Senior Research Quality Assurance Associate
Baylor College of Medicine
Houston, TX
Job posting number: #7107786 (Ref:12654-en_US)
Posted: August 11, 2022
Application Deadline: Open Until Filled
Job Description
Summary
The Senior Research Quality Assurance Associate monitors research activities to ensure compliance with relevant local, federal, and state regulatory and institutional policies in support of the Department of Pediatrics, Division of Tropical Medicine at Baylor College of Medicine vaccine development initiatives. The position collaborates with members of the quality assurance, quality control and regulatory affairs team and works closely with cross functional units within the Texas Children's Hospital Center for Vaccine Development (TCH-CVD) and its collaborating partners. The Senior QA Associate is responsible for the oversight and improvement of the existing quality system and maintains a continuous working knowledge of cGXPs to ensure a constant state of inspection readiness.
Job Duties
- Assess the quality, preclinical, manufacturing and testing documentation in support of the quality system
- Maintain shipments, inventory, stability, audit and personnel training files
- Participate in/lead vendor audits and monitor vendors for re-qualification
- Conduct internal and external audit
- Manage non-conformances to ensure that corrective and preventative actions are appropriate
- Assess and approve raw materials
- Participate in teams involved with product and process development
- Maintain the change control system
- Assist with equipment maintenance, calibrations and preventive maintenance
- Review laboratory notebook studies
- Write, revise and approve SOPs
- Write, revise and approve Safety Data Sheets
- Prepare, approve and maintain Certificate of Analysis/Certificate of Conformance
- Prepare, approve and maintain stability testing results of regulated materials
- Plan the Annual GMP training for team members
Minimum Qualifications
- Bachelor's degree.
- Four years of relevant experience.
Preferred Qualifications
- Bachelor's in science or health related field
- Familiar with GMP and GLP regulations
- Experience with quality systems
- Some background in biologics and/or pharmaceutical development, manufacturing, quality testing and audit qualification
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
12654
CA; SN
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. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.
