Quality and Regulatory Affairs Auditor - BA

TransPerfect; Buenos Aires; Presencial; ARS 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

TransPerfect is seeking a QA Auditor to join our Quality Assurance team supporting the Global Quality Management System. You will conduct internal, supplier, and regulatory audits and coordinate inspections to ensure compliance with international standards.

This role requires 2+ years in Life Sciences QA, English communication, and proficiency with CAPA, change control, deviation handling, and regulatory requirements. Domestic and international travel is expected.

Formación

• Bachelor's degree or equivalent.
• Excellent written and verbal English communication skills.
• 2+ years of experience in the Life Sciences industry, with QA/audit experience.
• Experience with QA, CAPA, change control, deviation management, complaint handling, and regulatory compliance.
• Experience with internal, customer/sponsor, and/or regulatory audits.
• Knowledge of ISO 9001, ISO 17100, ISO 27001, GxP, ICH E6, and/or 21 CFR Part 11 is a plus.
• Strong analytical, problem-solving, organizational, and interpersonal skills.
• Ability to manage multiple audits and projects in a fast-paced environment.
• Proficiency in Microsoft Office.

Responsabilidades

• Plan and conduct internal, customer, supplier, and regulatory audits.
• Coordinate customer audits and inspections, including preparation, communications, and follow-up.
• Manage audit findings, CAPAs, and corrective actions through timely resolution.
• Support compliance with standards including ISO 9001, ISO 17100, ISO 27001, GxP, and other applicable regulations.
• Analyze audit data and prepare trend reports for management.
• Support the development and continuous improvement of QA programs, processes, and the QMS.
• Collaborate with clients, auditors, vendors, and internal stakeholders to ensure effective audit outcomes.
• Stay current with regulatory and industry requirements.
• Travel domestically and internationally as required.

Conocimientos

QA Auditing

CAPA

Change Control

Deviation Management

Regulatory Compliance

Internal/Regulatory Audits

Microsoft Office

English Proficiency

Educación

Bachelor's degree

Herramientas

Microsoft Office

Descripción del empleo

We are looking for a QA Auditor to join our Quality Assurance team and support the continuous improvement of our Global Quality Management System (QMS). In this role, you will conduct and coordinate audits, support regulatory and customer inspections, manage audit findings and CAPAs, and ensure compliance with applicable international standards and regulations.

Position responsibilities

• Plan and conduct internal, customer, supplier, and regulatory audits.
• Coordinate customer audits and inspections, including preparation, communications, and follow-up.
• Manage audit findings, CAPAs, and corrective actions through timely resolution.
• Support compliance with standards including ISO 9001, ISO 17100, ISO 27001, GxP, and other applicable regulations.
• Analyze audit data and prepare trend reports for management.
• Support the development and continuous improvement of QA programs, processes, and the QMS.
• Collaborate with clients, auditors, vendors, and internal stakeholders to ensure effective audit outcomes.
• Stay current with regulatory and industry requirements.
• Travel domestically and internationally as required.

Requirements

• Bachelor's degree or equivalent.
• Excellent written and verbal English communication skills.
• 2+ years of experience in the Life Sciences industry, with QA/audit experience.
• Experience with QA, CAPA, change control, deviation management, complaint handling, and regulatory compliance.
• Experience with internal, customer/sponsor, and/or regulatory audits.
• Knowledge of ISO 9001, ISO 17100, ISO 27001, GxP, ICH E6, and/or 21 CFR Part 11 is a plus.
• Strong analytical, problem-solving, organizational, and interpersonal skills.
• Ability to manage multiple audits and projects in a fast-paced environment.
• Proficiency in Microsoft Office.

Preferred

Lead Auditor certification, experience in regulated industries, Lean/Six Sigma knowledge, and fluency in an additional language.