Quality Assurance Specialist

The Quality Assurance Specialist will conduct comprehensive quality assurance reviews in support of M3 Wake Research's clinical teams. This role involves collaborating with clinical research staff to address findings, provide recommendations for improvement, and ensure compliance within their area of expertise. The Quality Assurance Specialist will oversee audits and inspections, and work cross-functionally to support continuous quality enhancement across the organization.Essential Duties and Responsibilities:Including, but not limited to the following:Travel to M3 Wake Research sites to conduct internal quality assurance reviews of clinical trials and processes for adherence to SOPs, company policy, and regulations/standards.Prepare reports and discuss non-compliance and/or quality findings with internal customers as well as with Quality management. Track and follow up on the resolution of review findings.Provide guidance to clinical staff in resolving findings, implementing processes, and CAPA plans to include development, root case analysis, implementation, and evaluation of CAPA plans.Work closely with assigned clinical teams and site directors to identify gaps and ensure continuous process improvement in conjunction with Quality management.Assist in preparing for inspections by sponsors and regulatory agencies and participate in on site regulatory inspections as appropriate.Assist in implementing quality management plans including risk identification and assessment through data review and quality control processes.Provides consultation on corrective and preventive actions performed as a result of observations; follows-up and provides data required to determine the timeliness and effectiveness of corrective and preventive actions performed by the site staff and operational team. Assist with the development or enhancement of training materials.Conducts on-the-job training (OJT) and instructor-led training (ILT) for employees and new hires.Conduct review of training records to ensure assigned sites are maintaining compliance with training curriculum.Remain informed about developments in relevant clinical trial requirements, FDA, ICH, GCP, and guidelines within the US and other regions, as appropriate for M3 Wake Research.Identify and escalate significant compliance issues.Share quality topics and lessons learned to the organization.Assist individual sites in development of internal guidance documents to supplement corporate SOPs.Assist with quality incident and compliance investigations.