Global QA Auditor: ISO & Regulatory Compliance

TransPerfect; Buenos Aires; Presencial; ARS 1.000.000 - 1.500.000; Jornada completa

Descripción de la vacante

TransPerfect is seeking a Quality Assurance Auditor in Argentina to independently strengthen our Global Quality Management System. You will drive audits, ensure compliance with ISO 9001, ISO 17100, GxP, and related regulations, and collaborate with clients, vendors, and internal teams to drive CAPA and continuous improvement.

In this role, you will develop audit programs, host customer audits, manage findings and action items, and contribute to internal QA programs while staying current with

Formación

• Excellent written and verbal communication in English.
• Bachelor’s degree or equivalent.
• Experience with ISO 9001, ISO 17100 (EN 15038) and/or ISO 27001 and/or other international standards and regulations.
• Experience overseeing sponsor audits, internal, and/or regulatory inspection audits.
• Experience in Quality Assurance, CAPA, change control, deviation management, complaint handling, and regulatory compliance.
• Minimum of two (2) years in Life Sciences QA audits, clinical study documentation, and eClinical technologies.
• Ability to manage multiple projects and audits in a fast-paced environment.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office suite.

Responsabilidades

• Develop and execute audit programs and schedules.
• Perform audits complying with ISO 9001, ISO 17100, GxP, etc.
• Host and coordinate customer audits and qualification activities.
• Coordinate preparation for customer audits and allocate internal resources.
• Manage and resolve audit findings and follow-up actions.
• Build relationships with client auditors and internal stakeholders.
• Assist with RFI/RFP coordination as needed.
• Conduct and support QA audits and regulatory inspections.
• Maintain audit platforms and internal trackers.
• Prepare and present trend analyses to management.
• Support management reviews with QA data.

Conocimientos

Audit management

Quality Assurance

Regulatory compliance

CAPA

GxP

ISO 9001

ISO 17100

Life Sciences

Project management

Microsoft Office

English proficiency

Educación

Bachelor’s degree or equivalent

Herramientas

MS Office

Descripción del empleo

TransPerfect is seeking a Quality Assurance Auditor in Argentina to independently strengthen our Global Quality Management System. You will drive audits, ensure compliance with ISO 9001, ISO 17100, GxP, and related regulations, and collaborate with clients, vendors, and internal teams to drive CAPA and continuous improvement.

In this role, you will develop audit programs, host customer audits, manage findings and action items, and contribute to internal QA programs while staying current with