Total Quality Senior Specialist jobs in Hamden, CT

Total Quality Senior Specialist contributes to the development, implementation, administration and measurement of total quality management programs, including Six Sigma initiatives. Provides expertise to cross functional teams to facilitate total quality methods, training, tool development, and logistical support. Being a Total Quality Senior Specialist coordinates with production, operations, customer service and other functions to implement programs. Typically requires a bachelor's degree. Additionally, Total Quality Senior Specialist typically reports to a manager. The Total Quality Senior Specialist work is highly independent. May assume a team lead role for the work group. A specialist on complex technical and business matters. To be a Total Quality Senior Specialist typically requires 7+ years of related experience. (Copyright 2024 Salary.com)

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Senior Quality Specialist (Clinical Trials)
  • System One
  • New Haven, CT OTHER
  • Title:  Senior Quality Specialist
    Location:  New Haven, CT
    Schedule:  M-F 37.5 hours, occasional weekend and evening hours 
    Type:  Direct Hire

    Our client is seeking an individual with strong background in quality and/or compliance for clinical trials.  Some monitoring or experience running internal QA auditing type programs ideal.  

    Requirements:
    • Bachelor’s Degree in degree in a health-related discipline, or other related field, and a minimum 5 years’ experience working in a clinical research environment, or an equivalent combination of education and related experience.
    • Demonstrated mastery of human subjects research related standards and ability to interpret, analyze, apply, and communicate applicable ethical principles, laws, regulations, guidance, policies, academic & industry trends, and other standards. Demonstrable understanding of clinical research review, approval & monitoring processes from start-up to close-out.
    • Strong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.).
    • Oncology clinical research experience strongly preferred.
    • Preferred competency with Clinical Trials Management Systems (CTMS) and Electronic Medical Record (EMR) systems.
    Preferred Licenses or Certifications:
    SOCRA/ACRP (or equivalent) certification preferred

    Responsibilities:
    The Sr. Quality Specialist is responsible for assessing the quality of clinical trials conducted. This position participates in all aspects of clinical research integrity, compliance and privacy initiatives, including workforce orientation, incident response and documentation, clinical research monitoring and quality reviews, staff education on clinical research compliance topics, and providing support for policy and procedure development.
    • Conducts risk based internal monitoring and quality control reviews of supported studies and research activities, with a focus on moderately to highly complex studies, and reviewing compliance with study protocols, Good Clinical Practices, and policies and procedures. 
    • Work with Director, Quality and Education to provide feedback, deficiencies and common trends identified in quality review to ensure timely and effective change control to improve overall quality. 
    • Leads the internal monitoring and quality control review effort by mentoring and the planning and conduct of monitoring and quality reviews. 
    • Develops corrective and preventive actions (CAPAs) in collaboration with Clinical Research Managers and leaders, when issues are detected in order to avoid further deviations or other compliance issues. Also responsible for quality follow-up on CAPAs that are implemented, in order to ensure adherence and effectiveness. 
    • Coordinates and manages the preparation of all external audits conducted by study sponsors. 
    • Collaborates and supports Quality Assurance & Monitoring team on regulatory authority (e.g.: FDA, EMA) inspection preparedness for CTO supported trials as needed. 
    • Partner with the Sr. Training Specialist to educate and provide guidance to staff members concerning internal processes and procedures which ensure that all aspects of clinical studies are conducted according to Good Clinical Practice Guidelines. 

    #M3
  • 11 Days Ago

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Aircraft Sourcing Specialist
  • Total Aerospace Services
  • New Haven, CT FULL_TIME
  • Do you want to be a part of a team of aviation innovators who are helping change the industry landscape? Our client is the world’s leader in portable ex-vivo perfusion and assessment of donor organs f...
  • 25 Days Ago

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Corporate Aircraft Sourcing Specialist
  • Total Aerospace Services
  • New Haven, CT FULL_TIME
  • Do you want to be a part of a team of aviation innovators who are helping change the industry landscape? Our client is the world’s leader in portable ex-vivo perfusion and assessment of donor organs f...
  • 25 Days Ago

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Senior Quality Engineer
  • identifeye HEALTH Inc.
  • Guilford, CT FULL_TIME
  • Who We Are Join us on our mission to democratize access to the abundance of health information in the human eye! Here at identifeye HEALTH Inc., we’re pioneering a new branch in diagnostics between la...
  • 28 Days Ago

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Senior Quality Engineer
  • LanceSoft Inc
  • North Haven, CT FULL_TIME
  • Company DescriptionMedical Device Industry.Job DescriptionPerforms Quality Engineering functions in support of projects associated to product development/change including: design verification (design ...
  • 1 Month Ago

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Senior Quality Engineer
  • HANWHA AEROSPACE USA LLC
  • Cheshire, CT FULL_TIME
  • Senior Quality Engineer - ExemptHanwha Aerospace USA has long been recognized as a leader in the development and supply of flight critical Aerospace/Defense components and assemblies. Operating out of...
  • 1 Month Ago

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0 Total Quality Senior Specialist jobs found in Hamden, CT area

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Senior Quality Specialist (Clinical Trials)
  • System One Holdings, LLC
  • New Haven, CT
  • Title:Senior Quality Specialist Location:New Haven, CT Schedule:M-F 37.5 hours, occasional weekend and evening hours Typ...
  • 4/19/2024 12:00:00 AM

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Quality Engineer II
  • Artech LLC
  • North Haven, CT
  • Job Title - Quality Engineer II Job Id:12652 Location - 195 McDermott Rd, North Haven, Connecticut, United States of Ame...
  • 4/19/2024 12:00:00 AM

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Quality Assurance Manager
  • Roehm
  • Wallingford, CT
  • WHO WE ARE We are a leading supplier of methacrylate chemistry. As a global company with around 3,500 employees, we are ...
  • 4/18/2024 12:00:00 AM

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Repair Cell Production Manager
  • Ultra
  • Wallingford, CT
  • Unleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies. Step into a world where cut...
  • 4/18/2024 12:00:00 AM

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Quality Systems Manager
  • Medtronic
  • North Haven, CT
  • Manages a team of Supplier Quality Engineers that are responsible for ensuring delivery of quality parts, materials, and...
  • 4/18/2024 12:00:00 AM

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Quality Control Lab Technician-NIGHT SHIFT
  • BYK USA Inc.
  • Wallingford, CT
  • Job description $22 An Hour + $2 Night Shift Differential Shift: 7pm-7:30 am Rotating BYK Additives & Instruments is one...
  • 4/17/2024 12:00:00 AM

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Wendy's Shift Manager - Hamden, CT - 2195 Dixwell Avenue
  • Meritage Hospitality Group Inc
  • Hamden, CT
  • EASY APPLY: Text "JOIN US" to 25000 or go to http://oli.vi/xnS5D Our Shift Managers provide daily leadership to ensure t...
  • 4/17/2024 12:00:00 AM

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Program Manager | Manufacturing | Mil/Aero Products
  • TIMES MICROWAVE SYSTEMS
  • Wallingford, CT
  • Job Description Job Description Great opportunity to join a winning team with an industry leader! Qualified candidates f...
  • 4/16/2024 12:00:00 AM

Hamden is a town in New Haven County, Connecticut, United States. The town's nickname is "The Land of the Sleeping Giant." The population was 60,960 at the 2010 census. Hamden is a suburb of the city of New Haven. The town of Hamden ranked #53 in the CNN Money list of "America's best small cities" in 2012. In 2008, Fortune Magazine and CNN Money picked Hamden as #33 on their "Best Place to Live and Launch" list, citing Hamden's great blend of urban and suburban lifestyles. The article also pointed out Hamden's exceptional education system as well as its "New England Charm". According to the U...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Total Quality Senior Specialist jobs
$121,691 to $144,807
Hamden, Connecticut area prices
were up 1.7% from a year ago

Total Quality Senior Specialist in Columbia, SC
Likely to be either a specialist within a particular focus area for QHSE, e.g., environmental, transportation, training, etc., or is based at a specific location in a generalized role.
February 18, 2020