Senior Coordinator, Research Operations - Quality Assurance

Summary

Texas Children’s Hospital Center for Vaccine Development (TCH-CVD) at Baylor College of Medicine is one of the leading vaccine development centers in the world developing low-cost effective vaccines against neglected tropical and emerging diseases that can be used in low- and middle-income countries. We are currently seeking a Senior Coordinator, Research Operations - Quality Assurance candidate that is responsible for performing various administrative and logistical duties in support of the Section of Pediatric Tropical Medicine at Baylor College of Medicine vaccine initiatives.  The position coordinates and administers quality assurance and regulatory research and administrative projects. The position collaborates with members of the quality assurance, quality control and regulatory affairs teams and works closely with various units in the organization and with Texas Children’s Hospital Center for Vaccine Development (TCH-CVD) and its partners.

Job Duties

• Coordinates the day to day research operations.
• Coordinates meetings, events, and other functions.
• Coordinates quality assurance and assist with safety programs.
• 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.
• Provide operational, administrative and logistical support for the Quality Assurance and Regulatory Affairs units. 
• Support intradepartmental and external institution personnel.
• Assure distribution of information between personnel involved in implementation of research projects.

Minimum Qualifications

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

Preferred Qualifications

• Bachelor’s degree in a health-science discipline
• 1-3 years quality experience
• Proficiency with MS Word, Excel and Adobe
• Proficiency with document control and reference management software
• 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
• Requires excellent written and oral communication skills
• Prior experience with data management of research and regulated protocols may be required
• 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 
• Ability to perform detail‐oriented work with a high level of accuracy
   

 

 

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

 

 

 18591