Join TransPerfect’s Quality Assurance team and play a key role in strengthening our Integral Quality Management System (QMS), supporting customer confidence, and driving continuous improvement across the organization.

As a Quality Assurance Auditor, you will work independently and objectively across a wide range of quality and compliance activities, partnering with clients, auditors, vendors, project teams, and internal stakeholders.

In order to apply, please submit your CV in English

Position responsibilities:

- Develop and execute audit programs and schedules.
- Conduct compliance audits in accordance with applicable standards and regulations, including ISO 9001, ISO 17100, ISO 27001, GxP, and other relevant requirements.
- Host, manage, and coordinate customer/sponsor audits, qualification activities, and audit communications.
- Coordinate preparation and resources for customer audits, regulatory inspections, and registrar audits.
- Manage audit findings, CAPAs, action items, and follow-up activities through timely resolution and closure.
- Conduct and support internal, independent, supplier, and ad hoc QA audits.
- Investigate audit findings and operational issues, identify root causes, and support effective Corrective and Preventive Actions (CAPA).
- Evaluate CAPA effectiveness and support continuous improvement initiatives.
- Analyze audit data and prepare trend reports and management review materials.
- Partner with project teams to ensure timely and appropriate resolution of audit findings.
- Support the development, implementation, and continuous improvement of QA programs, policies, processes, and procedures.
- Contribute to the ongoing enhancement of TransPerfect’s QMS and Total Quality Management (TQM) initiatives.
- Maintain current knowledge of regulatory and industry standards relevant to QA and regulated industries.
- Build and maintain strong relationships with customers,



auditors, quality representatives, vendors, and internal stakeholders.
- Travel domestically and internationally, as required.

Essential skills and experience required:

- Bachelor’s degree or equivalent.
- Excellent written and verbal English communication skills.
- At least 2 years of experience in the Life Sciences industry, including QA-related audits, clinical study documentation, and/or eClinical technologies.
- Experience in Quality Assurance, CAPA, change control, deviation management, complaint handling, and regulatory compliance.
- Experience with ISO 9001, ISO 17100 (EN 15038), ISO 27001, and/or other international standards and regulations.
- Previous experience overseeing sponsor, internal, and/or regulatory inspection audits.
- Ability to manage multiple audits and projects simultaneously in a fast-paced environment.
- Strong problem-solving, critical-thinking, organizational, and analytical skills.
- A proactive, innovative, and resourceful approach, with a strong commitment to quality and continuous improvement.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Proficiency in Microsoft Office Suite.

Desired skills and experience:

- QA experience in regulated industries such as Pharmaceutical, CRO, Medical Device, Healthcare, Finance, or Investigative Site environments.
- Lead Auditor certification in relevant ISO standards.
- Knowledge of ICH E6, 21 CFR Part 11, GxP, and clinical development phases and processes.
- Experience with Six Sigma, Lean, or other quality methodologies.
- Experience training employees on QA SOPs and regulatory requirements.
- Experience hosting or supporting regulatory inspections.
- Fluency in a language other than English.

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📌 QA Auditor - BA (Life Sciences) (Buenos Aires)
🏢 Transperfect
📍 Buenos Aires