Clinical Trial QA Specialist

Visa Hunt; United States; Hybrid; USD 42,000 - 65,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Generous health benefits

Paid vacation packages

Job summary

CTI Clinical Trial and Consulting Services is a global CRO focused on advancing treatments for chronically and critically ill patients. This role supports QA activities, audits, SOP management, and QMS coordination from a hybrid US-based environment.

The role emphasizes collaboration with auditors, maintenance of quality records, and participation in CAPA tracking, with opportunities for growth in quality assurance responsibilities.

Qualifications

• Basic understanding of GxP Guidelines (ICH/GCP) and country-specific regulations.
• Excellent verbal and written communication skills.

Responsibilities

• Assist Auditors with Sponsor audits and regulatory inspections to facilitate auditing and inspection processes.
• Manage and initiate regional testing for the annual update of the Business Continuity Plan.
• Track audit findings, deviations and CAPAs identified in QA audits.
• Quality control of SOPs to ensure formatting, spelling, and consistency.
• Manage the distribution process for company SOPs.
• Lead process changes to improve LMS usage and implement them.
• Create/format document templates and trackers.
• Maintain quality records per SOPs.
• Collaborate with Auditors to learn and enhance QA responsibilities.
• Maintain audit schedules and track deliverables.
• Assist QA Audits with vendor audits, internal system audits, and computerised systems validation.
• Coordinate activities related to the QMS, including review of quality control documentation and user acceptance testing documents.
• Create procedures and work instructions relating to the QMS with consistent content quality.
• Support QMS owners/users with data entry in QMS.
• Assist with timely follow-up of deviations and CAPAs per SOPs.
• Assist with RFIs related to QMS.
• Support international region-specific functions.

Skills

GxP guidelines understanding

Verbal and written communication

Education

Bachelor’s degree or equivalent

Job description

CTI Clinical Trial and Consulting Services is a global CRO focused on advancing treatments for chronically and critically ill patients. This role supports QA activities, audits, SOP management, and QMS coordination from a hybrid US-based environment.

The role emphasizes collaboration with auditors, maintenance of quality records, and participation in CAPA tracking, with opportunities for growth in quality assurance responsibilities.