Lab QA Specialist 1
Location: College Station, Texas US
Requisition Number: 20002123
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 ï¿½ College Station
- Specialty/Department/Practice ï¿½ Pathology
- Shift/Schedule ï¿½ Full Time
- Benefits ï¿½ Our competitive benefits package includes*:
- 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.
2+ years of experience required
Bachelorï¿½s degree or equivalent required
American Society of Clinical Pathology (ASCP) certification required
AMT, NCA, ASCP, HEW, ABHI or AAB (LAB5) certification required
Community / Marketing Title: Lab QA Specialist 1
Location_formattedLocationLong: College Station, Texas US
CountryEEOText_Description: We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. To view the most recent EEO is the Law Poster, click here.