Shift/Schedule - Day shift 8am - 5pm

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Location - Waco TX

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JOB SUMMARY

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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.

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ESSENTIAL FUNCTIONS OF THE ROLE

\n\nIs accountable for GLP and GMP quality assurance as defined by Title 21 CFR, including preparing and presenting QA reports to hospital management.\nSets consistent quality assurance guidelines throughout the sample handling, data, and data reduction process.\nSets prescribed quality control procedures and monitors remedial action.\nExamines quality problems such as shifts and trends, and recommends corrective action.\nMonitors errors in reported results. Documents complaints, investigations of complaints, corrective actions, and resolutions.\nActs as the primary contact for FDA audits and inspections and submits responses to external inspections.\nSummarizes audit findings for management and makes operational and training improvements based on these needs.\nMaintains a system for reporting quality assurance and compliance issue to hospital management on a regular basis. Produces ad hoc reports as requested.\nWrites and maintains current manual of SOPs and making SOPs available for all related team members and external inspectors.\nConducts quality assurance training for staff focusing on regulations, monitoring, inspections, SOPs, and other areas of quality assurance periodically.\nMaintains knowledge of developments in laboratories by reviewing current literature, attending educational programs, and participating in the activities of professional organizations.\nPerforms special quality assurance projects as requested by management or hospital administration.\nPerforms all delegated functions as defined by facility CLIA Director.\n\n

KEY SUCCESS FACTORS

\n\nKnowledge of laboratory regulations, protocols and procedures.\nData and critical thinking abilities.\nAbility to comprehend and communicate instructions.\nAbility to perform laboratory protocols and procedures.\nSkill in the use of computers and related software applications.\nKnowledge of safety and infection control standards.\nAbility to work in a team environment.\nProvides training and opportunities for continuing education.\nEffective leadership and social skills.\n\n

BENEFITS

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Our competitive benefits package includes the following

\n\nImmediate eligibility for health and welfare benefits\n401(k) savings plan with dollar-for-dollar match up to 5%\nTuition Reimbursement\nPTO accrual beginning Day 1\n\n

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

QUALIFICATIONS

\n\n EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification\n EXPERIENCE - 2 Years of Experience\n 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:\n\n

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): .