Senior QA Lead — Remote | GxP & Compliance Expert

EDETEK Inc.; Argentina; Presencial; ARS 74.577.889 - 104.409.044; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive Medical, Vision, and Dental Insurance

Paid vacation time

Participation in the 401K Plan

Employee Assistance Program

Descripción de la vacante

EDETEK Inc. is seeking a Senior QA Specialist to lead quality assurance efforts in Argentina. This remote role involves conducting audits, ensuring compliance with regulations like GxP and performing risk assessments. Candidates should have a Bachelor's in life sciences or computer science and a minimum of 5 years QA experience, ideally in clinical research or regulated software environments.

The position offers comprehensive benefits including medical insurance, 401K plan participation, and paid vacation time.

Formación

• Minimum of 5 years of QA experience in clinical research or regulated software.
• Strong knowledge of GxP, ICH-GCP, and 21 CFR Part 11.
• Experience in conducting audits and managing CAPAs.

Responsabilidades

• Conduct internal audits and vendor audits.
• Ensure compliance with GxP, ICH-GCP, and internal quality standards.
• Act as a QA liaison across departments.

Conocimientos

Effective communication in English

Independence and initiative

Collaboration skills

Proficiency with Microsoft Office

Educación

Bachelor's degree in life sciences, computer science, or related field

Descripción del empleo

EDETEK Inc. is seeking a Senior QA Specialist to lead quality assurance efforts in Argentina. This remote role involves conducting audits, ensuring compliance with regulations like GxP and performing risk assessments. Candidates should have a Bachelor's in life sciences or computer science and a minimum of 5 years QA experience, ideally in clinical research or regulated software environments.

The position offers comprehensive benefits including medical insurance, 401K plan participation, and paid vacation time.