QA Auditor I — Regulatory Compliance & Audits

Syneos Health; Miami (FL); Presencial; USD 47 000 - 80 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Company car/allowance

Health benefits

401k match

Employee Stock Purchase Plan

Bonuses

Flexible PTO

Resumo da oferta

Syneos Health is hiring an Auditor I QA in the United States. You will conduct audits to assess compliance with regulations, SOPs, WIs, and contracts, and host customer audits and regulatory inspections. The role requires a bachelor’s degree in science/health care and knowledge of GCP/GxP.

Strong report writing, organization, and communication skills are essential. Travel up to 50% may be required. Join a global life sciences services leader focused on accelerating patient progress and

Qualificações

• Bachelor’s degree in science/health care field or equivalent with some experience in GCP and GxP quality assurance auditing.
• Knowledge of regulatory requirements; ability to write concise, accurate reports.
• Good organizational, presentation and interpersonal skills.

Responsabilidades

• Plans and conducts assigned audits.
• Writes and issues audit reports, ensuring clear communication of audit findings.
• Reviews responses to audit findings for appropriateness and completeness.
• Closes assigned audits.
• Prepares for and hosts customer audits.
• Assists senior QA personnel in hosting or supporting Regulatory Authority Inspections.
• Normally receives detailed instructions on day-to-day work.
• Performs other work-related duties as assigned.
• Moderate travel may be required (up to 50%).

Conhecimentos

GCP knowledge

GxP auditing

Quality assurance

Regulatory terminology

Formação académica

Bachelor’s degree in science/health care

Ferramentas

Microsoft Office

SharePoint

Descrição da oferta de emprego

Syneos Health is hiring an Auditor I QA in the United States. You will conduct audits to assess compliance with regulations, SOPs, WIs, and contracts, and host customer audits and regulatory inspections. The role requires a bachelor’s degree in science/health care and knowledge of GCP/GxP.

Strong report writing, organization, and communication skills are essential. Travel up to 50% may be required. Join a global life sciences services leader focused on accelerating patient progress and