deviations in laboratory processes and results. o Analyze data related to deviations and their impacts, ensuring all relevant information is captured for reviews and audits. 3. Impact Assessment: o Conduct thorough impact assessments for deviations reported, ensuring that risk is evaluated and documented effectively. o Facilitate cross-functional meetings to gather insights from relevant stakeholders when assessing the impacts of laboratory deviations. 4. Regulatory Compliance: o Stay up to date with industry regulations and best practices regarding clinical laboratory operations and ensure all documented processes comply with regulatory requirements. o Participate in internal audits and inspections, providing necessary documentation and supporting information as needed. 5. Training and Support: o Collaborate with training departments to develop training materials and conduct training sessions related to deviation reporting and impact assessment processes. o Provide support and guidance to laboratory personnel regarding documentation requirements and processes. 6. Continuous Improvement: o Assist in process improvement initiatives by identifying documentation gaps and recommending enhancements to existing processes. o 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.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $28.00/hr.
