GCP Auditor - 30179
- Location
- IL-Abbott Park, IL · On-site
- Job type
- Full-time
- Level
- Senior
- Experience
- 2+ years
- Education
- Bachelor's degree
- Listed
- Today
Skills & highlights for this role
- Quality assurance experience
- QA auditing experience
- Knowledge of FDA regulations and 21 CFR
- Knowledge of ICH guidelines
- Good writing and communication skills
- Pharmaceutical industry auditing experience
Also useful
- GCP auditing experience
- Familiarity with pending FDA regulations
- Clinical research organization experience
About the role
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 & Requirements
- 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.
From OLSA Resources, Inc.'s careers page, first listed on Rolev.ai on November 12, 2026. Rolev.ai is not the employer.
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Common questions
Where is the GCP Auditor - 30179 job at OLSA Resources, Inc. located?
This GCP Auditor - 30179 position at OLSA Resources, Inc. is located in IL-Abbott Park, IL (On-site). Always check OLSA Resources, Inc.'s application page for specific state eligibility or relocation policies.
What qualifications are required for GCP Auditor - 30179 at OLSA Resources, Inc.?
For the GCP Auditor - 30179 role, OLSA Resources, Inc. highlights 2+ years of relevant experience; a bachelor's degree; experience with Quality assurance experience, QA auditing experience, Knowledge of FDA regulations and 21 CFR, Knowledge of ICH guidelines, Good writing and communication skills, Pharmaceutical industry auditing experience. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the GCP Auditor - 30179 position at OLSA Resources, Inc.?
This listing links directly to OLSA Resources, Inc.'s SmartRecruiters application page. You can apply directly on OLSA Resources, Inc.'s site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the SmartRecruiters application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.