The Lab QA Specialist 1 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. Maintains a monitoring and reporting system that includes appropriate documentation to support that regulatory standards are met.
ESSENTIAL FUNCTIONS OF THE ROLE
Is responsible for GLP and GMP quality assurance as defined by Title 21 CFR, including preparing and presenting QA reports to hospital management.
Sets consistent quality assurance guidelines throughout the sample handling, analytical, and data reduction process. Sets prescribed quality control procedures and monitors remedial action. Analyzes quality problems such as shifts and trends, and recommends corrective action. Monitors errors in reported results. Documents complaints, investigations of complaints, corrective actions, and resolutions.
Acts as the primary contact for FDA audits and inspections and submits responses to external inspections.
Summarizes audit findings for management and makes operational and training improvements based on these needs.
Maintains a system for reporting quality assurance and compliance issue to hospital management on a regular basis. Produces ad hoc reports as requested.
Writes and maintains current manual of SOPs and making SOPs available for all related personnel and external inspectors.
Conducts quality assurance training for staff focusing on regulations, monitoring, inspections, SOPs, and other areas of quality assurance periodically.
Maintains knowledge of developments in laboratories by reviewing current literature, attending educational programs, and participating in the activities of professional organizations.
Performs special quality assurance projects as requested by management or hospital administration.
Performs all delegated functions as defined by facility CLIA Director.
KEY SUCCESS FACTORS
Knowledge of laboratory regulations, protocols and procedures.
Analytical and critical thinking abilities.
Ability to comprehend and communicate instructions.
Ability to perform laboratory protocols and procedures.
Skill in the use of computers and related software applications.
Knowledge of safety and infection control standards.
Ability to work in a team environment.
Provides training and opportunities for continuing education.
Effective leadership and interpersonal skills.
Our competitive benefits package includes the following
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 - Bachelor's or 4 years of work experience above the minimum qualification
EXPERIENCE - 2 Years of Experience
ASCP-BloodBanking Technologist (ASCP-BB), ASCP-Chemistry Technologist (ASCP-C), ASCP-Cytogenetics Technologist (ASCP-CG), ASCP-Cytologist (ASCP-CT), ASCP-Hematology Technologist (ASCP-H), ASCP-Histotechnician (ASCP-HT), ASCP-Histotechnologist (ASCP-HTL), ASCP-Microbiology Technologist (ASCP-M), Molecular Biology Technologist (ASCP-MB), ASCP-Blood Banking Specialist (ASCP-SBB), ASCP-Chemistry Specialist (ASCP-SC): Must have one of the following:
ASCP-Hematology Specialist (ASCP-SH), ASCP-Microbiology Specialist (ASCP-SM), Cert Histocompatibility Spec (CHS-ABHI), Cert Histocompatibility Techno (CHT-ABHI), Clinical Laboratory Scientist (CLS), Medical Laboratory Scientist (MLS), Medical Laboratory Technician (MLT), Medical Technologist (MT), Specialist in Cytology-ASCP (SCT), Specialist in Cytometry-ASCP (SCYM), Molecular Biology Spec-ASCP (SMB): .
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!