About the Role:
iSupport Worldwide is seeking a detail-oriented and proactive Quality Assurance Coordinator to support our mission of delivering compliant, high-quality CRO services and EDC technology solutions. Reporting to the QA Director, you will coordinate and manage key quality system activities to ensure compliance with SOPs, regulatory standards, and customer requirements.
Key Responsibilities:
- Coordinate and maintain core quality system processes, including supplier qualification, change management, CAPA (Corrective and Preventive Actions), deviation tracking, and complaint handling.
- Support internal, external, and regulatory audit preparation, documentation, and follow-up actions.
- Compile and report quality metrics and KPIs to management to drive continuous improvement.
- Administer personnel training and qualification systems, track required trainings, and maintain accurate employee training records.
- Manage document control and recordkeeping functions, ensuring all quality records are complete, version-controlled, and audit-ready.
- Prepare documentation packages for audits and inspections, and oversee retention and archiving of quality records.
What We're Looking For:
- Bachelor's degree in quality assurance, Life Sciences, or related field (or equivalent experience).
- Minimum of 3 years experience in a regulated industry (CRO, clinical research, pharmaceutical, or technology services preferred).
- Familiarity with GCP, HIPAA, and quality system regulations.
- Hands-on experience with supplier qualification, CAPA management, complaint handling, deviation tracking, and/or document control.
- Experience managing training systems or quality documentation platforms (Kivo or similar is a plus).
- Strong organizational and project management skills with attention to detail.
- Excellent written and verbal communication skills in English.
- Ability to manage multiple priorities and meet deadlines in a regulated environment.
