Synectics Inc.
Technical Writer
Synectics Inc., Seattle, Washington, us, 98127
Responsibilities
Seeking a highly skilled and detail-oriented Technical Writer to join our dynamic clinical laboratory team and be responsible for creating, reviewing, and maintaining comprehensive and accurate documentation related to configuration specifications, impact assessments and clinical lab deviations.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.
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.
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).Requires a strong understanding of laboratory practices, regulatory requirements, and the ability to communicate complex information clearly and concisely.Skills:
Technical WritingAnalytical and Problem-SolvingDocumentation ManagementImpact AssessmentRegulatory Compliance
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.Benefits
Healthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics. Premiums are subsidized by Synectics.Dental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.Vision Insurance:
Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.401(k) Plan:
The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.Technical Certification Bonus:
Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.Synectics is an equal opportunity employer.
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Seeking a highly skilled and detail-oriented Technical Writer to join our dynamic clinical laboratory team and be responsible for creating, reviewing, and maintaining comprehensive and accurate documentation related to configuration specifications, impact assessments and clinical lab deviations.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.
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.
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).Requires a strong understanding of laboratory practices, regulatory requirements, and the ability to communicate complex information clearly and concisely.Skills:
Technical WritingAnalytical and Problem-SolvingDocumentation ManagementImpact AssessmentRegulatory Compliance
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.Benefits
Healthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics. Premiums are subsidized by Synectics.Dental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.Vision Insurance:
Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.401(k) Plan:
The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.Technical Certification Bonus:
Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.Synectics is an equal opportunity employer.
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