Specialist, Quality Assurance
New
C
Care AccessClinical Research
Brazil-Home OfficeFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Portuguese and English required, Spanish is a plus.
- Experience
- 2 years of experience in Quality Assurance, 4 years of experience in Clinical Research working in a compliance or GCP relevant role.
- Required Skills
- GCPQuality Assurance
Requirements
- Bachelor's degree.
- 2 years of experience in Quality Assurance.
- 4 years of experience in clinical research working in a compliance or GCP relevant role.
- Fluency in both Portuguese and English.
- Knowledge of GxP guidelines, 21 CFR Part 11/Part 312, and ICH GCP E6 (R3).
- Experience with internal and external audits (FDA, GCP, SOPs).
- Strong organizational, writing, and presentation skills.
- Technical proficiency in QMS and various business software platforms.
- Ability to work independently and manage multiple assignments.
- Ability to communicate and work effectively with diverse teams.
Responsibilities
- Ensure site-level quality and data integrity via regular reviews and SOP compliance checks.
- Conduct reviews of regulatory binders and clinical documents to verify GCP standards.
- Execute the yearly corporate audit plan and prepare detailed outcome reports.
- Manage CAPA plans in partnership with research staff and Principal Investigators.
- Provide operational support for external audits and regulatory inspections.
- Maintain quality systems, compliance trackers, and operational programs.
- Participate in the review and maintenance of SOPs.
- Act as an internal resource for compliance guidance and project teams.
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