Planet Pharma
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https://www.propharmagroup.com
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CLIA Lab QA Specialist
3401 Masons Mill Rd Bryn Athyn, PA 19009 US
Posted: 09/12/2023
2023-09-12
2023-10-19
Employment Type:
Direct Hire/Perm
Job Category: QA/Automation
Job Number: 577269
Is job remote?: No
Country: United States
Job Description
Clinical Laboratory Quality Assurance Specialists
Summary
The Clinical Laboratory Quality Assurance Specialist is responsible for ensuring compliance with regulatory standards to support laboratory quality management and to promote a culture of safety. Â Reporting to the Clinical Laboratory Manger with a dotted line to the VP of QA&RA, the Clinical Laboratory Quality Assurance Specialist ensures operational, business, outreach and outbreak response functions for the MSB Clinical laboratory.
Manages the Quality Plans for the Clinical MSB Laboratory. Coordinates all quality assessment and performance improvement activities for the Laboratory. Serves as Laboratory Compliance Officer and manages the Compliance Program to ensure compliance with all Federal, State and accreditation requirements for all laboratory operations and testing performed. Researches, monitors, updates and communicates laboratory regulatory issues.
This role reports to Customer Experience & Support Manager, Clinical Lab.
Essential Functions
Quality Assurance and Compliance •   Implement and maintain the quality assurance program to measure, assess and improve the quality of laboratory services, monitor and evaluate activities and identify risk areas through application and integration of Lean management practices.
•   Monitor internal Quality Assurance and Quality Control (QAQC ) activities, including the assistance with design of standard operating procedures, method detection limits and data quantification; assure documentation and quality assessment of laboratory functions.
•   Review quality systems for general compliance with the laboratory QA manual and certification/compliance requirements.
•   Update quality systems when necessary, working with lab management to address issues of non-compliance and to identify and implement necessary improvements.
•   Maintain familiarity with Clinical Laboratory Improvement Amendments (CLIA), ISO15189 and other state and federal regulatory guidelines.
•   Analyze and interpret national standards, guidelines, regulations and laws pertaining to clinical laboratory quality management and safety.
•   Work with staff to document regulatory compliance and use data collection tools to assess compliance with regulatory and accrediting agency standards.
•   Assist with monitoring and coordinating documentation for proficiency testing programs. Â
•   Oversee all activities for laboratory licensing and collection station licenses
•   Maintain all necessary documents and materials pertaining to licensing requirements
•   Perform internal audits in all laboratory sections against CLIA, CAP, NYS, ISO15189
•   Responsible for ensuring complete and accurate readiness for all inspections
•   Effectively coordinates Quality Management meetings and prepares agendas and minutes using standardized formats.
Safety •   Serve as Laboratory Safety Officer, providing guidance and direction to ensure that overall safety and security standards are followed and amended in response to federal and state regulations, audits, or other directives.
•   Maintain documentation and assist with implementation of staff education, including safety and security, follow-up of incident reports/corrective action reports, and quality assurance.
•   Assist during safety auditsÂ
•   Represent the Laboratory on monthly departmental safety committee meetings. Â
•   Seek funding support for both quality assurance and Laboratory System improvement activities.
•   Assist lab management to coordinate activities across the MHD program areas, such as epidemiology, emergency response, and other relevant programs.
Education and Experience •   Bachelor's degree in Biology, Chemistry, Medical Technology or a related science.
•   Minimum 1 year of experience in a clinical laboratory is required.
•   Experience in Clinical Molecular Pathology and NGS is highly preferred
•   Experience as a Generalist or in multiple CLIA defined specialties is highly preferred.
•   Prior experience in a quality related position and/or performing internal audits is a plus.
Work Environment
This job operates in an office and clinical laboratory setting.Â
Salary Range: $60-80k. Salary will be commensurate with experience.Â
Summary
The Clinical Laboratory Quality Assurance Specialist is responsible for ensuring compliance with regulatory standards to support laboratory quality management and to promote a culture of safety. Â Reporting to the Clinical Laboratory Manger with a dotted line to the VP of QA&RA, the Clinical Laboratory Quality Assurance Specialist ensures operational, business, outreach and outbreak response functions for the MSB Clinical laboratory.
Manages the Quality Plans for the Clinical MSB Laboratory. Coordinates all quality assessment and performance improvement activities for the Laboratory. Serves as Laboratory Compliance Officer and manages the Compliance Program to ensure compliance with all Federal, State and accreditation requirements for all laboratory operations and testing performed. Researches, monitors, updates and communicates laboratory regulatory issues.
This role reports to Customer Experience & Support Manager, Clinical Lab.
Essential Functions
Quality Assurance and Compliance •   Implement and maintain the quality assurance program to measure, assess and improve the quality of laboratory services, monitor and evaluate activities and identify risk areas through application and integration of Lean management practices.
•   Monitor internal Quality Assurance and Quality Control (QAQC ) activities, including the assistance with design of standard operating procedures, method detection limits and data quantification; assure documentation and quality assessment of laboratory functions.
•   Review quality systems for general compliance with the laboratory QA manual and certification/compliance requirements.
•   Update quality systems when necessary, working with lab management to address issues of non-compliance and to identify and implement necessary improvements.
•   Maintain familiarity with Clinical Laboratory Improvement Amendments (CLIA), ISO15189 and other state and federal regulatory guidelines.
•   Analyze and interpret national standards, guidelines, regulations and laws pertaining to clinical laboratory quality management and safety.
•   Work with staff to document regulatory compliance and use data collection tools to assess compliance with regulatory and accrediting agency standards.
•   Assist with monitoring and coordinating documentation for proficiency testing programs. Â
•   Oversee all activities for laboratory licensing and collection station licenses
•   Maintain all necessary documents and materials pertaining to licensing requirements
•   Perform internal audits in all laboratory sections against CLIA, CAP, NYS, ISO15189
•   Responsible for ensuring complete and accurate readiness for all inspections
•   Effectively coordinates Quality Management meetings and prepares agendas and minutes using standardized formats.
Safety •   Serve as Laboratory Safety Officer, providing guidance and direction to ensure that overall safety and security standards are followed and amended in response to federal and state regulations, audits, or other directives.
•   Maintain documentation and assist with implementation of staff education, including safety and security, follow-up of incident reports/corrective action reports, and quality assurance.
•   Assist during safety auditsÂ
•   Represent the Laboratory on monthly departmental safety committee meetings. Â
•   Seek funding support for both quality assurance and Laboratory System improvement activities.
•   Assist lab management to coordinate activities across the MHD program areas, such as epidemiology, emergency response, and other relevant programs.
Education and Experience •   Bachelor's degree in Biology, Chemistry, Medical Technology or a related science.
•   Minimum 1 year of experience in a clinical laboratory is required.
•   Experience in Clinical Molecular Pathology and NGS is highly preferred
•   Experience as a Generalist or in multiple CLIA defined specialties is highly preferred.
•   Prior experience in a quality related position and/or performing internal audits is a plus.
Work Environment
This job operates in an office and clinical laboratory setting.Â
Salary Range: $60-80k. Salary will be commensurate with experience.Â
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Ready to take your career to the next level in Bryn Athyn, Pennsylvania? This vibrant area, located in Montgomery County, offers job seekers a perfect blend of picturesque landscapes, rich history, and endless growth opportunities. Whether you're drawn to its proximity to iconic landmarks like Cairnwood Estate or the Glencairn Museum, its diverse culinary scene including the Grey Dove Grille, or the thriving arts community with places like the Glencairn Museum and the Pitcairn Performing Arts Center, Bryn Athyn has something for everyone. Consider exploring our job listings and discover why Bryn Athyn is the ideal place to build your career and immerse yourself in its unique culture and charm.
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