What are the responsibilities and job description for the GCP Auditor position at Barrington James?
GCP Auditor
Remote
Company Description
Working for a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. They focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
- Primary communication line for project teams with regard to internal quality assurance (QA) study audits, including audits of clinical trial database
- Primary communication line for project teams with regard to follow-up on and resolution of QA study audits
- Preparation, conduct, and reporting of internal QA study audits, including audits of clinical trial database
- Communicate with Company divisions/operational offices with regard to internal systems and location audits
- Collaborate with vendors with regard to vendor qualification audits
- May be involved in the communication with Operations staff with regard to issues related to quality assurance
- Communicate with clients with regard to QA audits contracted to the company.
- Assembling internal study and clinical trial database audits documentation
- May be involved in the preparation, conduct, and reporting of internal systems audits, internal locations audits, and vendor qualification audits
- Training of Operations staff in quality management topics
Qualifications
- College or university degree required; MD, PharmD or degree in life sciences is a plus
- A minimum of 3 years in quality management or quality assurance within a GCP-regulated environment
- Experience conducting GCP investigator site audits
- Willing to travel both domestically and internationally
- Strong communication skills and ability to work both independently and within a team environment
- Detail-oriented and a dedication to upholding quality is crucial
- Intermediate proficiency in MS Office
- Should be a reasonably effective public speaker
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