Senior Coordinator, Research Operations - Quality Assurance jobs in United States
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Baylor College of Medicine · 20 hours ago

Senior Coordinator, Research Operations - Quality Assurance

Baylor College of Medicine is recognized as one of the world’s leading vaccine development centers. They are seeking a Senior Coordinator, Research Operations Specialist to support vaccine initiatives within the Section of Pediatric Tropical Medicine. This role is responsible for coordinating quality assurance, regulatory research, and administrative projects, ensuring compliance and operational excellence.

EducationHigher EducationPharmaceutical
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Responsibilities

Organize information into spreadsheet format from data collection
Prepare document templates using Adobe Acrobat, MS Word and Excel
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

Qualification

Quality management systemDocument controlGxPs knowledgeMS Word proficiencyMS Excel proficiencyAdobe proficiencyResourcefulnessMultitaskingDetail-orientedWritten communicationOral communicationProblem solvingOrganizational skills

Required

High School diploma or GED
Four years of relevant experience

Preferred

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

Company

Baylor College of Medicine

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Baylor College of Medicine, located in the Texas Medical Center, is a health sciences university located in Houston, Texas

Funding

Current Stage
Late Stage
Total Funding
$10.85M
Key Investors
National Human Genome Research InstituteNational Heart, Lung and Blood InstituteCancer Prevention and Research Institute of Texas
2024-12-05Grant· $3.5M
2024-09-26Grant
2024-09-19Grant

Leadership Team

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Paul Klotman
President, CEO and Executive Dean
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Peggy Smith
Professir and CEO. Teen Health Clinics
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Company data provided by crunchbase