Tech Compliance & QA Associate (GxP, FDA/HIPAA)

Wcg-Clinical; United States; Remote; USD 52,000 - 82,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Tuition reimbursement

Paid holidays

Job summary

WCG seeks an Associate, Compliance & QA (Technology) to support the maintenance of the Quality Management System across Technology Solutions, including IT, infrastructure and software development, ensuring compliance with GxP, 21 CFR Part 11, GDPR and HIPAA.

You will support internal and external audits, CAPA investigations, training, and the creation of validation deliverables, while collaborating with cross‑functional teams to uphold high regulatory standards and timely improvements.

Qualifications

• Two to four years’ experience in a quality/regulatory compliance position.
• Knowledge of FDA/ICH, GCP guidelines as they apply to clinical studies.
• Experience supporting customer/sponsor audits and documentation.
• Knowledge of 21 CFR Part 11 scope and Computerized System Validation.
• Excellent written and oral communication and organizational skills.

Responsibilities

• Maintain and enforce the Quality Management System and quality dept standards.
• Support quality goals, objectives, and process improvements.
• Educate staff on quality standards and best practices.
• Author/revise internal technology standards (policies, SOPs).
• Support validation, implementation, and change management of systems.
• Assist with CAPA investigations, deviations, and notes to file.
• Conduct internal audits to ensure compliance with processes and regulations.
• Support external audits including preparation and findings resolution.
• Stay current with quality legislation and regulatory practices.

Education

Bachelor’s degree in a scientific, technical or related field

Tools

CAPA management tools

Validation documentation tools

Job description

WCG seeks an Associate, Compliance & QA (Technology) to support the maintenance of the Quality Management System across Technology Solutions, including IT, infrastructure and software development, ensuring compliance with GxP, 21 CFR Part 11, GDPR and HIPAA.

You will support internal and external audits, CAPA investigations, training, and the creation of validation deliverables, while collaborating with cross‑functional teams to uphold high regulatory standards and timely improvements.