The Lab QA Specialist I maintains compliance with both institutional and federal regulatory requirements. Responsible for proficiency testing, comparison of test results, review of results, assessment of personnel competency, complaint investigation, and quality records. The Specialist maintains a monitoring and reporting system that includes appropriate documentation to support that regulatory standards meet.
Below are the essential functions for the role.
Responsible for GLP and GMP quality assurance as defined by Title 21 CFR, including preparing and presenting QA reports to hospital management.
Provide quality assurance guidelines throughout the sample handling, analytical, and data reduction process and set prescribed quality control procedures.
Analyze quality problems such as shifts and trends, and recommends corrective action; monitor errors in reported results and documents complaints, investigations of complaints, corrective actions, and resolutions.
Act as the primary contact for FDA audits and inspections and submits responses to external inspections.
Summarize audit findings for management and make operational and training improvements.
Write and maintain current manual of SOPs and make SOPs available for all related personnel and external inspectors.
Conduct quality assurance training for staff on regulations, monitoring, inspections, and SOPs.
The ideal candidate must have knowledge of laboratory regulations, safety and infection, protocols and procedures. The ideal candidate must have critical thinking, communication, computer software, leadership and interpersonal skills and the ability to work in a team environment. ASCP (MT/CLS/MLS/MLT), or AMT (MT/CLS/MLS/MLT), or HEW (MT/CLS/MLS), or AAB (MT/CLS/MLS/MLT), or ABHI (CHT/CHS), or ASCP Scientist/Specialist (BB, C, H, M, MB, SBB, SC, SH, SM) required.
Location/Facility – Baylor Scott and White - Northwest Dallas region
Specialty/Department/Practice – Quality Assurance
Shift/Schedule – Mon-Fri 8am-5pm (Standard Business Hours) *Required to be in clinic with the region supported
Immediate eligibility for health and welfare benefits
401(k) savings plan with dollar-for-dollar match up to 5%
PTO accrual beginning Day 1
*Note: Benefits may vary based upon position type and/or level.
- EDUCATION - Bachelors or Equivalent Exp
- EXPERIENCE - A minimum of 2 years experience required
- CERTIFICATION/LICENSE/REGISTRATION - Amer Society of Cln Pathology (ASCP)
Internal Number: 20011647
About Baylor Scott & White Health
Baylor Scott & White Health (BSWH) is the largest not-for-profit health care system in Texas and one of the largest in the United States. With a commitment to and a track record of innovation, collaboration, integrity and compassion for the patient, BSWH stands to be one of the nation’s exemplary health care organizations. Our mission is to serve all people by providing personalized health and wellness through exemplary care, education and research as a Christian ministry of healing. Joining our team is not just accepting a job, it’s accepting a calling!