LABORATORY QUALITY ASSURANCE SPECIALIST

Introduction

Located on the western shore of Lake Michigan, Milwaukee is an urban hub bursting with energy. Milwaukee provides a casual sophistication – big city appeal without the big-city hassles. We are accessible and affordable, and our residents are welcoming. Milwaukee brings together its unsurpassed old world charm with a breathtaking art museum, top-flight arts and cultural attractions, professional sports, lakefront festivals, recreational opportunities and great restaurants.

The City of Milwaukee is proud to employ a diverse workforce that is committed to providing exemplary service to the City’s residents. If you have a passion for being a part of an inclusive team of public servants, please consider the following opportunity.

Purpose

The Laboratory Quality Assurance Specialist is responsible for ensuring compliance with regulatory standards to support laboratory quality management and to promote a culture of safety.  Reporting to the Director of the Laboratory Operations Director, the Laboratory Quality Assurance Specialist ensures operational, business, outreach and outbreak response functions for the MHD laboratory.

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 design of standard operating procedures, method detection limits and data quantification; assure documentation and quality assessment of laboratory functions.
• Using statistical methods, perform routine reviews to ensure quality of laboratory data, reporting and documentation; assist Laboratory Information Systems (LIS) Administrator in assuring that LIS meets data quality requirements.
• 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) 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.  

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.
• Coordinate and lead quarterly Laboratory Safety Committee meetings with section staff, ensuring that safety issues are discussed and addressed properly.
• Conduct safety audits Represent the Laboratory on monthly departmental safety committee meetings.  

Operational

• Work with the Laboratory Operations Manager to develop and lead an internal auditing process to assist with monitoring budget and grants, billing and payment functions and the procurement of laboratory supplies and equipment; participate in contract management and inventory control.
• Assist with meeting customers’ needs, including disseminating relevant information and conducting periodic site visits with clients.
• Support Laboratory System Improvement Program (L-SIP) efforts and work collaboratively with partners to identify and implement system improvement opportunities.
• 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.

We welcome qualified individuals with disabilities who are interested in employment and will make reasonable accommodations during the hiring process in accordance with the Americans with Disabilities Act (ADA) of 1990, as amended by the Americans with Disabilities Act Amendments Act (ADAAA) of 2008.

Conditions of Employment

• Must work safely in the presence of human specimens including blood, urine, and other clinical samples, body fluids or tissues.
• May be exposed to infectious agents or toxic laboratory chemicals.
• Required to wear a particulate respirator (N95 or higher) and respirator fit test annually or frequency recommended by the MHD Laboratory/Medical Directors. 
• May be assigned to 24-hour emergency on-call rotation schedule (including weekends). 
• May be required to participate in the Select Agent Program and must receive FBI background clearance.
• May travel outside the City of Milwaukee, occasionally overnight, for training purposes or for participation in job related meetings.
• Based upon each department’s responses to the COVID-19 pandemic and the needs of each department, employees may be expected to work from home intermittently or continuously.

Minimum Requirements

1. Bachelor’s degree in laboratory science, medical technology, biology, microbiology, molecular biology, chemistry or a related field from an accredited college or university.
2. Two years of recent experience in a clinical, environmental or public health laboratory, including work with laboratory quality management systems.  

Equivalent combinations of education and experience may also be considered.

IMPORTANT NOTE: Academic (college and graduate) transcripts are required and must be received by the application period closing date. Transcripts should be attached to your online application. Applications without transcripts attached will be considered incomplete and will be rejected. Student/unofficial copies are acceptable; however, your transcript must be legible and include your college/university name, your name, the degree completed (if applicable) and the date completed.

Desirable Qualifications

Experience in laboratory safety, regulatory compliance and project management.

Quality Improvement and Lean and/or Six Sigma training. 

Knowledge, Skills, Abilities & Other Characteristics

Technical Skills

• Ability to implement and maintain quality assurance programs.
• Ability to measure, assess and improve the quality of laboratory services.
• Ability to learn and apply Lean and/or Six Sigma management practices.
• Ability to identify risk areas.
• Ability to design standard operating procedures, method detection limits and data quantification.
• Knowledge of statistical methods related to laboratory performance and regulation.
• Knowledge of laboratory operations and workflows including pre-analytic, analytic and post-analytic phases of testing.
• Knowledge of and the ability to effectively utilize Laboratory Information Management Systems (LIMS).
• Knowledge of and ability to apply CLIA and other state and federal regulatory guidelines.
• Ability to analyze and interpret national standards, guidelines, regulations and laws pertaining to clinical laboratory quality management and safety.

Communication Skills 

• Ability to write business correspondence and standard operating procedures. 
• Ability to speak clearly and persuasively in order to effectively present information and respond to questions from both technical and non-technical staff.

Computer Skills 

• Ability to effectively utilize a personal computer with both Windows and Linux operating systems.
• Ability to effectively utilize software applicable to various reporting systems, particularly the Laboratory Information Management Systems (LIMS), local and cloud storage (e.g. Amazon web-services- AWS) and inventory control.
• Ability to efficiently utilize Microsoft office programs including Excel, Access, Word, PowerPoint, internet search and use of application database and software.

Interpersonal Skills 

• Ability to maintain positive working relationships with clients, multi-cultural and multi-disciplinary staff, other agencies, and the public.
• Ability to balance team and individual responsibilities.
• Ability to exhibit objectivity and openness to others’ views.
• Ability to provide and receive feedback in a positive manner.
• Ability to contribute to a positive team spirit.

Judgment and Analysis 

• Ability to maintain patient and data confidentiality.
• Ability to solve practical problems. 
• Ability to work under pressure and handle multiple and changing priorities.
• Ability to think and respond quickly and efficiently in a fast-paced environment.
• Ability to plan and organize work.

Current Salary

The current salary range (2 HN) is $54,942-$76,806 annually and the resident incentive salary range for City of Milwaukee residents is $56,590-$79,110 annually.  Appointment above the minimum is possible based upon level of experience and other qualifications and is subject to approval.  

The City of Milwaukee provides a comprehensive benefit program that includes the following: 

• Defined Benefit Pension Plan
• 457 Deferred Compensation Plan
• Health and Dental Insurance 
• Comprehensive Wellness Program
• Onsite Clinic Services
• Onsite Employee Assistance Program
• Alternative Work Schedules 
• Long Term Disability Insurance
• Group Life Insurance 
• Tuition Benefits 
• Paid Vacation
• 11 Paid Holidays 
• Paid Sick Leave and other paid leaves
• Flexible Spending Arrangement 
• Commuter Value Pass  

For full details of the benefits offered by the City of Milwaukee, please visit https://city.milwaukee.gov/der/benefits

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Selection Process

THE SELECTION PROCESS will be job related and will consist of one or more of the following: education and experience evaluation; written, oral, or performance tests, or other assessment methods. The Department of Employee Relations reserves the right to call only the most qualified candidates to oral and performance examinations. Oral examinations may include written exercises. Selection process component weights will be determined by further analysis of the job.  

INITIAL FILING DATE – The examination will be held as soon as practical after Tuesday, January 19, 2021. Receipt of applications may be discontinued at any time after this date without prior notice.  However, recruitment may continue until the needs of the City have been met. Qualified applicants will be notified of the date, time, and place of the examination. Unless otherwise required by law, the City of Milwaukee will not provide alternative test administration. The applicant is responsible for attending all phases of the job selection process at the time and place designated by the City of Milwaukee.

Additional Information

• Applications and further information may be accessed by visiting, http://city.milwaukee.gov/jobs.
• If you would like assistance completing an application, please contact the Department of Employee Relations at (414) 286-3751 or [email protected].
• The Department of Employee Relations is located at City Hall, 200 E. Wells St., Room 706, Milwaukee, WI 53202.

Conclusion

EEO 206

The City of Milwaukee values and encourages diversity and is an equal opportunity employer.