This is a fully remote position, open to applicants in United States.

📋 Description

• Provide operational, administrative, and procedural support to the Audit and Inspection Management team.

• Collaborate with cross-functional teams and external stakeholders to facilitate audit planning.

• Keep audit-related records and documentation up to date, assisting in ensuring timely progression and closure of audit deliverables.

• Aid in the management and tracking of audit and inspection observations and CAPA records within the relevant quality management system.

• Take the lead in coordinating regular team meetings, preparing meeting agendas and supporting materials.

• Organize and maintain team SharePoint sites, document repositories, folders, tools, templates, and reference materials.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Quality, Business Administration, Healthcare, or a related field is preferred.

• Prior experience supporting quality, compliance, audit, inspection, clinical research, pharmacovigilance, laboratory, or activities in regulated industries is preferred.

• Familiarity with quality management systems, document management systems, electronic trial master files (eTMF), SharePoint, and Microsoft Office applications is preferred.

🏝️ Benefits

• Compensation, medical benefits, fringe benefits, and other employment terms and conditions will be provided by the third-party agency partner upon offer.

• Eligible for overtime pay in accordance with federal and state requirements.