Clinical Trial QA Associate: Audits, SOPs & QMS

CTI Clinical Trial and Consulting Services; Covington (KY); Hybrid; USD 40,000 - 60,000; Full time

Benefits offered by this job

Hybrid work option

Health benefits

Paid time off

Job summary

CTI Clinical Trial and Consulting Services is seeking a QA Assistant to support the Quality Management System (QMS) activities, assist sponsor audits, regulatory inspections, and internal system audits, help with CAPA tracking, and ensure SOP formatting and documentation consistency across the organization.

In this role you will coordinate QMS procedures, maintain audit schedules, assist with vendor audits, and collaborate with QA professionals to learn and strengthen quality assurance

Qualifications

• 0-1 years of work experience in QA or related field.
• Basic understanding of GxP Guidelines, including ICH/GCP.
• Excellent verbal and written communication skills.

Responsibilities

• Assist auditors with sponsor audits and regulatory inspections to support the auditing process.
• Support regional testing and maintenance of the Business Continuity Plan.
• Assist in tracking audit findings, deviations and CAPAs within the QA framework.
• Ensure SOPs are consistent in formatting, spelling, and content.

Skills

GxP knowledge

Audit support

Documentation

Communication skills

Education

Bachelor's Degree or equivalent

Tools

QMS

Job description

CTI Clinical Trial and Consulting Services is seeking a QA Assistant to support the Quality Management System (QMS) activities, assist sponsor audits, regulatory inspections, and internal system audits, help with CAPA tracking, and ensure SOP formatting and documentation consistency across the organization.

In this role you will coordinate QMS procedures, maintain audit schedules, assist with vendor audits, and collaborate with QA professionals to learn and strengthen quality assurance