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Quality Assurance Auditor -GLP Lincoln United States,  


Posted on : 09 April 2017

Project Description

Celerion, a leading global contract research organization, seeks a Quality Assurance Auditor to support our Bioanalytical department.  The successful candidate will have quality assurance expertise within a GLP environment.  This role is located at our Lincoln, NE facility.  Role:  The role of the Quality Assurance Auditor is to assess and assure study, project and process compliance with protocols, Controlled documents, and applicable regulations and guidelines through audits.    Responsibilities:   Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections. Perform in-process inspections of study phases and methods; report audit findings to operations via QA audit reports; determine acceptability of the responses and verify the corrections. Review study events, deviations, investigations, and change control documentation; and assess acceptability of the content and documentation. Maintain QA files and QA audit reports. Interact with internal and external clients to discuss QA observations and study related issues; and maintain effective and professional working relationships within and across departments in relation to study projects. Perform other functions as assigned by Quality Assurance Management. Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes. Detect Quality Issues and the need for CAPAs and assist Quality Assurance Management with the QI/CAPA  process Assist with the preparation for and hosting of client audits and/or regulatory inspections. Participate in the preparation, execution and follow up for System Audits and Vendor Audits.   Education and Qualifications:   Bachelor’s degree in science, IT, business, or similar 2-5 years quality/ functional ops/ GLP experience Working knowledge of applicable regulations and guidance documents (GLP/GCP/E-records & E-signatures) Excellent oral and written communication skills Ability to organize and manage multiple priorities Excellent time management skills Attention to detail, tactful, and diplomatic Proficiency with Microsoft Office and general computer knowledge   About Celerion: In addition to providing clinical pharmacology and early clinical research services in North America and Europe, Celerion operates two bioanalytical laboratories where the latest analytical technologies are leveraged to provide quantitative measures of drug, metabolite and biomarkers in samples collected from humans participating in research studies.  With over 750 employees and over 40 years of experience conducting early clinical research, Celerion is the provider of choice for many of the world’s leading pharmaceutical companies.  In addition, Celerion scientists bring a depth of experience in drug development that is proving important for growing businesses in Asia and other parts of the world.   EEO/AA M/F/Vet/Disability  

Locations

Lincoln Nebraska

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