Quality Assurance & Compliance Specialist I

Ceridian HCM, Inc.; Oakland Village (TN); Híbrido; USD 55.000 - 75.000; Jornada completa

Descripción de la vacante

Ceridian HCM, Inc. seeks a Quality Specialist I to assist Quality Management in monitoring GCP regulatory compliance and quality in clinical trial activities. You will collaborate with cross-functional teams and external partners to ensure compliance initiatives are met.

The role supports internal audits, document control, and eQMS activities, while helping with CAPA and quality improvements. Strong communication and organizational skills are essential.

Formación

• Bachelor's degree preferred; 1–2 years of related experience and/or training.
• Experience supporting quality and regulatory activities is valuable.
• Strong written and verbal communication and audit readiness.

Responsabilidades

• Assists in scheduling and organizing internal and external assessments.
• Performs internal assessments including computer systems validations and audits.
• Participates in remote assessments of vendors on a risk-based schedule.
• Maintains QRS KPIs and other metrics for timely decision making.
• Supports eQMS maintenance, documents handling, and change control.
• Assists with quality and regulatory advisement to project managers.
• Contributes to root cause analyses and CAPA for nonconformances.
• Tracks non-conformances, customer complaints, audits, and document controls.
• Organizes and archives electronic and hard-copy quality records.
• Supports creation and revision of quality documents within eQMS.
• Composes routine correspondence and coordinates meeting logistics.
• Performs other duties as assigned.

Conocimientos

Attention to detail

Planning

Problem solving

Organizational skills

Communication skills

Team collaboration

Educación

Bachelor's degree

Descripción del empleo

Ceridian HCM, Inc. seeks a Quality Specialist I to assist Quality Management in monitoring GCP regulatory compliance and quality in clinical trial activities. You will collaborate with cross-functional teams and external partners to ensure compliance initiatives are met.

The role supports internal audits, document control, and eQMS activities, while helping with CAPA and quality improvements. Strong communication and organizational skills are essential.