QA Auditor - Life Sciences

TransPerfect; Buenos Aires; Presencial; ARS 2.009.000 - 2.678.000; Jornada completa

Descripción de la vacante

TransPerfect is seeking a Quality Assurance Auditor to join our QA team and strengthen the Global Quality Management System. You will help ensure compliance with ISO 9001, ISO 17100, ISO 27001, GxP, and Life Sciences regulations, working with clients, auditors, and internal teams to manage audits and CAPAs.

This role requires at least 2 years in Life Sciences QA audits, strong analytical and communication skills, and the ability to travel.

Formación

• Bachelor’s degree or equivalent required.
• Minimum 2 years in Life Sciences QA audits and regulatory documentation/eClinical systems.
• Experience with QA, CAPA, change control, deviation management, and regulatory compliance.
• Knowledge of ISO 9001, ISO 17100, ISO 27001 and related standards.
• Experience with sponsor/internal/regulatory audits or inspections.

Responsabilidades

• Develop and execute audit programs and schedules.
• Conduct and support internal, customer, supplier, regulatory, and independent audits.
• Coordinate customer audits, inspections, and qualification activities.
• Manage audit findings, CAPAs, follow-ups, and remediation activities.
• Analyze audit trends and prepare reports for management review.
• Support the development and improvement of QA programs, policies, SOPs, and processes.
• Investigate findings and root causes, drive corrective and preventive actions.
• Collaborate with project teams to ensure timely audit resolution.
• Support continuous improvement and enhancement of the QMS.
• Travel domestically and internationally as required.

Conocimientos

QA audits

CAPA

Change control

Deviation management

Regulatory compliance

Analytical skills

Communication skills

Organizational skills

Microsoft Office

English fluency

Educación

Bachelor’s degree

Herramientas

Microsoft Office

Descripción del empleo

TransPerfect is looking for a Quality Assurance Auditor to join our QA team and play a key role in maintaining and continuously improving our Global Quality Management System (QMS).

In this role, you will help ensure compliance with international standards and regulatory requirements, including ISO 9001, ISO 17100, ISO 27001, GxP, and applicable Life Sciences regulations. You’ll work closely with clients, auditors, internal teams, vendors, and other stakeholders to manage audits, findings, CAPAs, and continuous improvement initiatives.

Position responsibilities:

• Develop and execute audit programs and schedules.
• Conduct and support internal, customer, supplier, regulatory, and independent audits.
• Coordinate customer audits, inspections, and qualification activities.
• Manage audit findings, CAPAs, follow-ups, and remediation activities.
• Analyze audit trends and prepare reports for management review.
• Support the development and improvement of QA programs, policies, SOPs, and processes.
• Investigate findings and operational issues, identify root causes, and drive effective corrective and preventive actions.
• Collaborate with project teams and stakeholders to ensure timely audit resolution.
• Support continuous improvement and the enhancement of the QMS.
• Travel domestically and internationally as required.
  

What We’re Looking For:

• Bachelor’s degree or equivalent.
• 2+ years of experience in the Life Sciences industry, including QA audits and clinical study documentation/eClinical technologies.
• Experience with Quality Assurance, CAPA, change control, deviation management, complaint handling, and regulatory compliance.
• Knowledge of ISO 9001, ISO 17100, ISO 27001, and/or other international standards and regulations.
• Experience with sponsor, internal, and/or regulatory audits or inspections.
• Strong analytical, problem-solving, communication, and organizational skills.
• Ability to manage multiple audits and projects in a fast-paced environment.
• Proficiency in Microsoft Office.
• Excellent written and verbal English communication skills.
  

Nice to Have:

• Lead Auditor certification.
• Experience in regulated industries such as Pharmaceuticals, CRO, Medical Devices, Healthcare, or Finance.
• Knowledge of ICH E6, 21 CFR Part 11, GxP, and clinical development processes.
• Experience with Lean, Six Sigma, or other quality methodologies.
• Fluency in an additional language.

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