Quality Assurance Officer

Department of Health and Human Services (DHHS)

Opening Date: September 10, 2024

Closing Date: September 24, 2024

Job Class Code: 9248
Grade:  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 Responsibilities
As a key member of the HETL team, your core responsibilities will include:
•    Participation in annual biosafety and chemical safety trainings
•    Oversight of quality assurance and quality control measures in the Clinical microbiology section within HETL
•    Review of CLIA guidelines to assure laboratory compliance
•    Review of IQCP/QA/QC metrics for all standard operating procedures (SOPs)
•    Oversight of CLIA competencies and proficiencies to assure annual completion
•    Preparation of all documents for CLIA inspections
•    Developing and coordinating monthly QA Committee meetings with clinical and LRN Staff
•    Developing and coordinating quarterly meetings with the Epi-Lab Work Group
•    Developing, implementing, and coordinating the internal audit program to document program effectiveness of
•    safety/facilities/procedures/quality assurance/quality control 
•    Leading 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 State
•    Developing, implementing, and coordinating a non-conformance program through quality notification forms (QNFs) and corrective actions reports (CARs)
•    Develops and conducts internal audits
•    Managing PJF, RFP, and bidding process for calibration services, document management software, temperature monitoring software, and other quality services
•    Coordination with the Laboratory Safety Officer
•    Developing, reviewing, and approval of policies, manuals, standard operating procedures, and forms for HETL and Sentinel Laboratories
•    Collaboration with staff in the Maine CDC and other state agencies on emergency preparedness
•    Participation in the Federal CDC LRN-B network
•    Developing an integrated system of public health, hospital, and independent laboratories for preparedness and detection of bioterrorism events and diseases of public health importance
•    Providing coordination of periodic statewide on-site visits and training to Sentinel laboratories as required by the Federal CDC and LRN-B
•    Organizing meetings, communication, and coordination between the HETL and Sentinel laboratories
•    Providing design evaluation of the of Sentinel laboratory facilities and recommendation for changes, as needed
•    Managing and coordination of an outreach program with all Sentinel laboratories for sample submissions, workflows, and post-analytical processes for all patient testing
•    Providing assessment and evaluation of Sentinel laboratory capability and capacity to facilitate LRN response
•    Managing 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 skills
•    Professional certifications such as ASCP, MLT, or MT
•    Knowledge or experience with federal laboratory accreditation programs such as CLIA or CAP 
•    Knowledge of a laboratory information system (StarLims)
•    Extensive technical knowledge of serology, bacteriology, virology, molecular, biology, and histology laboratory methods
•    Ability to establish and maintain effective working relationships with a diverse group of internal and external partners
•    Ability 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 assistance
•    Ability to visit all Sentinel Laboratories in Maine
•    Ability to troubleshoot and problem solve when challenges arise
•    Ability to multi-task and re-prioritize on a daily basis to meet deadlines
•    Knowledge of and experience with website development and maintenance

Thinking about applying?

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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.

Note: Benefits may vary somewhat according to specific collective bargaining agreements and are prorated for anything less than full-time.

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.