GCP Auditor - 30179

OLSA Resources, Inc.; United States; On-site; USD 60,000 - 80,000; Full time

Job summary

A Quality Assurance Consulting Firm based in the United States is looking for a dedicated Quality Assurance professional. The ideal candidate will have 2-5 years of related experience, especially in QA auditing within the pharmaceutical industry. Responsibilities include conducting internal and external audits, generating reports, and working closely with various teams. Strong communication and writing skills are critical for this role. This position offers opportunities for professional development in a regulatory environment.

Qualifications

• 2-5 years in Quality Assurance or clinical research organization.
• 1-2 years QA auditing experience, GCP auditing preferred.
• Experience in the pharmaceutical industry required.

Responsibilities

• Conduct internal and external audits of clinical sites and vendors.
• Generate audit reports and quality assurance presentations.
• Assist team during report audits and maintain liaisons with departments.

Skills

Writing skills

Communication skills

Auditing experience

Education

Bachelor's Degree in physical or life science, nursing or pharmacy

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.