QA Clinical Auditor II

This is a fully remote position, open to applicants in Brazil, +2 more countries.

📋 Description

• Conduct and/or lead audits for clients, internal teams, GCP, sites, facilities, vendors, and subcontractors.

• Engage in regulatory inspections as needed by senior management.

• Offer GCP consultation and support to project teams and external clients.

• Oversee process audits and participate in complex system audits.

• Execute QA activities including database audits, clinical study report audits, sample results tables, and process enhancements.

• Act as a QA and audit subject-matter expert for operational departments.

• Prepare and present audit results and related information during departmental, operational, and client meetings.

• Work in office, laboratory, and/or clinical settings.

• Utilize required personal protective equipment and manage potential exposure to biological fluids and infectious organisms.

⛳️ Requirements

• Bachelor's degree or equivalent relevant formal academic/vocational training.

• A minimum of 2 years of prior QA experience.

• In-depth knowledge of GCP and relevant regional research regulations and guidelines.

• Proven expertise in project-based or internal GCP audits and vendor audits.

• Exceptional oral and written communication skills.

• Strong abilities in problem-solving, risk assessment, and impact analysis.

• Experience with root cause analysis.

• Skills in negotiation and conflict management.

• Capacity to multitask and prioritize conflicting demands/workload.

• A valid driver's license.

• Capability to qualify for and maintain a corporate credit card with an adequate credit limit for business travel.

• Ability to work in an upright and/or stationary position for 6–8 hours daily.

• Competence in frequent mobility, bending, twisting, crouching, and stooping.

• Ability to lift and carry weights of 15–20 lbs.

• Proficient in accessing and using computer software.

• Regular and consistent attendance is required.

🏝️ Benefits

• A global team environment.

• Opportunities for collaboration and professional development.

• A commitment to scientific excellence.