Quality Assurance Coordinator

Baylor St. Luke’s Medical Center is an internationally recognized leader in research and clinical excellence that has given rise to breakthroughs in cardiovascular care neuroscience oncology transplantation and more. Our team’s efforts have led to the creation of many research programs and initiatives to develop advanced treatments found nowhere else in the world. In our commitment to advancing standards in an ever-evolving healthcare environment our new McNair Campus is designed around the human experience—modeled on evidence-based practices for the safety of patients visitors staff and physicians. The 27.5-acre campus represents the future of healthcare through a transformative alliance focused on leading-edge patient care research and education. Our strong alliance with Texas Heart® Institute and Baylor College of Medicine allows us to bring our patients a powerful network of care unlike any other. Our collaboration is focused on increasing access to care through a growing network of leading specialists and revolutionizing healthcare to save lives and improve the health of the communities we serve.

JOB SUMMARY / PURPOSE
• The Quality Assurance Coordinator is responsible for ensuring all areas of the Blood Donor Center are operating in
compliance with applicable government regulations and accrediting agency standards related to the collection,
processing, testing and distribution of blood products.
• The Quality Assurance Coordinator is responsible for designing, implementing, and monitoring the Quality Assurance
program for the Blood donor Center.
• Must be able to perform duties independently.

ESSENTIAL KEY JOB RESPONSIBILITIES
1. Establish and maintain a compliance program that meets all applicable regulations and standards.
2. Oversee planning and implementation of Quality Assurance and operation projects.
3. Review current and new regulations, standards and proposed changes to determine the potential impact on current
operations and Standard Operating Procedures (SOP). Implement new and/or revised regulations and standards.
4. Review and revise current Standard Operating Procedures. Develop new Standard Operating Procedures. Ensure
compliance with current regulations and standards. Work with staff to ensure SOPs are followed, ensuring the safety of
blood products and compliance with FDA, CAP and AABB requirements both on mobile blood drives and in fixed site.
5. Oversee and coordinate regulatory and/or accreditation inspections. Work with Medical Director and department
Management to develop and submit required response(s) to regulatory agencies.
6. Develop and/or review department training programs for new and existing employees.
7. Establish and maintain departmental system for prevention, detection, investigation, tracking and corrective action of
errors.
8. Perform appropriate notification to regulatory agencies (i.e. FDA).
9. Develop and maintain processes and procedures for document control.
10. Perform QA/compliance review of records, forms and documents as needed.
11. Maintain open and positive communication with management and staff.
12. Oversee department Quality Meeting including developing and presenting quality report.

Required Education, Certifications and Experience

• Bachelor's Degree ‐ science or related field
• Medical Technologist (MT/ASCP)
• Valid Texas driver’s license

• 2 years experience in a Clinical Laboratory, Transfusion Service or Blood Center

Required Minimum Knowledge, Skills, Abilities and Training

• Knowledge of appropriate AABB and FDA requirements
• Strong interpersonal communication skills
• Ability to effectively and independently problem solve
using interpretation of regulatory guidelines and standards
• Excellent writing ability for technical, professional and other
documents
• Strong organizational skills
• Knowledge of general safety and Quality Assurance
procedures
• Ability to instruct and train on an ongoing basis
• Ability to maintain confidentiality of donor, customer,
employee and Blood Center business information
• Strong computer skills
• Effective written and verbal communication skills