State of Maine
Quality assurance officer
State of Maine, Augusta, Maine, us, 04338
Department of Health and Human Services (DHHS)
Opening Date: September 10, 2024
Closing Date: September 24, 2024
Job Class Code:
9248Grade:
04-26 (Pro / Tech)Salary:
$56,264.00 - $78,998.40 per year
Position Number:
2000-2952
Location:
This is a full-time position located in Augusta. This opportunity allows partial telework with management approval.The selected candidate will be responsible for assisting in the continuing development of the laboratory quality assurance program for the Clinical Microbiology Department, providing training, performing audits, investigating, and documenting performance issues, and evaluating the effectiveness of corrective actions to improve testing services as required by Clinical Laboratory Improvement Amendments (CLIA), federal CDC, Maine CDC, and the Health and Environmental Testing Laboratory (HETL).The selected candidate will carry out the duties as the Federal CDC’s Laboratory Response Network (LRN) Laboratory Program Advisor. This is a leadership position requiring extensive interactions with private and federal entities such as hospital laboratories and the federal CDC. General duties include, but are not limited to, conducting periodic state-wide visits to hospital laboratories, and performing assessments of testing capability and capacity. This is to ensure that hospital laboratories are up to date on the most recent analytical methods used in the isolation and identification of agents of bioterrorism. This position also ensures that the HETL possesses the analytical capability to test for agents of bioterrorism, to interact with the CDC and LRN laboratories and to ensure compliance with responsible sections of the Federal Select Agent Rules 7 C.F.R. Part 331: Agriculture · 9 C.F.R. Part 121: Animals and Animal Products · 42 C.F.R. Part 73: Public Health.Core ResponsibilitiesAs a key member of the HETL team, your core responsibilities will include:Participation in annual biosafety and chemical safety trainingsOversight of quality assurance and quality control measures in the Clinical microbiology section within HETLReview of CLIA guidelines to assure laboratory complianceReview of IQCP/QA/QC metrics for all standard operating procedures (SOPs)Oversight of CLIA competencies and proficiencies to assure annual completionPreparation of all documents for CLIA inspectionsDeveloping and coordinating monthly QA Committee meetings with clinical and LRN StaffDeveloping and coordinating quarterly meetings with the Epi-Lab Work GroupDeveloping, implementing, and coordinating the internal audit program to document program effectivenessLeading external third-party audits for CLIA, EPA, OSHA, DEP, etc.Communicating HETL policies for: sample collection, emergency authorizations, and testing updates to all clinical laboratories within the StateDeveloping, implementing, and coordinating a non-conformance program through quality notification forms (QNFs) and corrective actions reports (CARs)Develops and conducts internal auditsManaging PJF, RFP, and bidding process for calibration services, document management software, temperature monitoring software, and other quality servicesCoordination with the Laboratory Safety OfficerDeveloping, reviewing, and approval of policies, manuals, standard operating procedures, and forms for HETL and Sentinel LaboratoriesCollaboration with staff in the Maine CDC and other state agencies on emergency preparednessParticipation in the Federal CDC LRN-B networkDeveloping an integrated system of public health, hospital, and independent laboratories for preparedness and detection of bioterrorism events and diseases of public health importanceProviding coordination of periodic statewide on-site visits and training to Sentinel laboratories as required by the Federal CDC and LRN-BOrganizing meetings, communication, and coordination between the HETL and Sentinel laboratoriesProviding design evaluation of the Sentinel laboratory facilities and recommendation for changes, as neededManaging and coordination of an outreach program with all Sentinel laboratories for sample submissions, workflows, and post-analytical processes for all patient testingProviding assessment and evaluation of Sentinel laboratory capability and capacity to facilitate LRN responseManaging proficiency testing for CDC assessment of Maine's capability to monitor for biological agents of Weapons of Mass Destruction (WMD)MINIMUM QUALIFICATIONS:
(Entry level knowledges, skills, and/or abilities may be acquired through, BUT ARE NOT LIMITED TO the following coursework/training and/or experience).A Bachelor’s Degree in Medical Technology or chemical, physical, or directly related life science and six (6) years of clinical laboratory experience. Comparable experience may be substituted for education on a year-for-year basis.Preferred candidates will also have:Excellent oral and written communication skillsProfessional certifications such as ASCP, MLT, or MTKnowledge or experience with federal laboratory accreditation programs such as CLIA or CAPKnowledge of a laboratory information system (StarLims)Extensive technical knowledge of serology, bacteriology, virology, molecular, biology, and histology laboratory methodsAbility to establish and maintain effective working relationships with a diverse group of internal and external partnersAbility to work with managers and staff to identify training needs and research information on training/meeting opportunities, and to provide outreach materials for systems in need of technical assistanceAbility to visit all Sentinel Laboratories in MaineAbility to troubleshoot and problem solve when challenges ariseAbility to multi-task and re-prioritize on a daily basis to meet deadlinesKnowledge of and experience with website development and maintenanceThinking about applying?Research shows that people from historically excluded communities tend to apply to jobs only when they check every box in the posting. If you’re currently reading this and hesitating to apply for that reason, we encourage you to go for it! Let us know how your lived experience and passion set you apart.Agency information:The Department of Health and Human Services (DHHS) is dedicated to promoting health, safety, resilience, and opportunity for Maine people. The Department provides health and social services to approximately a third of the State's population, including children, families, older Mainers, and individuals with disabilities, mental illness, and substance use disorders. The Department also promotes public health, operates two state psychiatric hospitals, and provides oversight to health care providers.The mission for the Maine Center for Disease Control and Prevention (Maine CDC), within which this position is located, is to develop and deliver services to preserve, protect, and promote the health and well-being of the citizens of Maine.Application Information:For additional information about this position
please contact Melissa Chisholm, Senior Scientist, at (207) 215-6418.To apply , please upload a resume and cover letter with your application. Please submit all documents or files in PDF format.To request a paper application, please contact Ashley.Smith@Maine.gov.Benefits of working for the State of Maine:No matter where you work across Maine state government, you find employees who embody our state motto—"Dirigo" or "I lead"—as they provide essential services to Mainers every day. We believe in supporting our workforce's health and wellbeing with a valuable total compensation package, including:Work-Life Fit
– Rest is essential. Take time for yourself using
13 paid holidays ,
12 days of sick leave , and
3+ weeks of vacation leave
annually. Vacation leave accrual increases with years of service, and overtime-exempt employees receive personal leave.Health Insurance Coverage
– The State of Maine pays
85%-95%
of employee-only premiums ($11,196.96 - $12,514.32 annual value), depending on salary. Use this chart to find the premium costs for you and your family, including the percentage of dependent coverage paid by the State.Dental Insurance
– The State of Maine pays 100% of employee-only dental premiums ($387.92 annual value).Retirement Plan
– The State contributes the equivalent of 13.29% of the employee's pay towards the Maine Public Employees Retirement System (MainePERS).Parental leave
is one of the most important benefits for any working parent. All employees who are welcoming a child—including fathers and adoptive parents—receive
six weeks of fully paid parental leave . Additional, unpaid leave may also be available, under the Family and Medical Leave Act.
State employees are eligible for an extensive and highly competitive benefits package, covering many aspects of wellness. Learn about
additional wellness benefits
for State employees from the Office of Employee Health and Wellness.
There's a job and then there's purposeful, transformative work. Our aim is to create a workplace where you can learn, grow, and continuously refine your skills. Applicants demonstrate job requirements in differing ways, and we appreciate that many skills and backgrounds can make people successful in this role.As an Equal Opportunity employer, Maine State Government embraces a culture of respect and awareness. We are committed to creating a strong sense of belonging for all team members, and our process ensures an inclusive environment to applicants of all backgrounds including diverse race, color, sex, sexual orientation or gender identity, physical or mental disability, religion, age, ancestry, national origin, familial status or genetics.If you’re looking for a great next step, and want to feel good about what you do, we’d love to hear from you. Please note reasonable accommodations are provided to qualified individuals with disabilities upon request.
#J-18808-Ljbffr
Opening Date: September 10, 2024
Closing Date: September 24, 2024
Job Class Code:
9248Grade:
04-26 (Pro / Tech)Salary:
$56,264.00 - $78,998.40 per year
Position Number:
2000-2952
Location:
This is a full-time position located in Augusta. This opportunity allows partial telework with management approval.The selected candidate will be responsible for assisting in the continuing development of the laboratory quality assurance program for the Clinical Microbiology Department, providing training, performing audits, investigating, and documenting performance issues, and evaluating the effectiveness of corrective actions to improve testing services as required by Clinical Laboratory Improvement Amendments (CLIA), federal CDC, Maine CDC, and the Health and Environmental Testing Laboratory (HETL).The selected candidate will carry out the duties as the Federal CDC’s Laboratory Response Network (LRN) Laboratory Program Advisor. This is a leadership position requiring extensive interactions with private and federal entities such as hospital laboratories and the federal CDC. General duties include, but are not limited to, conducting periodic state-wide visits to hospital laboratories, and performing assessments of testing capability and capacity. This is to ensure that hospital laboratories are up to date on the most recent analytical methods used in the isolation and identification of agents of bioterrorism. This position also ensures that the HETL possesses the analytical capability to test for agents of bioterrorism, to interact with the CDC and LRN laboratories and to ensure compliance with responsible sections of the Federal Select Agent Rules 7 C.F.R. Part 331: Agriculture · 9 C.F.R. Part 121: Animals and Animal Products · 42 C.F.R. Part 73: Public Health.Core ResponsibilitiesAs a key member of the HETL team, your core responsibilities will include:Participation in annual biosafety and chemical safety trainingsOversight of quality assurance and quality control measures in the Clinical microbiology section within HETLReview of CLIA guidelines to assure laboratory complianceReview of IQCP/QA/QC metrics for all standard operating procedures (SOPs)Oversight of CLIA competencies and proficiencies to assure annual completionPreparation of all documents for CLIA inspectionsDeveloping and coordinating monthly QA Committee meetings with clinical and LRN StaffDeveloping and coordinating quarterly meetings with the Epi-Lab Work GroupDeveloping, implementing, and coordinating the internal audit program to document program effectivenessLeading external third-party audits for CLIA, EPA, OSHA, DEP, etc.Communicating HETL policies for: sample collection, emergency authorizations, and testing updates to all clinical laboratories within the StateDeveloping, implementing, and coordinating a non-conformance program through quality notification forms (QNFs) and corrective actions reports (CARs)Develops and conducts internal auditsManaging PJF, RFP, and bidding process for calibration services, document management software, temperature monitoring software, and other quality servicesCoordination with the Laboratory Safety OfficerDeveloping, reviewing, and approval of policies, manuals, standard operating procedures, and forms for HETL and Sentinel LaboratoriesCollaboration with staff in the Maine CDC and other state agencies on emergency preparednessParticipation in the Federal CDC LRN-B networkDeveloping an integrated system of public health, hospital, and independent laboratories for preparedness and detection of bioterrorism events and diseases of public health importanceProviding coordination of periodic statewide on-site visits and training to Sentinel laboratories as required by the Federal CDC and LRN-BOrganizing meetings, communication, and coordination between the HETL and Sentinel laboratoriesProviding design evaluation of the Sentinel laboratory facilities and recommendation for changes, as neededManaging and coordination of an outreach program with all Sentinel laboratories for sample submissions, workflows, and post-analytical processes for all patient testingProviding assessment and evaluation of Sentinel laboratory capability and capacity to facilitate LRN responseManaging proficiency testing for CDC assessment of Maine's capability to monitor for biological agents of Weapons of Mass Destruction (WMD)MINIMUM QUALIFICATIONS:
(Entry level knowledges, skills, and/or abilities may be acquired through, BUT ARE NOT LIMITED TO the following coursework/training and/or experience).A Bachelor’s Degree in Medical Technology or chemical, physical, or directly related life science and six (6) years of clinical laboratory experience. Comparable experience may be substituted for education on a year-for-year basis.Preferred candidates will also have:Excellent oral and written communication skillsProfessional certifications such as ASCP, MLT, or MTKnowledge or experience with federal laboratory accreditation programs such as CLIA or CAPKnowledge of a laboratory information system (StarLims)Extensive technical knowledge of serology, bacteriology, virology, molecular, biology, and histology laboratory methodsAbility to establish and maintain effective working relationships with a diverse group of internal and external partnersAbility to work with managers and staff to identify training needs and research information on training/meeting opportunities, and to provide outreach materials for systems in need of technical assistanceAbility to visit all Sentinel Laboratories in MaineAbility to troubleshoot and problem solve when challenges ariseAbility to multi-task and re-prioritize on a daily basis to meet deadlinesKnowledge of and experience with website development and maintenanceThinking about applying?Research shows that people from historically excluded communities tend to apply to jobs only when they check every box in the posting. If you’re currently reading this and hesitating to apply for that reason, we encourage you to go for it! Let us know how your lived experience and passion set you apart.Agency information:The Department of Health and Human Services (DHHS) is dedicated to promoting health, safety, resilience, and opportunity for Maine people. The Department provides health and social services to approximately a third of the State's population, including children, families, older Mainers, and individuals with disabilities, mental illness, and substance use disorders. The Department also promotes public health, operates two state psychiatric hospitals, and provides oversight to health care providers.The mission for the Maine Center for Disease Control and Prevention (Maine CDC), within which this position is located, is to develop and deliver services to preserve, protect, and promote the health and well-being of the citizens of Maine.Application Information:For additional information about this position
please contact Melissa Chisholm, Senior Scientist, at (207) 215-6418.To apply , please upload a resume and cover letter with your application. Please submit all documents or files in PDF format.To request a paper application, please contact Ashley.Smith@Maine.gov.Benefits of working for the State of Maine:No matter where you work across Maine state government, you find employees who embody our state motto—"Dirigo" or "I lead"—as they provide essential services to Mainers every day. We believe in supporting our workforce's health and wellbeing with a valuable total compensation package, including:Work-Life Fit
– Rest is essential. Take time for yourself using
13 paid holidays ,
12 days of sick leave , and
3+ weeks of vacation leave
annually. Vacation leave accrual increases with years of service, and overtime-exempt employees receive personal leave.Health Insurance Coverage
– The State of Maine pays
85%-95%
of employee-only premiums ($11,196.96 - $12,514.32 annual value), depending on salary. Use this chart to find the premium costs for you and your family, including the percentage of dependent coverage paid by the State.Dental Insurance
– The State of Maine pays 100% of employee-only dental premiums ($387.92 annual value).Retirement Plan
– The State contributes the equivalent of 13.29% of the employee's pay towards the Maine Public Employees Retirement System (MainePERS).Parental leave
is one of the most important benefits for any working parent. All employees who are welcoming a child—including fathers and adoptive parents—receive
six weeks of fully paid parental leave . Additional, unpaid leave may also be available, under the Family and Medical Leave Act.
State employees are eligible for an extensive and highly competitive benefits package, covering many aspects of wellness. Learn about
additional wellness benefits
for State employees from the Office of Employee Health and Wellness.
There's a job and then there's purposeful, transformative work. Our aim is to create a workplace where you can learn, grow, and continuously refine your skills. Applicants demonstrate job requirements in differing ways, and we appreciate that many skills and backgrounds can make people successful in this role.As an Equal Opportunity employer, Maine State Government embraces a culture of respect and awareness. We are committed to creating a strong sense of belonging for all team members, and our process ensures an inclusive environment to applicants of all backgrounds including diverse race, color, sex, sexual orientation or gender identity, physical or mental disability, religion, age, ancestry, national origin, familial status or genetics.If you’re looking for a great next step, and want to feel good about what you do, we’d love to hear from you. Please note reasonable accommodations are provided to qualified individuals with disabilities upon request.
#J-18808-Ljbffr