Global QA Auditor Lead – ISO 9001/17100 Expert

Transperfect; Buenos Aires; On-site; ARS 900,000 - 1,800,000; Full time

Job summary

TransPerfect seeks a Quality Assurance Auditor to strengthen our Global QMS in Buenos Aires. You will develop, implement and improve QA programs, ensure ISO 9001/17100/27001 compliance, and coordinate audits with clients, suppliers and regulators.

Ideal candidates have 2+ years in Life Sciences QA, strong English communication, and proven ability to manage multiple audits in a fast-paced environment; travel domestically and internationally may be required.

Qualifications

• Excellent written and verbal communication in English.
• Bachelor’s degree or equivalent.
• Experience with ISO 9001, ISO 17100 (EN 15038) and/or ISO 27001.
• Overseeing sponsor audits, internal and regulatory inspections.
• QA experience in Life Sciences including audits and eClinical topics.
• Ability to manage multiple projects and audits in a fast-paced environment.
• Proactive, innovative, and committed to quality and continuous improvement.
• Proficiency with Microsoft Office suite.

Responsibilities

• Develop and execute audit programs and schedules.
• Perform audits in alignment with ISO standards and regulations.
• Host and coordinate customer audits and qualification activities.
• Prepare for and host customer audits with allocated internal resources.
• Manage and close audit findings with corrective actions within timelines.
• Build relationships with client auditors and internal stakeholders.
• Assist with RFI/RFP coordination as needed.
• Conduct calls with customer auditors and QA representatives.
• Support registrar and regulatory inspections and closure activities.
• Conduct internal and ad-hoc QA audits as required.
• Support QA supplier qualification activities.
• Assist QA management in creating and evaluating internal QA programs.
• Investigate audit findings and implement CAPA with corporate alignment.
• Review effectiveness of CAPA across audits.
• Utilize auditing platforms and maintain trackers.
• Prepare trend analysis reports for management reviews.
• Collaborate with project teams to resolve audit findings.
• Contribute to continuous improvement and Total Quality Management (TQM).
• Stay current with regulatory standards relevant to QA in regulated industries.
• Travel domestically and internationally as required.

Skills

English communication

QA experience

CAPA

Change control

Deviation management

Regulatory compliance

Microsoft Office

Education

Bachelor's degree in Life Sciences or related field

Tools

ISO 9001

ISO 17100

ISO 27001

GxP

Job description

TransPerfect seeks a Quality Assurance Auditor to strengthen our Global QMS in Buenos Aires. You will develop, implement and improve QA programs, ensure ISO 9001/17100/27001 compliance, and coordinate audits with clients, suppliers and regulators.

Ideal candidates have 2+ years in Life Sciences QA, strong English communication, and proven ability to manage multiple audits in a fast-paced environment; travel domestically and internationally may be required.