Quality Assurance Coordinator

Quality Assurance (QA) Coordinator

Location: Philippines (Remote)

Schedule: Full-time Requires consistent overlap with U.S. Pacific Time

Level: Mid-Level Individual Contributor

Compensation: Up to $1,000 USD per month

About the Company

We are representing a growing organization that operates at the intersection of clinical research services (CRO) and clinical trial technology. The company builds and supports a modern software platform used in clinical studies and also provides CRO services to pharmaceutical, biotech, medical device, and research partners.

Because they work in a highly regulated, audit-heavy environment, their Quality Management System (QMS) is a core part of the business. They are seeking a QA Coordinator to centralize and strengthen quality operations across the company.

The team is small, collaborative, detail-oriented, and values people who are proactive, organized, and not afraid to speak up or remind others of deadlines.

About the Role

This is a newly created role designed to support the QA Director by owning day-to-day quality system activities. The QA Coordinator will manage recurring QMS processes, maintain documentation and records, support audits, and ensure the organization is consistently meeting regulatory expectations.

Although the role has no direct reports, it requires someone who can coordinate across teams, follow up consistently, and mobilize people to complete required tasks (training, documentation, etc.).

This position will be supported through an onboarding process and will work closely with the QA Director, Operations, and other cross-functional teams.

Key Responsibilities

Quality System & Compliance

• Coordinate supplier qualification and requalification
• Support CAPA management, nonconformity tracking, and complaint handling
• Assist in internal, external, and regulatory audit preparation
• Organize audit documentation, track findings, and follow up on corrective actions
• Maintain and report key quality metrics and KPIs
• Ensure organization-wide adherence to SOPs and regulatory standards

Training & Qualification Tracking

• Assign and track department and role-based training
• Maintain complete training records and monitor expirations
• Coordinate qualification reviews with managers
• Work with HR and department leads to ensure no training gaps

Document Control

• Issue, revise, retire, and distribute SOPs and controlled documents
• Maintain clean, version-controlled, audit-ready files
• Prepare documentation packages for inspections
• Oversee record archiving and retention per company policy.

Required Qualifications

• 3+ years of experience in a regulated environment (CRO, clinical research, pharmaceuticals, medical device, hospital systems, or regulated technology)
• Strong experience in quality processes: CAPAs, document control, audits, supplier qualification
• Experience with QMS or document control platforms (e.g., Kivo or similar)
• Strong written and spoken English (critical requirement)
• Experience working with SOPs and quality documentation
• Highly organized, detail-oriented, proactive, and comfortable coordinating across teams
• Ability to work part of the schedule in U.S. Pacific hours.

Nice to Have

• Knowledge of GCP, HIPAA, FDA regulations
• Experience preparing for audits or regulatory inspections
• Experience in small, fast-paced, or early-stage organizations
• Prior work in CRO operations or hospital/healthcare systems.

Work Environment & Additional Notes

• Fully remote from the Philippines
• MondayFriday schedule; flexibility in working hours but requires consistent overlap with U.S. PT
• No travel required
• Company provides laptop and IT security setup.
• Strong culture of collaboration, openness, and proactive communication
• Team appreciates people who speak up, identify problems early, and help improve processes