Quality Assurance Auditor (GCP)

Company Description

PSI is 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.  We 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 PSI 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 PSI Operations staff with regard to issues related to quality assurance
• Communicate with PSI clients with regard to QA audits contracted to PSI
• 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 PSI 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

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.