Senior GCP Auditor

Senior GCP Auditor

Job Title: Senior GCP Auditor
Contract Type: Permanent
Location: New Jersey
Salary: Negotiable
Reference: AM10004
Contact Name: Amy Ma
Contact Email:
Job Published: January 23, 2017 22:31

Job Description

Position Summary:

The Senior GCP Auditor will deliver Good Clinical Practices (GCP) Quality Assurance (QA) audit program as well as support its GCP Quality Management System (QMS) to ensure compliance with federal regulations and company policies and procedures. The position plays a key role within the company's GCP QA processes and represents the company both internally and externally.

The responsibilities of this job include, but are not limited to, the following:

  • Lead qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors and other clinical vendors to assess effectiveness of QMSs and compliance to approved clinical study protocols and contracts
  • Conduct Clinical Study Report (CSR) and Trial Master Files (TMF) audits
  • Ensure timely issuance of audit reports, audit observation forms, oversee audit response process and drive audits to closure
  • Maintain and enhance procedures for communicating audit observations and tracking audit responses
  • Support preparation of Quality Management Review (QMR) meetings to support Head, GCP QA's management reporting

Education: Bachelor of Science or Bachelor of Arts degree, minimum, in a relevant scientific discipline

Computer Skills: Proficient in MS Office suite, including Visio (MS Office products, word processing, spreadsheets, internet, e-mail)

Experience: 5 Years GCP QA auditing experience in an FDA regulated industry, Pharma or Biotech preferred

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