Quality Analyst (Remote - US)

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality Analyst in the United States.

This role offers a key opportunity to support and enhance an organization’s quality program within a dynamic, regulatory-driven environment. The Quality Analyst will ensure compliance with internal Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and applicable federal regulations, contributing to the integrity of research and operational processes. The position requires collaboration across teams, facilitating audits and inspections, and driving continuous improvement initiatives. The ideal candidate will analyze quality trends, resolve issues, and provide actionable insights to management. Remote work flexibility is offered, allowing you to operate efficiently while participating in high-impact projects. This role also emphasizes professional growth, knowledge sharing, and supporting organizational excellence in quality management.

Accountabilities:

• Assist with implementation, documentation, and maintenance of quality program procedures.
• Maintain up-to-date knowledge of SOPs, federal regulations, guidance documents, and accreditation standards.
• Support and participate in internal and external audits, regulatory inspections, and review of new processes or services.
• Collect, analyze, and report data on quality events, trends, and risks; assist with Corrective/Preventive Actions (CAPAs).
• Collaborate with staff to lead continuous improvement initiatives and support strategic projects.
• Act as a functional area Subject Matter Expert, providing training and guidance to team members.
• Represent the team in departmental meetings, suggesting and leading process improvements.

• Bachelor’s degree or equivalent work experience.
• Minimum 3 years’ experience in clinical research, healthcare, or GxP environments.
• Knowledge of inspection and quality control methods, techniques, and documentation.
• Familiarity with federal regulations for human research (21 CFR 50, 56, 312, 812; 45 CFR 46) is preferred.
• Strong organizational skills with the ability to manage multiple priorities without compromising quality.
• Excellent written and verbal communication skills; ability to interact effectively with staff at all levels.
• Proficiency in Microsoft Office suite and ability to learn new software as required.
• Ability to work independently, exercise sound judgment, and resolve problems effectively.