Quality Specialist, CQA

The Clinical QualitySpecialist, under the direction of the CQA management team, will be responsibleto support Clinical Quality and their operations in ensuring compliance of the company's clinical studies, vendor management, and inspection readinessaccording to approved procedures, global regulations and ICH, GxP requirements.

Position Details

• Support the processing of audit reports, change controls, deviation, andaudit plans
• Support CQA team in the coordination, investigation, escalation, andresolution of issues identified during Clinical Quality Operations
• Support scheduling of audits with internal and external stakeholders
• Collect and generate metrics for Clinical Quality Operations.
• Assist in gathering requirements for improvements and ongoing maintenanceby participating in meeting/workshops with Site Process Owners and businessSMEs
• Participate in CQA meetings and the additional forums including but not limitedto Inspection Readiness and Regulatory Inspections
• Assist Clinical Quality in supporting internal and external stakeholdersin the processing of deviations, Quality Investigations, and audits
• Follow-up on requests, issues, and projects and report statuses tomanager and CQA team
• Support the management and maintenance of the Clinical Quality VendorManagement database.
• Provide CQA support through training management and onboarding of new employees.
  
  

Academic/Technical Qualifications

• Bachelor’s degree or higher in relevant computer, technical, quality, scientificdiscipline, preferably multi-disciplinary with a strong technical and qualitybackground
• Minimum of 2-5 years of experience in commercial pharma, CRO, clinicalpharma, or healthcare facility
• Proficient in MS Word, Excel, and Quality System processes. Experiencewith Veeva, TrackWise, and ComplianceWire is a plus.
• Understanding and working knowledge of US FDA and European regulatoryrequirements. Knowledge of Regulatory Compliance, ICH Guidelines, GxP standards