TransPerfect / Software
QA & Compliance Auditor Jr (Life Sciences) - BA
nuevaDesde Argentina
- Buenos Aires, Argentina
- Tiempo completo
- Presencial
- Junior
- 2+ años de experiencia
Requisitos
- qa
- legal
- comunicación
- • 2+ años de experiencia
- • inglés
La búsqueda
We’re looking for a Quality Assurance Auditor to support our Global Quality Management System (QMS), ensure regulatory and industry standards compliance, and drive continuous improvement across our operations.
In order to apply, please submit your CV in English.
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 applicable regulations and international standards, including ISO 9001, ISO 17100, and GxP.
Requirements
Bachelor’s degree or equivalent. Excellent written and verbal communication skills in English. At least 2 years of experience in the Life Sciences industry, including QA-related audits, clinical study documentation, and eClinical technologies. Experience with Quality Assurance, CAPA, change control, deviation management, and regulatory compliance. Knowledge of relevant ISO standards and experience with internal, sponsor, or regulatory audits. Strong analytical, organizational, problem-solving, and communication skills, with the ability to manage multiple priorities.
Nice to Have
Lead Auditor certification (e.g., ISO 9001 or ISO 27001). Experience in regulated industries such as pharmaceuticals, healthcare, CROs, or medical devices. Knowledge of GxP, ICH E6, and 21 CFR Part 11. Familiarity with Lean, Six Sigma, or other quality improvement methodologies. Fluency in an additional language.
#Hiring #QualityAssurance #Auditor #LifeSciences #Compliance #TransPerfect
Publicado en LinkedIn · índice Fantastic.jobs. Los datos de requisitos los extrae Maru del aviso: ante cualquier duda, manda el aviso original.