Remote Tech Compliance & QA Associate

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

Job summary

WCG Clinical, Inc. is seeking an Associate focused on Compliance & QA (Technology) to support a robust Quality Management System across Technology Solutions. You will help ensure regulatory alignment including FDA, ICH, GxP, and 21 CFR Part 11, partnering with IT and software teams.

The role covers policy development, training delivery, and participation in internal and external audits, with opportunities for cross-departmental impact and professional growth in a remote-capable environment.

Qualifications

• Two to four years’ experience in a quality/regulatory compliance position.
• Knowledge of FDA & ICH regulations and GCP guidelines for clinical studies.
• Experience supporting audits of processes, training, documentation, etc.
• Knowledge of 21 CFR Part 11 scope and Computerized System Validation.
• Experience delivering training on company standards and regulatory requirements.

Responsibilities

• Engages in development, maintenance, and enforcement of the Quality Management System.
• Supports maintenance of quality goals, objectives, and process improvements.
• Educates staff on quality standards and best practices.
• Authors and revises internal technology standards, SOPs, and policies.
• Supports validation and change management of systems per regulatory guidance such as GDPR and HIPAA.
• Investigates Quality Events, CAPA, deviations, and notes to file; meets timelines.
• Conducts internal audits to ensure compliance with processes and regulations.

Skills

Quality compliance

Regulatory knowledge

Audit support

Documentation

Cross-functional collaboration

Education

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

Tools

CSV processes

GxP frameworks

Regulatory guidelines

Job description

WCG Clinical, Inc. is seeking an Associate focused on Compliance & QA (Technology) to support a robust Quality Management System across Technology Solutions. You will help ensure regulatory alignment including FDA, ICH, GxP, and 21 CFR Part 11, partnering with IT and software teams.

The role covers policy development, training delivery, and participation in internal and external audits, with opportunities for cross-departmental impact and professional growth in a remote-capable environment.