QUALITY ASSURANCE MANAGER jobs in Richmond, KY

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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Manager of IT Quality Assurance
  • Summit Biosciences Inc.
  • Lexington, KY FULL_TIME
  • Summary:

    Responsible for driving and executing the overall QA strategy that aligns with the wider IT strategy across all QA teams.  This includes new technologies, automated systems, eQMS, ERP system implementation/integration, and support of electronic Facilities & Engineering systems.  In this role, the candidate would ensure that drug development, registration, and commercialization activities, through the use of electronic systems, are compliant with all applicable regulatory requirements and guidelines.

     

    Essential Duties:

    • Design and execute the Quality Assurance strategy in close partnership with various departments.  Coordinate with IT, Manufacturing, QA, Development, Facilities & Engineering, and Validation to identify and prioritize key systems initiatives and ensure cohesive end-to-end quality assurance of all enterprise/software based/web-based solutions.
    • Lead the IT QA group through a clearly defined process-driven methodology to ensure project goals, QA standards, and internal best practices are routinely followed.
    • Partner with business and development teams to review business and technical requirements. 
    • Participate in teams to develop comprehensive test strategies, plans, impact analysis, specifications, and test cases for effective assurance and testing functions.  May attend factory acceptance testing or site acceptance testing for equipment with automation.
    • Partners with IT and QA for GxP IT supplier audits, review master service agreements, and quality agreements.
    • Review and approve change controls, validation protocols, and operational procedures for new equipment or systems with automation, that require Web services, or batch-based integrations/implementations. 
    • Perform user acceptance testing where applicable, communicate business risks and mitigation plans based on outcomes of testing.
    • Contribute to and define best practices, processes, scorecards, KPIs, and tools for the QA organization ensuring overall productivity and quality is measured at all times and improved in line with targeted milestones.
    • Assumes ownership of the QA Administrator role in electronic systems (where applicable), review routine updates/feature enhancements provided by SaaS vendors, and provide feedback to teams toward change control and required testing. 
    • Review and approval of preventative maintenance (addition of new equipment and utilities, and routine PMs) from the Quality perspective.  Review and approval of validation protocols for new equipment and systems.
    • Reviews new/draft batch records involving new production equipment, new lab equipment, and systems with automation.
    • Reviews and approves calibration related documents and calibration procedures for new instruments.
    • Partner with various departments to develop and deploy training for electronic systems, provide ongoing support after deployment, and assist with issue resolution.

     

    Qualifications:

    • BS in chemistry, biology, information technology, computer sciences or related field
    • 8 years GMP quality experience
    • 3 years supervisory/management experience
    • Experience required in managing software/application quality assurance at scale
    • Proven track record in leading development of test automation strategy, tools, and frameworks
    • Experience with ERP systems, electronic Quality Management systems, electronic preventative maintenance/corrective maintenance/calibration systems such as BMRAM
    • Excellent technical writing, project management, and organizational skills
    • Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization
    • Familiar with the necessary components of facility qualification and validation activities
    • Extensive knowledge of cGMP regulations and ICH guidelines
    • Flexible, adaptable, self-motivated and able to work well independently and across teams
    • Ability to work in a lean, action oriented organization and demonstrate a strong work ethic
    • Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team
    • Demonstrated ability to make and act on decisions while balancing speed, quality, and risk
    • Significant knowledge in drug product manufacturing, quality assurance, validation, quality control, regulatory affairs, and technology transfer
    • Ability to think clearly and decisively; remain calm under adverse conditions
    • Demonstrated ability to work independently or in groups in a complex, changing environment
    • Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments
    • Ability to provide innovative, compliant ideas, or alternatives that create value, including seeking new information and external insights

     

  • 15 Days Ago

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Quality Assurance Associate
  • Abacus Service Corporation
  • Winchester, KY CONTRACTOR,FULL_TIME
  • Description/Commen - ONSITE - TEMP TO PERM - DURATION - 3-6 MONTHS TO CONVERT - SHIFT - MON - FRI 2PM - 10:30PM. The QA Associate is responsible for the Quality support functions associated with the m...
  • 21 Days Ago

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Quality assurance coordinator
  • Kentucky Blood Center
  • Lexington, KY FULL_TIME
  • $500 Sign-On Bonus (after 90-days) Full-time position. Monday - Friday 8 : 30 a.m. to 5 : 00 p.m. Kentucky Blood Center is seeking a Quality Assurance (QA) Coordinator who will be responsible for perf...
  • 24 Days Ago

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Senior Quality Assurance Engineer
  • CoorsTek Inc
  • Lexington, KY FULL_TIME
  • It's exciting to work for a company that makes the world measurably better. We're committed to bringing safety, quality, and customer focus to the business of advanced ceramics manufacturing. Job Titl...
  • 10 Days Ago

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Quality Assurance Lab Technician
  • Sunset
  • Berea, KY FULL_TIME
  • Primary Responsibilities: Monitor and verify Critical control Points (CCPs) meet requirements and ensure any corrective actions are properly performed and recorded Conduct and support internal audits ...
  • 11 Days Ago

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Quality Assurance Intern
  • Valvoline Global Operations
  • Lexington, KY INTERN
  • Overview Why Valvoline Global Operations? Valvoline Global is a worldwide leader in automotive and industrial solutions, creating future-ready products and best-in-class services for partners around t...
  • 13 Days Ago

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0 QUALITY ASSURANCE MANAGER jobs found in Richmond, KY area

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Director of Quality
  • The Judge Group
  • Lexington, KY
  • Description:As Quality Assurance Director, you will be responsible for overseeing all aspects of Quality Assurance and S...
  • 3/28/2024 12:00:00 AM

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Research Administrator Assistant
  • The University of Kentucky
  • Lexington, KY
  • The Office of Sponsored Projects Administration (OSPA) is seeking an Research Administrator Assistant. OSPA is responsib...
  • 3/28/2024 12:00:00 AM

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Manufacturing Manager
  • The Judge Group
  • Lexington, KY
  • Our manufacturing client is seeking a Manufacturing Manager for their facility near Louisville, KY.RESPONSIBILITIES:Resp...
  • 3/28/2024 12:00:00 AM

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Associate Tech Specialist TECHM-JOB-29288
  • Keylent
  • Irvine, KY
  • Associate Tech Specialist TECHM-JOB-29288 Location: IRVINE Skill: SAP S/4HANA Central Finance Description " As an SAP S/...
  • 3/28/2024 12:00:00 AM

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Adjunct Faculty - Surgical Tech.
  • Kentucky Community and Technical College System
  • Lexington, KY
  • Adjunct Faculty - Surgical Tech. Job no: 492661 Work type: Part-time Location: Lexington, KY Categories: Adjunct Faculty...
  • 3/28/2024 12:00:00 AM

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Research Coordinator RN
  • Catholic Health Initiatives
  • Lexington, KY
  • **Overview** Saint Joseph Hospital is a 433-bed facility located in Lexington Kentucky. Founded in 1877 a small group of...
  • 3/27/2024 12:00:00 AM

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Restaurant Manager
  • Hooters of America, LLC
  • Richmond, KY
  • Overview: Hooters of America LLC is looking for a Restaurant Manager in our Hooters of Richmond,KY! Manages various area...
  • 3/26/2024 12:00:00 AM

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Compensation Specialist
  • Kentucky Community and Technical College System
  • Versailles, KY
  • Compensation Specialist Job no: 494199 Work type: Full-time Location: Versailles, KY Categories: Staff Title: Compensati...
  • 3/26/2024 12:00:00 AM

Richmond is a home rule-class city in and the county seat of Madison County, Kentucky, United States. It is named after Richmond, Virginia, and is the home of Eastern Kentucky University. The population was 33,533 in 2015. Richmond is the third-largest city in the Bluegrass region (after Louisville and Lexington) and the state's sixth-largest city. Richmond serves as the center for work and shopping for south-central Kentucky. Richmond is the principal city of the Richmond–Berea Micropolitan Statistical Area, which includes all of Madison and Rockcastle counties. Richmond is located in Madison...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for QUALITY ASSURANCE MANAGER jobs
$110,372 to $144,269
Richmond, Kentucky area prices
were up 1.2% 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