When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Job Title: Senior Quality Events Specialist Bill Rate: Location: New Haven Onsite: 60% Description This is what you will do: • 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: o Generate and analyze laboratory investigation data set(s) for trends o Organize a meeting with each Functional Area Management to review and confirm established patterns/trends and ensuring appropriate CAPAs are created, where applicable o Draft the Laboratory Investigation Trend Report(s) • Laboratory Investigation Record End User Support o Work with end users to address queries in relation to the LIR process o 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 You will need to have: • 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. We would prefer for you to have: • Interest in electronic systems or software applications to projects. • Previous group project experience EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
Job Title
Global Quality Specialist|ALX|US