Senior Quality Events Specialist

New Haven, Connecticut
July 22, 2025
$48 / hour
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Job Description

Job Summary:

  • The Quality Events Specialist is a member of the Central Quality Systems and Compliance (CQSC) team.
  • This position will support the execution of the Quality Management System.

Duties and Responsibilities:

Laboratory Investigation Record Quarterly Trending:

  • Generate and analyze laboratory investigation data set(s) for trends.
  • Organize a meeting with each Functional Area Management to review and confirm established patterns/trends and ensuring appropriate CAPAs are created, where applicable.
  • Draft the Laboratory Investigation Trend Report(s).

Laboratory Investigation Record End User Support:

  • Work with end users to address queries in relation to the LIR process.
  • Support end users with the generation of reports to Enhance visibility of LIR records in various functional areas and Support LIR trend review.
  • Pulsing Quality Events Records (Veeva systems and client) on a routine frequency to ensure records are progressing within the quality management system
  • Lead special projects to support the improvement measure across the quality management systems, such as creating Smartsheet interactive and automated dashboards for the visual presentation of workloads across business units.
  • Completing document revision updates and assist in the creation of work tools and template to support the execution of work in the quality management system.

Education and Experience:

  • Bachelor’s degree in scientific or engineering discipline required.
  • Advanced scientific, technical, or business degree a plus.
  • Laboratory methods and investigations experience.
  • Previous group project experience.

Knowledge, Skills and Abilities:

  • Ability to listen, learn, and provide value with the support of mentorship.
  • Good time management skills.
  • Oral and written communication skills.
  • Ability to learn and use software including Microsoft Outlook, PowerPoint, Word, Excel, Smartsheet, MS Teams, survey tools, and Veeva systems.
  • Attention to detail.
  • Interest in electronic systems or software applications to projects.

Physical Requirements / Office Environment:

  • As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer.
  • Engage in communications via phone, video, and electronic messaging.
  • Engage in problem solving and non-linear thought, analysis, and dialogue.
  • Collaborate with others; maintain general availability during standard business hours.

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