What are the responsibilities and job description for the Confirmations Manager position at Cordant Health Solutions?
We are seeking an experienced Laboratory Confirmations Manager to join our team in Indianapolis, IN. The position is responsible for the management of the confirmations departments including sample preparation and confirmatory analysis via LC/MS/MS of urine and oral fluid specimens for drugs of abuse in a forensic environment. This includes the management of people, processes, inventory, and machines. Desired are strong skills in process improvement, problem solving, enforcement of and compliance with policies and procedures, communication and reporting, record keeping and other laboratory operations.
Role Responsibilities
Sample handling and Liquid chromatography tandem-mass spectrometry (LC-MS-MS) analyses that are in accordance with lab standard practices
Oversite of confirmation result certification
Applies knowledge and skills to produce quality work and facilitate meeting turnaround time goals (TAT) goals
Liquid chromatography tandem-mass spectrometry (LC-MS-MS) analysis of biological samples
New employee training and cross-training is completed and is in compliance with all lab rules, regulations, standard work, standard operating procedures and associated guidelines.
Ensures all methods and validations meet with certification and compliance requirements under the direct leadership of the lab director and lab management
Collaborates with leadership to solve work-related problems within or between departments and sites, answering questions and resolving issues daily
Allocate work schedules, assignments, and analytical resources to meet production goals, respond to fluctuating workloads, and improve quality and productivity of laboratory operations
Read and maintain applicable department’s: standard operation procedures in accordance with best practice, laboratory guidelines and best practices in coordination with the Lab Scientific Director and the General Manager, Indianapolis Laboratory
Enforce compliance of all policies, procedures, standards, guidelines, and best practices for: Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP), safety, environmental, hazardous materials, equipment, and security guidelines
Maintain accountability for attendance, productivity, training, and incidents with analytical staff
Performs employee appraisals
Approves all timecards weekly and PTO requests
Ensure that all work is complete, accurate and meets our high-quality standards
Determines proper levels of materials and makes sure inventory is maintained to meet anticipated work volumes. Ensures weekly and monthly counts are performed and alerts management to critical inventory item shortages.
Acts as an Information Technology (IT) contact for lab issues, system upgrades and new machine installation. Provides technical support for LIMs and software testing.
Actively participates in all internal inspections. Technical resource and participant for external audits and inspections. Schedules staff to ensure optimum production and work coverage.
Provides support for team leads, assuring that personnel levels are appropriate for continuous workflow while maintaining first pass-through quality.
Prepares justification for increased workforce requirements.
Responsible for running daily reports and investigating misplaced samples
Reviews monthly QC and corrective actions, identifying trends for follow up
Works closely with QA manager to complete monthly reviews of QC, reagent prep, maintenance logs, equipment logs, etc. for submission to the Scientific Director
In conjunction with the Scientific Director, assures that all methods and validations are complete and meet certification and compliance requirements.
Ensures all scheduled instrument maintenance is completed on time and acts as additional liaison to service vendors
Responsible to maintain all safeguards as it pertains to Protected health information (PHI)
Education and Experience
A Bachelor’s degree in a chemical, physical, or biological science; to be evaluated with 5 years laboratory experience
Master's Degree in above fields with 3 years of laboratory experience
Doctoral Degree in above fields with 2 years of laboratory experience
Previous supervisory and/or training experience, >2 years
Desired Additional Skills
Experience with sample preparation techniques and LCMSMS platforms
Familiarity with CLIA and CAP accreditation requirements
Excel, Word, Bower BI, LIMS software proficiency
Role Responsibilities
Sample handling and Liquid chromatography tandem-mass spectrometry (LC-MS-MS) analyses that are in accordance with lab standard practices
Oversite of confirmation result certification
Applies knowledge and skills to produce quality work and facilitate meeting turnaround time goals (TAT) goals
Liquid chromatography tandem-mass spectrometry (LC-MS-MS) analysis of biological samples
New employee training and cross-training is completed and is in compliance with all lab rules, regulations, standard work, standard operating procedures and associated guidelines.
Ensures all methods and validations meet with certification and compliance requirements under the direct leadership of the lab director and lab management
Collaborates with leadership to solve work-related problems within or between departments and sites, answering questions and resolving issues daily
Allocate work schedules, assignments, and analytical resources to meet production goals, respond to fluctuating workloads, and improve quality and productivity of laboratory operations
Read and maintain applicable department’s: standard operation procedures in accordance with best practice, laboratory guidelines and best practices in coordination with the Lab Scientific Director and the General Manager, Indianapolis Laboratory
Enforce compliance of all policies, procedures, standards, guidelines, and best practices for: Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP), safety, environmental, hazardous materials, equipment, and security guidelines
Maintain accountability for attendance, productivity, training, and incidents with analytical staff
Performs employee appraisals
Approves all timecards weekly and PTO requests
Ensure that all work is complete, accurate and meets our high-quality standards
Determines proper levels of materials and makes sure inventory is maintained to meet anticipated work volumes. Ensures weekly and monthly counts are performed and alerts management to critical inventory item shortages.
Acts as an Information Technology (IT) contact for lab issues, system upgrades and new machine installation. Provides technical support for LIMs and software testing.
Actively participates in all internal inspections. Technical resource and participant for external audits and inspections. Schedules staff to ensure optimum production and work coverage.
Provides support for team leads, assuring that personnel levels are appropriate for continuous workflow while maintaining first pass-through quality.
Prepares justification for increased workforce requirements.
Responsible for running daily reports and investigating misplaced samples
Reviews monthly QC and corrective actions, identifying trends for follow up
Works closely with QA manager to complete monthly reviews of QC, reagent prep, maintenance logs, equipment logs, etc. for submission to the Scientific Director
In conjunction with the Scientific Director, assures that all methods and validations are complete and meet certification and compliance requirements.
Ensures all scheduled instrument maintenance is completed on time and acts as additional liaison to service vendors
Responsible to maintain all safeguards as it pertains to Protected health information (PHI)
Education and Experience
A Bachelor’s degree in a chemical, physical, or biological science; to be evaluated with 5 years laboratory experience
Master's Degree in above fields with 3 years of laboratory experience
Doctoral Degree in above fields with 2 years of laboratory experience
Previous supervisory and/or training experience, >2 years
Desired Additional Skills
Experience with sample preparation techniques and LCMSMS platforms
Familiarity with CLIA and CAP accreditation requirements
Excel, Word, Bower BI, LIMS software proficiency
