Laboratory Quality Assurance Spec I

Baylor Scott & White Health; Dallas (TX); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Tuition reimbursement

PTO from Day 1

Job summary

Baylor Scott & White Health in Texas seeks a Lab QA Specialist 1 to ensure compliance with GLP and GMP, perform proficiency testing, review results, and maintain quality records across the lab network. The role includes preparing QA reports for management, developing and updating SOPs, conducting staff training, and coordinating audits.

Occasional travel to NTX clinics and downtown Dallas may be required. Join a mission-driven team focused on safe, accurate patient testing and regulatory

Qualifications

• Bachelor's degree or 4 years of work experience in a lab setting.
• Minimum 4 years of pre-analytical laboratory experience.
• ASCP certification or equivalent required.

Responsibilities

• Ensure GLP/GMP quality assurance per Title 21 CFR and present QA reports.
• Develop and enforce quality control procedures across sample handling.
• Monitor quality trends, investigate complaints, and implement corrective actions.
• Maintain documentation and SOP manuals; ensure availability for inspectors.
• Coordinate audits with hospital management and deliver training as needed.
• Produce ad hoc QA reports and stay current with regulatory developments.
• Communicate quality issues and improvements to management.

Skills

GLP quality

GMP quality

QA reporting

Data analysis

Regulatory knowledge

SOP writing

Audit coordination

Training delivery

Education

Bachelor's degree

ASCP certification or equivalent

Job description

About Us

Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities. Baylor Scott and White is the largest not-for-profit healthcare system in Texas that empowers you to live well.

Location BSWH Variable NTX - Sherman, Van Alstyne, Denton, Mckinney and other surrounding areas

Department Lab

Shift Monday - Friday 8am - 5pm and every 7th Saturday

Preferred Experience Must be able to travel to various clinics located throughout NTX and occasional site visit to Downtown Dallas TX. Applicant must have at least 4 years of pre-analytical experience. Mileage reimbursement is provided. Must hold ASCP certification or equivalent

Our Core Values Are

• We serve faithfully by doing what's right with a joyful heart.
• We never settle by constantly striving for better.
• We are in it together by supporting one another and those we serve.
• We make an impact by taking initiative and delivering exceptional experience.

Benefits

Our benefits are designed to help you live well no matter where you are on your journey. For full details on coverage and eligibility, visit the Baylor Scott & White Benefits Hub to explore our offerings, which may include:

• Immediate eligibility for health and welfare benefits
• 401(k) savings plan with dollar-for-dollar match up to 5%
• Tuition Reimbursement
• PTO accrual beginning Day 1

Note: Benefits may vary based upon position type and/or level.

Job Summary

The Lab QA Specialist 1 ensures compliance with institutional and federal regulations. Responsible for proficiency testing, comparing test results, reviewing results, assessing team proficiency, investigating complaints, and managing quality records. Maintains a monitoring and reporting system with documentation to ensure regulatory standards are met.

Essential Functions Of The Role

• Is accountable for GLP and GMP quality assurance as defined by Title 21 CFR. Prepares and presents QA reports to hospital management.
• Sets consistent quality assurance guidelines throughout the sample handling, data, and data reduction process.
• Sets prescribed quality control procedures and monitors remedial action.
• Examines 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 issues to hospital management regularly. Produces ad hoc reports as requested.
• Writes and maintains current manual of SOPs and making SOPs available for all related team members and external inspectors.
• Conducts quality assurance training for staff focusing on regulations, monitoring, inspections, SOPs, and other areas of quality assurance periodically.
• Stay informed about laboratory developments by reviewing literature, attending programs, and joining 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.
• Data 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 social skills.

Belonging Statement

We believe that all people should feel welcomed, valued and supported.

Qualifications

Location BSWH Variable NTX - Sherman, Van Alstyne, Denton, Mckinney and other surrounding areas

Department Lab

Shift Monday - Friday 8am - 5pm and every 7th Saturday

Preferred Experience Must be able to travel to various clinics located throughout NTX and occasional site visit to Downtown Dallas TX. Applicant must have at least 4 years of pre-analytical experience. Mileage reimbursement is provided. Must hold ASCP certification or equivalent

• EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification
• EXPERIENCE - 2 Years of Experience
• CERTIFICATION/LICENSE/REGISTRATION -

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-BB
• ASCP C
• ASCP-CG
• ASCP-CT
• ASCP-H
• ASCP-HT
• ASCP-HTL
• ASCP-M
• ASCP-MB
• ASCP-SBB
• ASCP-SC
• ASCP-SH
• ASCP-SM
• CHS-ABHI
• CHT-ABHI
• CLS
• MLS
• MLT
• MT
• SCT
• SCYM
• SMB.

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).