Surgery Partners
Laboratory QA & QC Coordinator, Full-Time
Runs the laboratory's QA/QC program at Surgery Partners: monitoring, documentation, quality reporting, method validation, personnel competency training, and compliance with CLIA/FDA regulations and DNV/AABB standards. Daily work centers on lab testing equipment and MS Word/Excel documentation rather than software development.
- Compensation
- Not disclosed
- Location
- Addison, Texas, United States
- Work setup
- Onsite
- Seniority
- Not specified
- Employment
- Full time
- Experience
- 5+ years
- Category
- Qa
- Posted
Must have
- Bachelor's degree
- Minimum 5-10 years previous lab experience
- Laboratory Technologist Certification
- Working knowledge of MS Office
- Thorough knowledge of lab testing procedures and equipment
- Thorough knowledge of web browsers and their functionality
- Thorough knowledge of lab PT, QC, and QA program requirements and CLIA & FDA regulations and DNV & AABB standards
- Skills to initiate, expand and maintain MS Word documents
- Skills to perform laboratory testing per services provided
- Skills to organize information efficiently (files, reports, etc., paper and electronic)
- Skills to work effectively with others in a collaborative environment
- Skills to initiate, expand, and maintain MS Excel spreadsheets
- Ability to maintain confidentiality
- Ability to work efficiently with minimal oversight
- Ability to work in a fast-paced environment
Full description
GENERAL SUMMARY OF DUTIES:
The QA & QC Coordinator is responsible for the laboratory QA and QC monitoring, evaluation, documentation, and reporting program.
REQUIREMENTS:
- Bachelor’s degree required
- Minimum of 5-10 years previous lab experience required
- Laboratory Technologist Certification required
- Working knowledge of MS Office required
- Through knowledge of lab testing procedures and equipment required
- Through knowledge of web browsers and their functionality required
- Thorough knowledge of lab PT, QC, and QA program requirements and CLIA & FDA regulations and DNV & AABB standards
- Skills necessary to initiate, expand and maintain MS Word documents required
- Skills necessary to perform laboratory testing per services provided required
- Skills necessary to organize information efficiently and effectively, files, reports, etc. both paper and electronic required
- Skills necessary to work effectively with others in a collaborative environment required
- Skills necessary to initiate, expand, and maintain MS Excel spreadsheets required.
- Ability to maintain confidentiality required
- Ability to work efficiently with minimal oversight required
- Ability to work in a fast-paced environment required
ESSENTIAL FUNCTIONS:
- Maintains and establishes Quality Assessment, Quality Control, and Proficiency Testing functions, including maintaining all required documentation, records, and reports
- Resolves technical problems and ensures that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications
- Prepares quality reports to include specific monitors, including reports to QPC meetings
- Oversees and performs method validation and calibration verification studies as needed
- Analyzes and responds to client complaints, unusual incident reports and Risk Management inquires
- Assists with review of policies and procedures, performing literature searches as needed to ensure regulatory agency requirements and manufacturers’ recommendations are addressed and met
- Assists with training of testing personnel and monitoring personnel competency in all phases (pre-analytic, analytic, and post-analytic) of testing to assure the ongoing competency of all individuals who perform testing. Identifies remedial training or continuing education needed