Clinical QA Associate — Hybrid Work & Growth

Ctifacts; Raleigh (NC); Hybrid; USD 52,000 - 78,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Generous health benefits and vacation

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services in the United States is seeking a Clinical Trial Quality Assurance Associate to support auditors and regulatory inspections, and help coordinate QA activities.

You will work in a global CRO environment, with roles in SOP quality control, CAPA tracking, and QMS coordination, with hybrid work options in Raleigh, NC.

Ideal candidates have a bachelor’s degree and 0–1 year QA exposure, strong communication skills, and a basic understanding of GxP.

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• 0–1 year of work experience in QA or a regulated environment is preferred.
• Basic understanding of GxP Guidelines, including ICH/GCP and country-specific regulations.
• Excellent verbal and written communication skills.

Responsibilities

• Assist Auditors with Sponsor audits and regulatory authority inspections.
• Coordinate regional testing for annual Business Continuity Plan updates.
• Track audit findings, deviations, and CAPAs in the QA system.
• Quality control SOPs for formatting and consistency.
• Support distribution of SOPs and document control.
• Assist in coordinating QMS activities and related documentation.

Skills

Verbal communication

Written communication

GxP Guidelines awareness

Education

Bachelor’s Degree or equivalent combination of education and experience

Job description

CTI Clinical Trial and Consulting Services in the United States is seeking a Clinical Trial Quality Assurance Associate to support auditors and regulatory inspections, and help coordinate QA activities.

You will work in a global CRO environment, with roles in SOP quality control, CAPA tracking, and QMS coordination, with hybrid work options in Raleigh, NC.

Ideal candidates have a bachelor’s degree and 0–1 year QA exposure, strong communication skills, and a basic understanding of GxP.