Remote Compliance & QA Associate (Tech)

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

Job summary

WCG Clinical, Inc. is seeking an Associate, Compliance & QA (Technology) to support the maintenance of quality standards across WCG Technology Solutions, including infrastructure, IT, software development, and engineering.

You will help ensure adherence to regulatory requirements and WCG’s Quality Management System. You will educate staff, develop internal technology standards, and assist in validation efforts to meet regulatory guidance such as FDA, ICH, GDPR, and HIPAA.

Qualifications

• Two to four years’ experience in a quality/regulatory compliance role.
• Knowledge of FDA & ICH guidelines and GCP as they apply to clinical studies.
• Experience supporting customer/sponsor audits of processes, training, documentation.
• Knowledge of 21 CFR Part 11 scope and Computerized System Validation.
• Experience executing Computerized System Validation in clinical trials.
• Experience delivering training on company standards and regulatory requirements.
• Ability to contribute to multi-department projects and communicate effectively.

Responsibilities

• Develop, maintain, and enforce the Quality Management System and quality standards.
• Support quality goals, objectives, and process improvements.
• Educate staff on quality standards and best practices.
• Author and revise internal technology standards, SOPs, and policies.
• Support validation, change management, and regulatory compliance activities.
• Investigate quality events, CAPAs, deviations, and notes to file.
• Conduct internal audits and external vendor qualification audits.
• Assist with external audits and findings resolution.
• Maintain up-to-date knowledge of quality regulations and best practices.

Skills

Regulatory knowledge

GCP guidelines

FDA & ICH familiarity

Written communication

Problem solving

Training delivery

Multi-department collaboration

Independent work

Education

Bachelor's degree in science/technical field

Job description

WCG Clinical, Inc. is seeking an Associate, Compliance & QA (Technology) to support the maintenance of quality standards across WCG Technology Solutions, including infrastructure, IT, software development, and engineering.

You will help ensure adherence to regulatory requirements and WCG’s Quality Management System. You will educate staff, develop internal technology standards, and assist in validation efforts to meet regulatory guidance such as FDA, ICH, GDPR, and HIPAA.