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Technical Writer - Scientific

Company: Kelly Scientific Resources
Location: Newark
Posted on: January 11, 2021

Job Description:

Title: Technical Writer Location: Newark, CA Position Summary:* The individual in this position is responsible for performing day-to-day quality assurance (QA) activities, assisting QA management with--QA processes such as: * document management* internal audits* instrumentation change control* corrective and preventative actions* assay validation planning to ensure compliance to GCLP requirements* Provide--QA support for clinical trial assay activities, including receipt, accessioning, and internal tracking of clinical trial biospecimens.Key Responsibilities:* Maintain, troubleshoot, and monitor the effectiveness of a Quality Management System (QMS)* Ensure that activities conform with the requirements of the laboratory QMS* Coordinate creation, approval, implementation, and periodic reviews of Policies and Standard Operating Procedures for the Laboratory according to GCLP guidelines* Knowledge of GXP.* Review and approve new assay validation plans and report according to GCLP guidelines with reference to CAP/CLIA.* Draft, review and approve continuing quality improvement documentation* Maintain laboratory QMS documentation in the document management system* Conduct annual QA audits of the Laboratory & clinical trial assay processes, document findings, compose and execute Corrective and Preventative Action Plans as appropriateEducation and Experience:* BS in a science related field.* At least 5 years'--experience working in a laboratory setting that included a QMS* Good working knowledge of GCP/GCLP/GXP guidelines* Understanding of ALCOLA++ and GDPR* Experience--with--Quality--Management--Systems--(e.g.,--documentation--and--record--management, change--control,--deviations,--investigations,--training--and--CAPA--programs), as well as standard digital tools* Experience--reviewing--and--auditing--study related documentation (e.g., nonclinical and clinical study reports, sponsor queries)Why Kelly--?Kelly-- Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

Keywords: Kelly Scientific Resources, Newark , Technical Writer - Scientific, IT / Software / Systems , Newark, California

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