Morristown, New Jersey
Houston, Texas
Essex County, Massachusetts
Long Beach, California, California
Carmel, Indiana
Nashville, Tennessee
Posted: 20-Dec-24
Location: Waco, Texas
Categories:
Internal Number: 24020459
JOB SUMMARY
The Lab QA Specialist 1 maintains compliance with both institutional and federal regulatory requirements. Accountable for proficiency testing, comparison of test results, review of results, assessment of team proficiency, complaint investigation, and quality records. Maintains a monitoring and reporting system that includes appropriate documentation to help that regulatory standards are met.
ESSENTIAL FUNCTIONS OF THE ROLE
- Is accountable 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, 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 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 team members 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.
- 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.
BENEFITS
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%
- Tuition Reimbursement
- PTO accrual beginning Day 1
Note: Benefits may vary based on position type and/or level
QUALIFICATIONS
- 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): .