GCP Auditor - 30179

Job Description

Auditing, document review, and project services within a Quality Assurance environment. May assist team during report audits and internal audits according to FDA Good Clinical Practices Regulations, ICH Guidelines and PPGs. May assist team with QC services of Audit Files, spreadsheets, audit reports, as well as assigned projects.

Familiarity with current and pending FDA regulations, 21 CFR and ICH guidelines. Render training presentations on regulations, compliance and quality related subjects as requested. Maintain liaison with all appropriate inter-divisional and intra company departments and teams to ensure expeditious compilation of projects and corrective action for audit observations.
Responsible for assessing quality systems/scientific reports and clinical data; conducting internal and external audits of clinical investigator sites, contract research organizations and vendors. Will generate audit reports and render quality assurance presentations to organization's  affiliates, clinical investigators and R&D personnel.

Qualifications

2-5 years Quality Assurance or experience within a clinical research organization. 1-2 years QA auditing experience, GCP auditing experience is preferred. Bachelor's Degree in a physical or life science, nursing or pharmacy.

Good writing and communication skills and auditing experience in the pharmacuetical industry required.

Additional Information