Document Control Coordinator

3 weeks ago

Seattle, United States Sunrise Systems, Inc. Full time

Job Title: Technical Writer/ Quality Document Control

Duration : 12 Months (Possibility of extension)

Location: Seattle, WA

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: Job Title: Technical Writer

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.


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 field

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