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Senior Specialist, Quality Audit & Inspection

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

đź’µ $55 - $60 / hour

⏳ Contract/Temporary

đźź  Senior

🦅 H1B Visa Sponsor

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Logo of Vertex Pharmaceuticals

Vertex Pharmaceuticals

1001 - 5000 employees

Founded 1989

🧬 Biotechnology

đź’Š Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.

đź“‹ Description

• 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.

🎯 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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