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Job: SR. QA Auditor - GCP, CTI Clinical Trial Consulting, Raleigh, NC

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General Information


Job title: SR. QA Auditor - GCP
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Job location: Raleigh, NC  27615 United States
Requisition code:
Date posted: 10/03/2017
Job category:Clinical Research
Research and Development
Employment type:Full time
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Job Description

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Job Purpose/Summary: The Senior Auditor, Quality Assurance is responsible for assessment of quality and compliance according to CTI and/or Sponsor SOPs and all relevant regulations and guidelines.

Duties and Responsibilities:
• Host Sponsor audits at CTI and assist with FDA Inspections
• Assure that issues from Sponsor audits are promptly communicated to the appropriate team members,
assist with the development of a corrective action plan and facilitate resolution of all audit findings
• Assist with quality assurance training for CTI staff
• Conduct Vendor Audits, Internal System Audits, Site Audits and Computerized Systems and Database
Validation Audits. Identify and follow-up on any unresolved audit findings identified in a Quality
Assurance Audit
• Conduct Sponsor-contracted audits, such as: Clinical Study Report Audits, Clinical Protocol Audits,
Clinical Database Audits, Investigator Site Audits, etc on an ad hoc or scheduled basis as determined by
the Sponsor and CTI management
• Assist with SOP development and review
• Assist with SOP system maintenance
• Provide content and/or present quality related information at capabilities presentations
• Other duties as required
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Job Requirements

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• Minimum 5-8 years of related experience or relevant pharmaceutical and/or CRO experience in QA
• Comprehensive understanding of GCP/ICH Guidelines and relevant regulations
• Excellent verbal and written communication skills.
• Clinical quality assurance audit experience preferred but not required
• SQA, CQA or other quality related certification preferred but not required
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