QA Audit & Compliance Specialist (Life Sciences)

TransPerfect; Buenos Aires; Presencial; ARS 900.000 - 1.300.000; Jornada completa

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

At TransPerfect we are 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 conduct and support internal, customer, supplier, regulatory, and certification audits while ensuring compliance with applicable regulations and international standards, including ISO 9001 and ISO 17100. You will work closely with clients, auditors, vendors, and internal stakeholders to coordinate audits, address findings, and drive effective corrective and preventive actions (CAPA).

Responsibilities:

• 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 activities.
• Partner with clients, auditors, suppliers, and internal teams to ensure timely and effective audit resolution.
• Investigate audit findings and operational issues, identify root causes, and support effective CAPA implementation.
• Review the effectiveness of corrective and preventive actions resulting 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.
• Support the development, implementation, and continuous improvement of QA programs, processes, and procedures.
• Maintain audit-related systems, trackers, and documentation.
• Contribute to the ongoing enhancement of TransPerfect’s QMS and Total Quality Management (TQM) initiatives.
• Stay current with relevant regulatory and industry standards.
• Travel domestically and internationally as required.

Required:

• Bachelor’s degree or equivalent.
• Excellent written and verbal communication skills in English.
• Minimum 2 years of experience in the Life Sciences industry, including experience with QA audits, clinical study documentation, and 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 supporting or overseeing sponsor, internal, and/or regulatory audits or inspections.
• Ability to manage multiple projects and audits simultaneously in a fast-paced environment.
• Strong problem-solving, critical-thinking, and analytical skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Proficiency in Microsoft Office.

Preferred:

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

This is an opportunity to join a global QA function where you will work across teams, interact with clients and auditors, and contribute directly to quality, compliance, risk management, and continuous improvement within a global organization.