QA Analyst

SABAI GLOBAL, a leader in providing Institutional Review Board (IRB) services, works diligently to protect the rights, safety and welfare of human research participants who participate in research studies. We have an opening for an QA Analyst in a fully remote or hybrid role (if local to the St. Louis, MO area).

In this role, your PRIMARY DUTIES would include:

• Supports planning and execution of internal audits, external audits, regulatory inspections, and client audits by preparing documentation, maintaining records, and tracking responses to findings.
• Participates directly in the internal audit program and external audit activities, including regulatory inspections and client qualification audits.
• Responds to client qualification surveys and general requests for information, ensuring accuracy, timeliness, and compliance with Sabai Global policies.
• Assists in conducting investigation activities, including Quality Issue Reports (QIs) and Corrective and Preventive Action (CAPA) monitoring and closure.
• Serves as a pointofcontact for audit logistics, ensuring documentation is readily accessible and organized.
• Manages document control processes within the electronic Quality Management System (eQMS), including review, formatting, issuance, and archival of controlled records.
• Ensures adherence to ISO 9001:2015, FDA, GCP, NIH, and AAHRPP requirements in documentation practices.
• Supports harmonization of controlled documents across divisions, ensuring consistency and version control.
• Coordinates and manages administrative documentation for the Quality Division, including agendas, minutes, and reports, in collaboration with the Senior Manager, Quality.
• Provides project support for quality initiatives, including system qualifications, change control, and business continuity activities.
• Participates in crossfunctional project teams to ensure quality objectives are incorporated into deliverables.
• Assists in maintaining the Quality Master Calendar and tracking progress of quality projects and deliverables.
• Coordinates and leads quality and compliance training activities, including tracking attendance and ensuring completion of required courses.
• Assists in developing training materials for quality initiatives, audits, and regulatory updates.
• Ensures compliance with training documentation requirements and supports auditreadiness for training records.
• Serves as an administrator for the company’s Quality Management System (ZenQMS), assisting in system workflows, oversight, and system building.
• Plays a primary role in quality control activities of the QMS, ensuring accuracy, completeness, and compliance of records, workflows, and outputs.
• Supports configuration, testing, and implementation of new QMS modules to align with evolving quality and regulatory requirements.
  
  

SUCCESSFUL CANIDATES will have:

• Bachelor’s degree in life sciences, business administration, healthcare, or related discipline.
• Minimum 24 years of experience in quality assurance (QA), document control, regulatory compliance, or a directly related field.
• Experience with electronic Quality Management Systems (e.g., ZenQMS), including administration, workflow configuration, and system implementation.
• Familiarity with Institutional Review Boards (IRBs), Institutional Biosafety Committees (IBCs), or clinical research operations strongly preferred.
• Certification through the American Society for Quality (ASQ) or a similar professional organization highly preferred.
  
  

Sabai Global is an Equal Opportunity Employer. Candidates needing assistance with the application process, due to differing abilities, should contact [email protected].