Global QA Auditor - Life Sciences Compliance & CAPA Lead

TransPerfect

Buenos Aires

Presencial

ARS 900.000 - 1.300.000

Jornada completa

Hace 5 días
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Descripción de la vacante

TransPerfect is looking for a Quality Assurance Auditor to join our QA team and strengthen our global QMS. You will conduct and support internal, customer, supplier, regulatory, and certification audits to ensure compliance with ISO standards.

You will drive CAPA, analyze audit findings, coordinate with clients and teams, and support continuous improvement across QA programs and procedures. Travel may be required.

Formación

  • Bachelor’s degree in Life Sciences or equivalent.
  • Excellent written and verbal English communication.
  • Minimum 2 years of Life Sciences QA/audit experience, incl. CAPA and documentation.
  • Experience with ISO 9001, ISO 17100, ISO 27001 or similar standards.
  • Experience supporting sponsor/internal/regulatory audits or inspections.
  • Ability to manage multiple audits in a fast-paced environment.
  • Proficient in Microsoft Office.

Responsabilidades

  • Develop and execute audit programs and schedules.
  • Coordinate and support customer, regulatory, certification, supplier, and internal audits.
  • Manage customer audit preparation, communications, findings, action items, and follow-up.
  • Partner with clients, auditors, suppliers, and internal teams to ensure timely audit resolution.
  • Investigate audit findings and identify root causes; support CAPA implementation.
  • Review the effectiveness of corrective and preventive actions from audits.
  • Conduct and support QA internal and ad-hoc audits as needed.
  • Support regulatory inspections and certification/registrar audits.
  • Assist with supplier qualification activities.
  • Analyze audit data and prepare trend analysis reports and management presentations.
  • Contribute to QA program improvements and documentation maintenance.
  • Stay current with regulatory standards and industry practices.
  • Travel domestically and internationally as required.

Conocimientos

Auditing
Quality systems
Regulatory compliance
Analytical thinking
Communication
Project management

Educación

Bachelor's degree in Life Sciences

Herramientas

MS Office
Audit management software

Descripción del empleo

TransPerfect is looking for a Quality Assurance Auditor to join our QA team and strengthen our global QMS. You will conduct and support internal, customer, supplier, regulatory, and certification audits to ensure compliance with ISO standards.

You will drive CAPA, analyze audit findings, coordinate with clients and teams, and support continuous improvement across QA programs and procedures. Travel may be required.

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