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Quality Assurance Auditor -GLP - United States  

Celerion (company)


Posted on : 09 April 2017

Project Description

Our company is 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.  

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. 

  • 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 us:
  •  In addition to providing clinical pharmacology and early clinical research services in North America and Europe, our company operates two bio-analytical 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, our company  is the provider of choice for many of the world’s leading pharmaceutical companies.  
  • In addition, our company scientists bring a depth of experience in drug development that is proving important for growing businesses in Asia and other parts of the world.