Auditor I QA

About the role

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Responsibilities

• Conducts audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs) and work instructions (WIs), contracts and project-specific requirements.
• Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs.

Job Responsibilities

• General Profile – Syneos Health Audits
  • Plans and conducts assigned audits.
  • Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
  • Reviews responses to audit findings for appropriateness and completeness.
  • Closes assigned audits.
• Customer Audits/Inspections
  • Prepares for and hosts or supports customer audits.
  • Assists senior QA personnel in hosting or supporting Regulatory Authority Inspections.
• Supervision
  • Normally receives detailed instructions on day-to-day work and new assignments.
• Other Tasks
  • Performs other work-related duties as assigned.
  • Moderate travel may be required (up to 50%).

Requirements

• Requires a Bachelor’s degree in the science/health care field or equivalent with some experience in GCP and GxP quality assurance auditing.
• Some knowledge of GCP and GxP regulatory requirements.
• Knowledge of Medical and technical terminology related to the audit types to be conducted.
• Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency).
• Able to handle multiple tasks to meet timelines in a dynamic environment.
• Good organizational, presentation and interpersonal skills.
• Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.
• Ability to provide constructive feedback.
• Good communication skills and the ability to write concise, accurate reports and other necessary documentation.

Benefits

• Company car or car allowance.
• Health benefits including Medical, Dental and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

Pay

Salary Range: $47,000.00 – $79,900.00. Actual salary will vary based on qualifications, skills, competencies, and proficiency for the role.