Hybrid Details: Onsite 60%

Duration: 12 months to start

Job Description
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.

You will be responsible for:

• 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
    • Support LIR trend review
• Pulsing Quality Events Records (Veeva systems and Kneat) 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

• Bachelor’s degree in scientific or engineering discipline required. Advanced scientific, technical, or business degree a plus
• Laboratory methods and investigations experience
• 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, Smartsheets, MS Teams, survey tools, and Veeva systems.
• Attention to detail.
• The duties of this role are generally conducted in an 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.

• Interest in electronic systems or software applications to projects.
• Previous group project experience