Quality - Audit & Inspection, Senior Specialist (Contract)
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality - Audit & Inspection, Senior Specialist (Contract) based in the United States.
The Quality Audit & Inspection Senior Specialist will provide critical operational support for audit and inspection activities within a highly regulated environment.
This role supports quality teams across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practice (GLP) functions.
The position plays an important role in coordinating audits, maintaining compliance records, managing CAPA activities, and ensuring timely completion of quality deliverables.
Working closely with cross-functional and external stakeholders, this specialist will help strengthen audit readiness and continuous improvement initiatives.
The ideal candidate is detail-oriented, organized, and comfortable managing documentation, processes, and communications in a quality-focused environment.
This opportunity offers the chance to contribute to operational excellence and support reliable, compliant practices across global quality operations
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality - Audit & Inspection, Senior Specialist (Contract) based in the United States.
The Quality Audit & Inspection Senior Specialist will provide critical operational support for audit and inspection activities within a highly regulated environment.
This role supports quality teams across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practice (GLP) functions.
The position plays an important role in coordinating audits, maintaining compliance records, managing CAPA activities, and ensuring timely completion of quality deliverables.
Working closely with cross-functional and external stakeholders, this specialist will help strengthen audit readiness and continuous improvement initiatives.
The ideal candidate is detail-oriented, organized, and comfortable managing documentation, processes, and communications in a quality-focused environment.
This opportunity offers the chance to contribute to operational excellence and support reliable, compliant practices across global quality operations
Accountabilities:
- Support the planning, coordination, and scheduling of GCP, GVP, and GLP audits and inspections.
- Coordinate audit logistics, including stakeholder communications, meeting scheduling, audit notifications, agendas, and related correspondence.
- Assist 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.
- Coordinate 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.
- Support the development, review, and maintenance of audit questionnaires, assessment tools, and quality documentation.
- Participate in continuous improvement initiatives designed to enhance audit readiness and quality operations.
- 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.
- 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.
The Quality Audit & Inspection Senior Specialist will support audit management operations, quality documentation processes, stakeholder coordination, and continuous improvement activities.
Requirements:
The ideal candidate will bring experience in quality, compliance, audit support, or regulated environments, along with strong organizational and communication skills.