Remote Compliance & QA Associate (Tech)

WCG Clinical, Inc.; Hagåtña (GU); Remote; USD 52,000 - 82,000; Full time

Job summary

WCG Clinical, Inc. seeks an Associate, Compliance & QA (Technology) to support the company-wide Quality Management System across IT and software development.

You will help ensure regulatory compliance and participate in audits to uphold clinical trial standards. Responsibilities include validating systems, educating staff on QA standards, and collaborating with cross-functional teams to implement best practices.

Qualifications

• Bachelor’s degree in a scientific, technical or related field.
• 2–4 years of quality/regulatory compliance experience.
• Knowledge of FDA/ICH & GCP guidelines in clinical studies.
• Experience supporting audits of processes, documentation, and training.
• Experience with Computerized System Validation (CSV) and regulatory requirements.

Responsibilities

• Develop, maintain, and enforce the Quality Management System and quality standards.
• Support maintenance of quality goals, objectives, and process improvements.
• Educate staff on quality standards and best practices.
• Draft and revise internal technology standards (policies, SOPs).
• Support validation, change management, and regulatory alignment of systems used in clinical trials.
• Investigate Quality Events/CAPA, deviations, and notes to file; meet timelines.
• Conduct internal and external vendor qualification audits and audit prep.
• Maintain knowledge of quality legislation and regulatory best practices.

Skills

Quality Assurance

Regulatory Compliance

GxP knowledge

FDA/ICH knowledge

Validation

Technical writing

Communication

Education

Bachelor's degree in science or related field

Job description

WCG Clinical, Inc. seeks an Associate, Compliance & QA (Technology) to support the company-wide Quality Management System across IT and software development.

You will help ensure regulatory compliance and participate in audits to uphold clinical trial standards. Responsibilities include validating systems, educating staff on QA standards, and collaborating with cross-functional teams to implement best practices.