Global Quality Auditor: Drive ISO Compliance & Improvements

TransPerfect Inc; Buenos Aires; Híbrido; ARS 90.547.000 - 135.820.000; Jornada completa

Descripción de la vacante

TransPerfect Inc. seeks a Quality Assurance Auditor to oversee the company’s QMS, ensuring compliance with ISO 9001, ISO 17100, ISO 27001, and regulatory requirements.

The role drives audit programs, host client audits, investigate findings, and lead corrective actions across global operations. Ideal candidates bring at least 2 years in Life Sciences QA, strong English communication, and proficiency in CAPA, change control, and regulatory compliance, with MS Office expertise.

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.
• Overseeing sponsor audits, internal and/or regulatory inspections.
• Experience in QA, CAPA, change control, deviation management, complaint handling, and regulatory compliance.
• Minimum 2 years in Life Sciences with QA audits, clinical study documentation, and eClinical technologies.
• Proficient in Microsoft Office suite.

Responsabilidades

• Participate in development and execution of audit programs and schedules.
• Perform audits in compliance with ISO 9001, ISO 17100, GxP and related standards.
• Host, manage and coordinate customer audits and qualification activities.
• Coordinate preparation for and hosting of customer audits and allocation of internal resources.
• Manage and resolve audit findings and action items within set timeframes.
• Build relationships with client auditors and internal stakeholders.
• Assist with RFI/RFP coordination as needed.
• Conduct and support calls with customer auditors and QA representatives.
• Co-host registrar and regulatory inspections or assist in closures.
• Conduct internal and ad-hoc QA audits as needed.
• Assist QA Management in internal QA programs to maintain accreditation.
• Investigate audit findings to identify root causes and implement CAPA.
• Review CAPA effectiveness from audits.
• Utilize auditing platforms to analyze findings and maintain trackers.
• Prepare periodic trend analysis reports for management.

Conocimientos

English proficiency

Bachelor degree

ISO 9001

ISO 17100

ISO 27001

QA audits

CAPA & deviation

Life Sciences

MS Office

Educación

Bachelor's degree or equivalent

Descripción del empleo

TransPerfect Inc. seeks a Quality Assurance Auditor to oversee the company’s QMS, ensuring compliance with ISO 9001, ISO 17100, ISO 27001, and regulatory requirements.

The role drives audit programs, host client audits, investigate findings, and lead corrective actions across global operations. Ideal candidates bring at least 2 years in Life Sciences QA, strong English communication, and proficiency in CAPA, change control, and regulatory compliance, with MS Office expertise.