Vertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Senior Specialist, Quality Audit & Inspection
Location
United States
Posted
2 days ago
Salary
$55 - $60 / hour
Seniority
Senior
Job Description
Senior Specialist, Quality Audit & Inspection
Vertex Pharmaceuticals
• Provide operational, administrative, and process support to the Audit and Inspection Management team. • Collaborate with cross-functional and external stakeholders to facilitate audit planning. • Maintain audit-related records and documentation, and assist in ensuring timely progression and closure of audit deliverables. • Support the management and progression of audit and inspection observation and CAPA records within the applicable quality management system. • Lead coordination of recurring team meetings and prepare meeting agendas and supporting materials. • Maintain and organize team SharePoint sites, document repositories, folders, tools, templates, and reference materials.
Job Requirements
- Bachelor's degree in Life Sciences, Quality, Business Administration, Healthcare, or related discipline preferred.
- Experience supporting quality, compliance, audit, inspection, clinical research, pharmacovigilance, laboratory, or regulated industry activities preferred.
- Experience working with quality management systems, document management systems, electronic trial master files (eTMF), SharePoint, and Microsoft Office applications preferred.
Benefits
- Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
- Eligible for overtime pay, in accordance with federal and state requirements.
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