Senior Coordinator, Research Operations - Quality Assurance

Summary

Texas Children’s Hospital Center for Vaccine Development (TCH-CVD) at Baylor College of Medicine is recognized as one of the world’s leading vaccine development centers. Our mission is to create low-cost, effective vaccines targeting neglected tropical and emerging diseases, with a focus on improving access in low- and middle-income countries.

We are seeking a Senior Coordinator, Research Operations Specialist to support vaccine initiatives within the Section of Pediatric Tropical Medicine at Baylor College of Medicine. This role is responsible for coordinating quality assurance, regulatory research, and administrative projects. The position involves performing a variety of administrative and logistical tasks, collaborating closely with quality assurance, quality control, and regulatory affairs teams, and working with internal departments and consortium partners to ensure compliance and operational excellence.

• Generic Duties:
  • Organize information into spreadsheet format from data collection
  • Prepare document templates using Adobe Acrobat, MS Word and Excel
• Specific Duties:
  • Maintain the document control system for laboratory notebooks, safety data sheets, certificate of analysis, certificate of conformance, master stability plans/stability testing results, etc.
  • Assists with the quality management software system
  • Maintain shipments, inventory, stability, audit and personnel training files
  • Assess and approve raw materials
  • Maintain the change control system
  • Assist with equipment maintenance, calibrations and preventive maintenance
  • Write, revise and approve SOPs
  • Assist with the Annual GMP training planning
  • Review and maintain personnel training records
  • Perform other job-related duties as required or as assigned

• High School diploma or GED.
• Four years of relevant experience.

• Bachelor’s degree in a health-science discipline
• 1-3 years quality experience
• Proficiency with MS Word, Excel and Adobe
• Proficiency with document control
• Basic knowledge of quality management system
• Basic understanding and application of principles, concepts, practices and standards, and knowledge of industry practices
• Basic understanding of GxPs (GCPs, GLPs, GMPs) and regulatory guidelines such as FDA and ICH guidelines
• Ability to perform detail‐oriented work with a high level of accuracy.
• Requires excellent written and oral communication skills.
• Must be resourceful and able to work independently, with limited supervision.
• Ability to multitask, problem solve, set and meet deadlines.
• Ability to work collaboratively with all levels of staff and range of personalities, culture and working styles.
• Excellent organizational skills.

Work Authorization Requirement: This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

Baylor College of Medicine fosters diversity among its students, trainees, faculty, and staff as a prerequisite to accomplishing our institutional mission and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.