Remote Tech Compliance & QA Associate

WCG Clinical, Inc.; Indianapolis (IN); On-site; USD 52,000 - 82,000; Full time

Job summary

WCG is seeking an Associate, Compliance & QA (Technology) to support compliance across Technology Solutions teams. You will help ensure systems meet regulatory requirements and quality standards.

You will collaborate with IT, engineering, and staff to maintain the Quality Management System, perform audits, and assist with CAPA and validation activities. Remote work options may apply in the US.

Qualifications

• Two to four years of quality/regulatory compliance experience.
• Knowledge of FDA and ICH regulations and GCP guidelines.
• Experience supporting customer/sponsor audits of processes and documentation.
• Knowledge of 21 CFR Part 11 scope and CV processes.
• Experience documenting validation efforts for clinical systems.

Responsibilities

• Maintain and enforce WCG Quality Management System standards.
• Educate staff on quality standards and best practices.
• Develop and revise internal technology standards and SOPs.
• Assist with validation deliverables for systems in trials.
• Support investigations of CAPA, deviations, and NTFs.
• Conduct internal audits and assist external audits.

Skills

Quality assurance experience

Regulatory compliance knowledge

FDA and ICH knowledge

GCP guidelines

Computerized System Validation

Internal/external audits

Technical writing

Multitasking

Education

Bachelor's degree in science/tech

Tools

Computerized System Validation tools

Job description

WCG is seeking an Associate, Compliance & QA (Technology) to support compliance across Technology Solutions teams. You will help ensure systems meet regulatory requirements and quality standards.

You will collaborate with IT, engineering, and staff to maintain the Quality Management System, perform audits, and assist with CAPA and validation activities. Remote work options may apply in the US.