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Junior QA & Compliance Auditor – Life Sciences

TransPerfect · Province de Buenos Aires

New
Junior 🇬🇧 English
ISO 9001 ISO 17100 GxP CAPA change control deviation management ICH E6 21 CFR Part 11 Lean Six Sigma

Job description

About the role

We are seeking a Junior Quality Assurance & Compliance Auditor to support our Global Quality Management System, ensure regulatory and industry standards compliance, and drive continuous improvement across our operations.

Key responsibilities

  • Conduct and support internal, customer, supplier, and regulatory audits.
  • Coordinate customer audits, manage audit findings, and ensure timely resolution.
  • Investigate root causes and oversee Corrective and Preventive Actions (CAPA).
  • Support the development and continuous improvement of QA programs, policies, and procedures.
  • Analyze audit data, prepare trend reports, and collaborate with internal teams and external stakeholders.
  • Help maintain compliance with ISO 9001, ISO 17100, GxP and other applicable regulations and international standards.

Required profile

  • Bachelor’s degree or equivalent.
  • At least 2 years of experience in the Life Sciences industry with QA‑related audits, clinical study documentation, and eClinical technologies.
  • Excellent written and verbal communication skills in English.
  • Strong analytical, organizational, problem‑solving and communication abilities, with the capacity to manage multiple priorities.

Required skills

  • Experience with ISO 9001, ISO 17100 and GxP standards.
  • Proficiency in CAPA, change control, deviation management and regulatory compliance.
  • Knowledge of ICH E6, 21 CFR Part 11 and related quality frameworks.
  • Familiarity with Lean, Six Sigma or other quality improvement methodologies.

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Published 2 days ago

Expires 1 month from now

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TransPerfect

Province de Buenos Aires