QA Process and System Specialist

 Posted a month ago
     
2-5 years experience
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AI Summary

The QA Process and System Specialist will lead third-party audit coordination and oversee CAPA progression and site deviations. They will also serve as the primary liaison for SOP reviews and support computerized system validation and change management.

QA Process and System Specialist

Location: Fully Remote (South Africa or South America preferred)

Company: Clinglobal

Reports to: Director Quality Assurance and Compliance


Clinglobal is a global, science-based, quality-driven Contract Research Organization (CRO) dedicated to accelerating innovation in animal health. We provide streamlined product development services, regulatory support, and quality assurance across our network of facilities and partners.

We are looking for a detail-oriented and proactive QA professional to join our team in a fully remote capacity.


As QA Process and System Specialist, you will play a critical role in maintaining and enhancing our quality systems across the Clinglobal group. Reporting directly to the Director of Quality and Compliance, you will be the primary lead for audit coordination and process oversight in a regulated environment (GLP/GCP). This is a fully remote position with minimal travel.


Key Responsibilities

  • Primary lead for scheduling and coordinating third-party qualification audits.
  • Monitor and oversee CAPA (Corrective and Preventive Actions) progression and site deviations, ensuring timely resolution and effectiveness.
  • Facilitate receipt, distribution, and tracking of Sponsor and/or Regulatory audit reports and responses.
  • Serve as the primary QA liaison for review of global Standard Operating Procedures (SOPs).
  • Provide backup support for study-based audits across Clinglobal companies as required.
  • Review of Computerized System validation and change management documents.
  • Contribute to continuous improvement of QA processes and systems.


Requirements

  • 3–5 years of Quality Assurance experience in a regulated environment (GLP or GCP preferred; pharmaceutical, CRO, or animal health experience is a strong advantage).
  • Strong knowledge of audit processes, CAPA management, and SOP lifecycle.
  • Excellent organizational, communication, and interpersonal skills for global collaboration.
  • Proficiency in English (written and spoken); additional languages are a plus.
  • Self-motivated, able to work independently and manage workload across time zones.
  • Based in South Africa or South America (preferred for time zone alignment).
  • Willingness to undertake minimal travel if occasionally required.


What We Offer

  • Competitive salary and benefits package.
  • Fully remote working arrangement with flexible hours.
  • Opportunity to work on global projects in the growing animal health sector.
  • Supportive environment focused on quality, innovation, and work-life balance.


If you are a quality-driven professional with a proactive approach and solid QA experience in regulated environments, we’d love to hear from you!


Applications reviewed on a rolling basis. Clinglobal is an equal opportunity employer.

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