Quality - Audit & Inspection, Senior Specialist (Contract)

Accountabilities

The Quality Audit & Inspection Senior Specialist will support audit management operations, quality documentation processes, stakeholder coordination, and continuous improvement activities.

• Support the planning, coordination, and scheduling of GCP, GVP, and GLP audits and inspections.
• Cook up audit logistics, including stakeholder communications, meeting scheduling, audit notifications, agendas, and related correspondence.
• Aid audit teams before, during, and after audits by organizing documentation and supporting execution activities.
• Collect, organize, and maintain pre-audit documentation, investigator site audit requests, and quality records from applicable systems.
• Support the management, tracking, and progression of audit observations, inspection findings, and corrective and preventive action (CAPA) records.
• Review CAPA evidence packages for completeness, accuracy, and alignment with submission requirements before quality review.
• Maintain CAPA documentation, supporting evidence, records, and lifecycle updates within document management and quality systems.
• Monitor deadlines, milestones, and outstanding actions while proactively following up with responsible stakeholders.
• Generate status reports and provide updates related to audit ownership, progress, and CAPA completion.
• Cook up recurring team meetings by preparing agendas, supporting materials, meeting logistics, minutes, action items, and follow-up activities.
• Support cross-functional meetings, system implementations, process improvements, and change management initiatives.
• Gather stakeholder feedback and contribute to improvements involving processes, tools, templates, and team resources.
• Maintain SharePoint sites, document repositories, templates, trackers, and knowledge management resources to ensure accessibility and accuracy.
• Participate in continuous improvement initiatives designed to enhance audit readiness and quality operations.

Requirements

• Experience in quality, compliance, audit support, or regulated environments, along with strong organizational and communication skills.
• Bachelor’s degree in Life Sciences, Quality, Business Administration, Healthcare, or a related discipline preferred.
• Experience supporting quality, compliance, audit, inspection, clinical research, pharmacovigilance, laboratory, or other regulated industry activities preferred.
• Familiarity with quality management systems, document management systems, electronic trial master files (eTMF), SharePoint, and Microsoft Office applications preferred.
• Working knowledge of GCP, GVP, GLP, and quality management principles.
• Strong organizational and project coordination skills with the ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication skills with the ability to collaborate effectively across teams and organizational levels.
• Strong attention to detail and experience managing documentation, records, and compliance-related information.
• Ability to prepare meeting agendas, minutes, reports, and professional communications.
• Ability to maintain confidentiality and appropriately handle sensitive quality and compliance information.
• Strong problem-solving mindset with an interest in process improvement and operational efficiency.
• Demonstrated strengths in organization, planning, stakeholder management, accountability, adaptability, and follow-through.

Benefits

• Competitive contract pay range of $55-$60 per hour.
• Opportunity to contribute to quality and compliance initiatives within a highly regulated environment.
• Exposure to global audit, inspection, and quality management processes.
• Collaborative work environment involving cross-functional teams and industry experts.
• Opportunity to strengthen expertise in GCP, GVP, GLP, CAPA management, and audit operations.
• Experience supporting continuous improvement initiatives and quality system enhancements.
• Contract role with potential for professional growth within the life sciences and healthcare industry.