Senior QA & Compliance Lead — Remote

EDETEK Inc.; Peru (IL); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Comprehensive Medical, Vision and Dental Insurance

Paid vacation time and sick days

Corporate holidays annually

Participation in the 401K Plan

Health Advocate and Employee Assistance Program

Job summary

EDETEK Inc. in Peru is looking for a Senior QA Specialist to oversee compliance and quality in biometric services and computer systems. You'll conduct audits, collaborate with various teams, and ensure adherence to GxP and regulatory standards.

Ideal candidates will have over 5 years of QA experience, strong documentation skills, and a background in clinical research or regulated environments. This is a remote role, open to South American candidates.

Qualifications

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

Responsibilities

• Drive compliance and quality across biometric services and computer systems.
• Conduct internal audits and vendor audits.
• Ensure adherence to applicable regulations and internal quality standards.

Skills

Communication skills (English)

Collaboration skills

Adaptability

Attention to detail

Microsoft Office proficiency

Education

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

Tools

Electronic QMS platforms (e.g., ZenQMS)

Job description

EDETEK Inc. in Peru is looking for a Senior QA Specialist to oversee compliance and quality in biometric services and computer systems. You'll conduct audits, collaborate with various teams, and ensure adherence to GxP and regulatory standards.

Ideal candidates will have over 5 years of QA experience, strong documentation skills, and a background in clinical research or regulated environments. This is a remote role, open to South American candidates.