QA Specialist

Role:

• Develops and maintains quality monitoring plans for assigned programs. Executes and/or oversees implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
• Ensures agreed upon deliverables are completed within the timeframe established, including but not limited to, review and assessment of Quality Risk Management reports; coordination of quality risk mitigation plans for identified issues; quality reviews of key clinical trial documents, and review and planning of submission activities as needed.
• Supports Due Diligence activities, as requested
• Provides Good Clinical Practices (GCP) guidance to workgroups and to business partners.
• Ensure interpretation and consistency with compliance guidance provided. Assists in the facilitation of inspections by regulatory authorities for GCP

• Develops Quality Monitoring Plans and performs/oversees performance of quality
  monitoring activities for assigned projects or other projects/tasks, as assigned, according
  to agreed upon deliverables and established timelines.
• Provide ongoing compliance support to business partners, including but not limited to:
  • Preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk. Collaborates with applicable team members to develop risk mitigation plans.
  • Providing compliance support in the management and implementation of quality risk mitigation and inspection readiness actions
  • Collaborating with the Clinical Team business partners to share audit/inspection observations for lessons learned across protocol, and/or program, and working with appropriate groups to implement Corrective Action Plans (CAPAs).
• Provide compliance direction/support to applicable clinical team members on an ongoing basis.
• Performs quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities.
• Supports special projects, as assigned by supervisor. May mentor new employees.
• Provides appropriate support to assigned cross-functional workgroups.
• Responds independently to GCP-related compliance inquiries from other departments. Confers with quality professional staff when contacted for pro-active consultation to provide regulatory insight.
• Manages inspection preparation activities and supports business during health authority inspections

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