Thoughtful Science. Tailored Solutions. NERI is a full-service Contract Research Organization that provides customized, global clinical trial solutions and registry services to pharmaceutical, biotechnology, biomaterial, and medical device companies. NERI also has notable experience collaborating on federally-funded research with organizations like the National Institutes of Health. Since its founding in 1986, NERI has earned widespread recognition for its scientific credibility, efficiency, and expertise in the successful conduct of clinical trials.
We are currently looking for a full time Quality Assurance Auditor. In that position, the Quality Assurance Auditor will:
· Plan, schedule and conduct internal QA audits of clinical trials research studies;
· Evaluate the impact of the audit findings and identifies corrective or preventive actions;
· Document and communicate findings;
· Identify quality system improvements;
· In collaboration with the Director of Scientific Integrity, organize and provide staff training on Quality Policies and Quality Systems;
· Assist project staff in the development, implementation and maintenance of project-level quality systems.
Qualifications:
· Must have GCP compliance knowledge
· Documented training in GCP and QA and a familiarity with data management systems and electronic data capture;
· BS in related field;
· Minimum 3 years experience organizing and conducting internal QA audits with solid experience in quality assurance and compliance related matters.
· Evidence of understanding and monitoring of compliance with SOP's, GCP, NIGH/HHS and FDA regulations.
· Strong written and verbal communication skills, organization, analytical, problem solving and conflict resolution skills;
If interested, please send your resume and cover letter to Human Resources at humanresources@neriscience.com or visit us at www.neriscience.com
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NERI is an Equal Opportunity/Affirmative Action Employer M/F/D/V