TSR Consulting
Technical Writer
TSR Consulting, Bothell, Washington, United States, 98021
About TSR:
TSR is a relationship-based, customer-focused IT and technical services staffing company.
For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.
Mission & Vision
We do not believe in building a vision around the company but building a company around our vision, which is simply;
Every employee's voice matters, their effort is appreciated, and their talent is rewarded.
We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.
Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.
Technical Writer
Job Description
Location: Bothell, WashingtonType: ContractJob #80305
Our client, a leading pharmaceutical company, is hiring a
Technical Writer,
on a contract basis.
Job ID #: 80305
Work Location:Bothell, WA - 100% onsite
Summary: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.
Education/Experience:Bachelors 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.Responsibilities: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.
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.
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.
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.
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.
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.Pay Range: $26-$28/hr
TSR is a relationship-based, customer-focused IT and technical services staffing company.
For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.
Mission & Vision
We do not believe in building a vision around the company but building a company around our vision, which is simply;
Every employee's voice matters, their effort is appreciated, and their talent is rewarded.
We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.
Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.
Technical Writer
Job Description
Location: Bothell, WashingtonType: ContractJob #80305
Our client, a leading pharmaceutical company, is hiring a
Technical Writer,
on a contract basis.
Job ID #: 80305
Work Location:Bothell, WA - 100% onsite
Summary: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.
Education/Experience:Bachelors 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.Responsibilities: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.
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.
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.
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.
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.
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.Pay Range: $26-$28/hr