Junior QA & Compliance Auditor – Life Sciences
TransPerfect · Province de Buenos Aires
Descripcion del puesto
About the role
We are seeking a Junior Quality Assurance & Compliance Auditor to support our Global Quality Management System, ensure regulatory and industry standards compliance, and drive continuous improvement across our operations.
Key responsibilities
- Conduct and support internal, customer, supplier, and regulatory audits.
- Coordinate customer audits, manage audit findings, and ensure timely resolution.
- Investigate root causes and oversee Corrective and Preventive Actions (CAPA).
- Support the development and continuous improvement of QA programs, policies, and procedures.
- Analyze audit data, prepare trend reports, and collaborate with internal teams and external stakeholders.
- Help maintain compliance with ISO 9001, ISO 17100, GxP and other applicable regulations and international standards.
Required profile
- Bachelor’s degree or equivalent.
- At least 2 years of experience in the Life Sciences industry with QA‑related audits, clinical study documentation, and eClinical technologies.
- Excellent written and verbal communication skills in English.
- Strong analytical, organizational, problem‑solving and communication abilities, with the capacity to manage multiple priorities.
Required skills
- Experience with ISO 9001, ISO 17100 and GxP standards.
- Proficiency in CAPA, change control, deviation management and regulatory compliance.
- Knowledge of ICH E6, 21 CFR Part 11 and related quality frameworks.
- Familiarity with Lean, Six Sigma or other quality improvement methodologies.
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Publicado hace 2 días
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TransPerfect
Province de Buenos Aires
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