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 all members of the quality assurance and regulatory affairs team and works closely with various units in the organization and with Texas Children's Hospital Center for Vaccine Development (TCH-CVD) and its partners.
Provide operational, administrative and logistical support for the TCH-CVD Quality Assurance and Regulatory Affairs unit
Coordinate and participate in planning and developing QA/RA methods for project implementation and operational activities
Review records and reports of activities to ensure that progress is being accomplished toward specified TCH-CVD project objectives
Recommend modifications to methods or procedures as required to direct and redirect activities and ensure that objectives of TCH-CVD are met
Prepare and maintain electronic and/or hardcopy QA/RA documents that includes drafting, proofreading, formatting and editing
Review and maintain personnel training records
Maintain document control systems, filing systems for both physical and electronic program files
Perform data entry and generates reports
Collaborate and participate in development of databases for TCH-CVD projects
Assist in managing and organizing training and advisory meetings both domestic and international, as needed
Prepare and distribute agendas and minutes for QA/RA meetings, as needed
Organize information into spreadsheet format from data collection
Prepare general document templates using Adobe Acrobat and MS Word and Excel
Interact with faculty, staff and students to promote the goals and objectives of TCH-CVD.
Perform general clerical duties, including shipping of various documents and packages
Maintain clear communication regarding expectations
Take personal responsibility and accountability for correcting any issues that may arise
Required: High School graduate/GED. Preferred: Bachelor degree in Business Administration, Health Administration, or relevant degree as determined by HR.
One year of directly related experience required if candidate has a Bachelor degree in Business Administration or Health Administration, or relevant degree as determined by HR.
Required: Five years of directly related experience without a Bachelor degree.
NOTE: Internships do not count towards relevant experience requirements.
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
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.