QA Auditor I – GxP Compliance & Audits

Syneos Health/ inVentiv Health Commercial LLC; Miami (FL); On-site; USD 47,000 - 80,000; Full time

Benefits offered by this job

Company car

Health benefits

401k match

Employee stock purchase plan

Bonus eligibility

Paid time off

Job summary

Syneos Health in Miami, FL is seeking an Auditor I QA to conduct audits ensuring compliance with applicable regulations, SOPs, WIs, contracts and project requirements. You will host and support customer audits and regulatory inspections in line with QA procedures.

The role includes planning and performing audits, issuing audit reports, reviewing responses, closing audits, and assisting with regulatory inspections, with potential travel up to 50%.

Qualifications

• Bachelor's degree in science/healthcare with experience in GCP and GxP QA auditing.
• Knowledge of regulatory requirements (GCP/GxP).
• Strong communication and ability to write concise reports.

Responsibilities

• Plan and conduct assigned audits.
• Write and issue audit reports, communicating findings clearly.
• Review responses to audit findings for adequacy and completeness.
• Close assigned audits.
• Prepare for and host or support customer audits.
• Assist senior QA in hosting or supporting regulatory inspections.

Skills

GCP knowledge

GxP auditing

Report writing

Interpersonal skills

Communication skills

Multi-tasking

Microsoft Office

Education

Bachelor's degree in science/healthcare

Tools

Microsoft Office

SharePoint

Job description

Syneos Health in Miami, FL is seeking an Auditor I QA to conduct audits ensuring compliance with applicable regulations, SOPs, WIs, contracts and project requirements. You will host and support customer audits and regulatory inspections in line with QA procedures.

The role includes planning and performing audits, issuing audit reports, reviewing responses, closing audits, and assisting with regulatory inspections, with potential travel up to 50%.