Senior QA & Compliance Leader - GxP & Audit Expert (Remote)

EDETEK Inc.; Colombia; Presencial; COP 151.026.983 - 218.150.087; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive Medical, Vision, and Dental Insurance

Paid vacation and sick days

Corporate holidays annually

Participation in the 401K Plan

Health Advocate and Employee Assistance Program

Descripción de la vacante

EDETEK Inc. is seeking a Senior QA Specialist responsible for ensuring compliance and quality in biometric services. The role involves auditing processes, reviewing documentation, and collaborating with cross-functional teams to meet GxP and regulatory standards.

With more than 5 years of QA experience required, candidates should possess strong communication and collaboration skills, along with a background in life sciences. This remote position welcomes applicants from South America.

Formación

• 5+ years of QA experience in clinical research or regulated software environments.
• Strong knowledge of GxP, ICH-GCP, and regulatory standards.
• Proven experience in conducting audits and managing CAPAs.

Responsabilidades

• Conduct audits and review quality management system documents.
• Collaborate with teams to ensure compliance with regulations.
• Lead risk assessments and identify process improvement initiatives.

Conocimientos

Communication in English

Collaboration across teams

Prioritization and execution

Proficiency in Microsoft Office

Educación

Bachelor's degree in life sciences or related field

Herramientas

eClinical QMS platforms

Microsoft Office applications

Descripción del empleo

EDETEK Inc. is seeking a Senior QA Specialist responsible for ensuring compliance and quality in biometric services. The role involves auditing processes, reviewing documentation, and collaborating with cross-functional teams to meet GxP and regulatory standards.

With more than 5 years of QA experience required, candidates should possess strong communication and collaboration skills, along with a background in life sciences. This remote position welcomes applicants from South America.