HEALTHTRACKRX INC
Oversees the day-to-day technical aspects of a CAP accredited Molecular Diagnostics Lab, ensuring compliance with CAP and CLIA regulations. Responsible for technical testing, personnel competency, troubleshooting, protocol development, and maintaining quality and safety standards within the lab.
Key Responsibilities
- • Responsible for the overall administration of the technical laboratory procedures and personnel
- • Create and guide implementation of new SOPs to increase efficiency and reduce errors in conjunction to reviewing, and providing continual education and training to supervisors and managers so they can do the same for their personnel
- • Coordinate with the Lab Operations and Compliance / Quality department that SOPs are compliant with the most up-to-date accrediting agencies requirements including
- • Document validations of new protocols
- • Create/ revise SOPs for new protocols
- • Synchronize with the Company Lab Safety Office and Lab Safety Operations Team to ensure all laboratory personnel are notified of all lab safety requirements in addition to appointing internal technical lab safety officers to monitor safety of each shift/ area of the technical lab atmosphere
- • Head lab initiatives to increase the overall scientific knowledge of the procedures used in the lab in conjunction to ensure all existing and incoming lab personnel are trained and kept abreast of laboratory safety protocols and initiatives
- • Continuously monitor and develop workflow process as need to ensure timely turn around, efficacy, and quality specimen processing in the lab.
- • Document quality assessment of all laboratory employees in compliance with CAP, and CLIA.
- • Coordinates with regulatory authorities, such as CAP and CLIA, as appropriate.
- • Provide continuing education and training for managers and supervisors
Required
- • Doctoral degree in chemical, physical, biological or clinical laboratory science from an accredited institution
- • Ability to provide technical oversight for laboratory personnel and program managers
- • Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
- • Ability to think strategically to address internal and external problems
- • Superior communication skills and ability to effectively communicate with stakeholders at many levels within the organization
- • In depth knowledge of CAP and CLIA regulations
- • 3 years’ experience supervising a laboratory section such as anatomic pathology or clinical pathology, of a clinical or public health laboratory
- • Experience in lab administration
- • Certified by and continue to be certified by a board approved by HHS. The current approve boards are the following: ABB – American Board of Bioanalysis, ABMM – American Board of Medical Microbiology
Job Summary:
Oversees the day-to-day technical aspects of a CAP accredited Molecular Diagnostics Lab. The Molecular Diagnostics Lab Operations will be defined as all operations within the Molecular Diagnostics Lab. Responsible for the overall technical testing lab, including the employment of personnel who are competent to perform testing, troubleshoot testing issues, develop protocols as accurately and proficiently as possible, and for assuring compliance with applicable CAP and CLIA regulations.
Essential Responsibilities/Duties:
- Responsible for the overall administration of the technical laboratory procedures and personnel
- Create and guide implementation of new SOPs to increase efficiency and reduce errors in conjunction to reviewing, and providing continual education and training to supervisors and managers so they can do the same for their personnel
- Coordinate with the Lab Operations and Compliance / Quality department that SOPs are compliant with the most up-to- date accrediting agencies requirements including
- Document validations of new protocols
- Create/ revise SOPs for new protocols
- Synchronize with the Company Lab Safety Office and Lab Safety Operations Team to ensure all laboratory personnel are notified of all lab safety requirements in addition to appointing internal technical lab safety officers to monitor safety of each shift/ area of the technical lab atmosphere
- Head lab initiatives to increase the overall scientific knowledge of the procedures used in the lab in conjunction to ensure all existing and incoming lab personnel are trained and kept abreast of laboratory safety protocols and initiatives
- Continuously monitor and develop workflow process as need to ensure timely turn around, efficacy, and quality specimen processing in the lab.
- Document quality assessment of all laboratory employees in compliance with CAP, and CLIA.
- Coordinates with regulatory authorities, such as CAP and CLIA, as appropriate.
- Provide continuing education and training for managers and supervisors
Qualifications:
Education –
- Doctoral degree in chemical, physical, biological or clinical laboratory science from an accredited institution
Competencies/Skills –
- Ability to provide technical oversight for laboratory personnel and program managers
- Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
- Ability to think strategically to address internal and external problems
- Superior communication skills and ability to effectively communicate with stakeholders at many levels within the organization
- In depth knowledge of CAP and CLIA regulations
Experience –
- 3 years’ experience supervising a laboratory section such as anatomic pathology or clinical pathology, of a clinical or public health laboratory
- Experience in lab administration
Certifications/Licenses –
- Certified by and continue to be certified by a board approved by HHS. The current approve boards are the following:
- ABB – American Board of Bioanalysis
- ABMM – American Board of Medical Microbiology
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