QUALITY ASSURANCE MANAGER jobs in Kansas City, KS

QUALITY ASSURANCE MANAGER is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a QUALITY ASSURANCE MANAGER identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, QUALITY ASSURANCE MANAGER typically requires a bachelor's degree. Typically reports to a director. The QUALITY ASSURANCE MANAGER manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a QUALITY ASSURANCE MANAGER typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Quality Assurance Manager
  • University of Kansas Medical Center
  • Kansas, KS FULL_TIME
  • Department:
    SOM KC Cancer Center Administration
    -----
    KMCRI-Administration

    Position Title:
    Quality Assurance Manager

    Job Family Group:
    Professional Staff

    Job Description Summary:
    Under the direction of the Quality Assurance Project Manager, The University of Kansas Cancer Center (KUCC) Quality Assurance Manager will work to ensure the Clinical Trial Organization (CTO) established standard processes and procedures are being followed and maintained. Along with the QA team, the QA Manager provides quality control support, assistance and direction for clinical trials supported by KUCC or where KUCC is a participating site. In partnership with the Clinical Trials Office, the QA Team assures clinical trials are being conducted in accordance with Institutional and Regulatory guidelines; therefore, achieving quality and efficacious data and positive clinical outcome with the ultimate goal of innovative, safe, and quality care for cancer patients.

    The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

    Job Description:
    Conditions of Employment: Minimal travel to attend national meetings, etc.

    Required Qualifications

    Education: Bachelor's degree in life sciences or related field.

    Work Experience:
    Experience with FDA regulations relevant to drugs, devices, biologics.
    Experience with CAPA (Corrective Action and Preventive Action) plans and responses.
    Experience with clinical trial monitoring and/or auditing.
    Experience with and understanding of medical, laboratory, and clinical trial concepts and terminology.
    Computer experience including Microsoft Word, Excel and Access applications.

    Preferred Qualifications

    Work Experience:
    5 or more years clinical research experience Previous working knowledge and experience with the FDA inspections and Pharmaceutical sponsors audits.
    Previous working knowledge and experience with the FDA inspections and Pharmaceutical sponsors audits.
    Experience with clinical management database systems utilizing tables, queries, etc.

    Skills:
    Attention to detail with excellent analytical and problem-solving skills.
    Work effectively under periodically stressful conditions.
    Manage multiple tasks and set priorities and meet deadlines.
    Work within a team approach and be motivated to work consistently in a fast-paced, "customer-focused" environment.
    Excellent organizational and communication skills.

    Job Duties Outlined:
    Perform internal audits of the Investigator Initiated Clinical Trials (IITs) conducted at the University of Kansas Cancer Center to ensure protocol compliance, and adherence to Clinical Trials Office Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable Institutional and Regulatory guidelines and requirement(s).
    Work collaboratively with Principal Investigator, CTO Project Directors and other study team members to address concerns following internal and external audits.
    Interact with Pharmaceutical company sponsor Quality Assurance auditors, Clinical Research Organization (CRO) auditors Cooperative group nurse auditors, and other academic institution QA teams in the scheduling, preparation and hosting of external audits both onsite and remote.
    Serve as the primary point of contact for internal audits, external audits, FDA and other Regulatory agency Inspections prior to, during and following conclusion of the audit or inspection.
    Responsible for the preparation of external audits by conducting objective, high level review of clinical trial information managed by the KU Cancer Center, including Cooperative groups, and Pharmaceutical sponsored clinical trials in preparation for external audits.
    Collaborate with Principal Investigator, Clinical study team, Regulatory team, Correlative Laboratory and Investigational Drug Services in preparation of external audits and Regulatory Inspection.
    Be knowledgeable, stay current, and act accordingly within the framework of Regulatory guidelines provided by Federal, State, and local regulatory agencies and ethical guidelines pertaining to the clinical research industry.
    Act as a Quality Assurance resource to clients of the KU Cancer Center, evaluate problems and provide solutions.
    Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures as assigned by Director of Quality Assurance.
    Ensure the effectiveness of the KUCC Quality Assurance team by establishing positive and professional relationships with the KU Cancer Center Principal Investigators, Clinical Trials Office staff including CTO Leadership, Senior Management, Project Management, Clinical Research Coordinators, Clinical Research Data Coordinators, KU Health System staff members and maintain these relationships through constructive and non-punitive communication.
    Participate in SIVs and kick-off meetings to represent quality assurance objectives as assigned by the Director of Quality Assurance.
    Identify project issues and suggest possible solutions; manage problem resolution through expedient and corrective means.
    Investigate and respond to CAPA (Corrective Action and Preventive Action) requests by collaborating with Clinical Trials Office study team members, Investigational Drug Services, Correlative Laboratory and other teams involved with the audit.
    Provide support to the Data Safety Monitoring Committee Coordinator (DSMC) by generating and reviewing reports, creating meeting agenda, and attending quarterly meetings.
    Perform other duties as assigned.

    Required Documents:
    Must provide Cover letter and Resume

    Comprehensive Benefits Package:
    Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus nine paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html

    Employee Type:
    Regular

    Time Type:
    Full time

    Rate Type:
    Salary

    Compensation Statement:
    The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.

    Pay Range:
    $58,000.00 - $86,000.00
    Minimum
    $58,000.00
    Midpoint
    $72,000.00
    Maximum
    $86,000.00

    Application Instructions:
    To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Quality-Assurance-Manager_JR005916 or go to https://careers.kumc.edu/ and search for position number JR005916.

    Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.

    About KU Medical Center:
    The University of Kansas Medical Centers mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu .

    Benefits:
    KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html

    KU is an EO/AAE. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, genetic information or protected Veteran status. http://policy.ku.edu/IOA/nondiscrimination

    jeid-578b97496bcbe34381df633877f233dd
  • 16 Days Ago

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Quality Assurance Manager
  • GPac
  • Kansas, KS FULL_TIME
  • Salary: $95k - 142k per year Health/ Den/ Vis/ 401k Reference: TB-ATS-KC-QA-Mgr-02 Quality Assurance Manager- Aviation Manufacturing SUMMARY: The Quality Assurance Manager is responsible for the opera...
  • 3 Days Ago

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Quality Control/Assurance Manager
  • Chanute Manufacturing
  • Chanute, KS FULL_TIME
  • Chanute Manufacturing Company has an immediate opening for a QC/QA Manager. The qualified candidate should have a working experience in the steel fabrication industry with knowledge of ASME Section I ...
  • 18 Days Ago

S
Quality Control Manager/Quality Assurance Manager
  • Splintek
  • Lenexa, KS FULL_TIME
  • DescriptionSplintek is a Lenexa based, made in the USA manufacturing company in the business of providing high-quality healthcare products to Retailers, Professionals and direct to consumers since 199...
  • 1 Month Ago

U
Quality Assurance/Quality Control Project Manager
  • University of Kansas Medical Center
  • Kansas, KS FULL_TIME
  • Department: SOM EVC Frontiers: University of Kansas Clinical Trials and Translational Science Institute (CTSA) ----- Frontiers: HICTR Position Title: Quality Assurance/Quality Control Project Manager ...
  • 22 Days Ago

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Quality Assurance
  • Line Quest, LLC
  • Lenexa, KS FULL_TIME
  • LineQuest, LLC is a damage prevention company that specializes in providing utility and private line location, GIS mapping and hydro services in multiple markets such as Texas, Oklahoma, New Mexico, N...
  • 14 Days Ago

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0 QUALITY ASSURANCE MANAGER jobs found in Kansas City, KS area

S
Quality Control Manager/Quality Assurance Manager
  • Splintek Inc
  • Lenexa, KS
  • Job Type Full-time Description Splintek is a Lenexa based, made in the USA manufacturing company in the business of prov...
  • 4/18/2024 12:00:00 AM

U
Research Administrator - Internal Medicine
  • University of Kansas Medical Center
  • Kansas City, MO
  • Department: SOM KC Internal Medicine - Administration * ---- Medicine Administration Position Title: Research Administra...
  • 4/18/2024 12:00:00 AM

K
Clinical Research Coordinator
  • Kelly Science, Engineering, Technology & Telecom
  • Kansas City, MO
  • Kelly Science & Clinical® is seeking individuals with clinical trial research experience with an interest in learning an...
  • 4/17/2024 12:00:00 AM

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Director of Quality
  • Hiring Now!
  • Kansas City, KS
  • Description:As Quality Assurance Director, you will be responsible for overseeing all aspects of Quality Assurance and S...
  • 4/17/2024 12:00:00 AM

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Quality Assurance Specialist
  • Hoefer Wysocki
  • Kansas City, MO
  • Job Title Quality Assurance Specialist Job Type Full-time Location Kansas City - Kansas City, MO 64112 US (Primary) Educ...
  • 4/16/2024 12:00:00 AM

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Clinical Research Coordinator
  • Kelly Services
  • Kansas City, MO
  • Clinical Research Coordinator Opportunity: Temp to potential permanent employment Location: Onsite in KS, MO Length: No ...
  • 4/16/2024 12:00:00 AM

H
Microbiology Technologist
  • HCA Healthcare
  • Overland, KS
  • Description 15300 College Blvd, Lenexa, KS 66219 Do you have the career opportunities as a Microbiology Technologist you...
  • 4/16/2024 12:00:00 AM

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Clinical Research Coordinator
  • Kelly Services
  • Kansas City, MO
  • Clinical Research Coordinator Opportunity: Temp to potential permanent employment Location: Onsite in KS, MO Length: No ...
  • 4/14/2024 12:00:00 AM

Kansas City is the third-largest city in the State of Kansas, the county seat of Wyandotte County, and the third-largest city of the Kansas City metropolitan area. Kansas City, Kansas is abbreviated as "KCK" to differentiate it from Kansas City, Missouri, after which it is named. It is part of a consolidated city-county government known as the "Unified Government". Wyandotte County also includes the independent cities of Bonner Springs and Edwardsville. As of the 2010 census, the city had a population of 145,786 residents. It is situated at Kaw Point, which is the junction of the Missouri an...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for QUALITY ASSURANCE MANAGER jobs
$116,544 to $152,334
Kansas City, Kansas area prices
were up 1.7% from a year ago

QUALITY ASSURANCE MANAGER in Juneau, AK
Whatever type of industry you work in, be it retail, health care, software, manufacturing or another industry, chances are that a quality assurance manager helps your business meet and exceed quality-control standards for your services and products.
December 23, 2019
QUALITY ASSURANCE MANAGER in Great Falls, MT
In larger companies, quality assurance managers usually lead an entire department or sector, and they hire employees as part of their duties.
February 13, 2020
QUALITY ASSURANCE MANAGER in Baltimore, MD
Having studied your organization in detail, you not only have an outstanding reputation within the industry, but you are clearly serious about setting and maintaining high Quality Assurance standards.
February 02, 2020