Senior QA Specialist
New
E
EDETEKClinical Research
Argentina. Brazil. Costa Rica. Colombia. Chile. PeruFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum of 5 years of QA experience
- Required Skills
- QAMicrosoft Office
Requirements
- Minimum 5 years of QA experience in clinical research, clinical systems, or regulated software environments.
- Bachelor’s degree in life sciences, computer science, or a related field.
- Strong knowledge of GxP, ICH-GCP, 21 CFR Part 11, Annex 11, and SDLC principles.
- Proven experience in conducting audits and managing CAPAs.
- Ability to communicate effectively in English (spoken and written).
- Proficiency with Microsoft Office applications.
- Ability to work independently, take initiative, and meet deadlines.
- Experience in a company offering eClinical or biometric services (preferred).
- Familiarity with electronic QMS platforms such as ZenQMS (preferred).
Responsibilities
- Conduct and host internal and vendor audits.
- Review and audit Trial Master File (TMF) for accuracy and compliance.
- Manage deviations, non-conformances, and CAPA processes through resolution.
- Develop and maintain SOPs, policies, and QMS documentation.
- Participate in computer system validation planning and protocol review (IQ/OQ/PQ).
- Ensure systems comply with 21 CFR Part 11, including audit trails and security.
- Monitor training curricula and track compliance.
- Act as a QA liaison across Biometrics, Software Development, and IT departments.
- Lead inspection readiness for regulatory audits like FDA or EMA.
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