Remote Compliance & QA Specialist (Tech Systems)

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

Job summary

WCG Clinical, Inc. seeks an Associate, Compliance & QA (Technology) to support the maintenance of quality and regulatory standards across WCG Technology Solutions, including IT, software development and engineering. The role ensures compliance with regulatory guidelines and WCG’s Quality Management System.

The position partners with technical staff to achieve corporate compliance goals and execute validation and qualification activities for systems used in clinical trials.

Qualifications

• Bachelor’s degree in scientific/technical field or equivalent experience.
• 2–4 years in quality/regulatory compliance roles.
• Knowledge of FDA & ICH regulations and GCP.
• Experience supporting customer/sponsor audits of processes and docs.
• Knowledge of 21 CFR Part 11 and Computerized System Validation (CSV).
• Experience documenting validation deliverables for clinical systems.
• Strong written and verbal communication skills.

Responsibilities

• Maintain and enforce the Quality Management System and department standards.
• Support quality goals, objectives, and process improvements.
• Educate staff on quality standards and best practices.
• Draft and revise internal technology standards and SOPs.
• Assist validation and change management for systems to satisfy regulatory requirements (FDA, GDPR, HIPAA).
• Participate in CAPA investigations and deviation handling.
• Conduct internal audits and assist external vendor qualification audits.
• Support audit preparations and resolution of findings.

Skills

Quality compliance

Regulatory knowledge

Audit support

Documentation & writing

Regulatory communications

Education

Bachelor’s degree in science/tech

Tools

CSV processes

Regulatory software

Job description

WCG Clinical, Inc. seeks an Associate, Compliance & QA (Technology) to support the maintenance of quality and regulatory standards across WCG Technology Solutions, including IT, software development and engineering. The role ensures compliance with regulatory guidelines and WCG’s Quality Management System.

The position partners with technical staff to achieve corporate compliance goals and execute validation and qualification activities for systems used in clinical trials.