Technical Writer
2 weeks ago
We are seeking a highly skilled Technical Writer to join our dynamic clinical laboratory team at Eclaro. 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.
Key Responsibilities:- Develop 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.
- Collaborate with laboratory staff, quality assurance, and regulatory affairs teams to document and assess deviations in laboratory processes and results.
- Conduct thorough impact assessments for deviations reported, ensuring that risk is evaluated and documented effectively.
- Stay up to date with industry regulations and best practices regarding clinical laboratory operations and ensure all documented processes comply with regulatory requirements.
- 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.
- 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.
Eclaro offers a competitive benefits package, including 401k Retirement Savings Plan, Commuter Check Pretax Commuter Benefits, and eligibility to purchase Medical, Dental & Vision Insurance. If you are a motivated and detail-oriented Technical Writer looking for a new challenge, please submit your resume for consideration.
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