Global QA Auditor: ISO 9001/17100 Compliance & CAPA

BairesDev; Quilmes; Hybrid; ARS 600,000 - 900,000; Full time

Job summary

TransPerfect is seeking a Quality Assurance Auditor to strengthen its Global QMS, ensuring compliance with ISO 9001, ISO 17100, and other regulatory frameworks. The role involves auditing programs, managing customer audits, and driving CAPA initiatives within the Life Sciences sector.

Applicants should have a bachelor’s degree and at least two years of QA auditing experience in life sciences, with strong English communication and collaborative skills for cross-functional teams.

Qualifications

• Excellent written and verbal communication in English.
• Experience with ISO 9001, ISO 17100 and/or ISO 27001.
• Minimum of two years in Life Sciences QA audits.

Responsibilities

• Participate in development and execution of audit programs and schedules.
• Perform audits in compliance with ISO 9001, ISO 17100, GxP and other standards.
• Host, manage and coordinate customer audits and qualification activities.
• Coordinate preparation for hosting 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 QA internal and external audits and support regulatory inspections.
• Maintain QA programs to support accreditation and certification.
• Investigate audit findings to identify root causes and implement CAPA.

Skills

QA auditing

English communication

CAPA

Regulatory compliance

Life Sciences

Quality Assurance

ISO 9001

ISO 17100

Education

Bachelor’s degree

Job description

TransPerfect is seeking a Quality Assurance Auditor to strengthen its Global QMS, ensuring compliance with ISO 9001, ISO 17100, and other regulatory frameworks. The role involves auditing programs, managing customer audits, and driving CAPA initiatives within the Life Sciences sector.

Applicants should have a bachelor’s degree and at least two years of QA auditing experience in life sciences, with strong English communication and collaborative skills for cross-functional teams.