Senior Quality Events Specialist

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job 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.

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 ensure 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 too.
• Enhance visibility of LIR records in various functional areas.
• Support LIR trend review.
• Pulsing Quality Events Records (Veeva systems and knead) 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 smart sheet interactive and automated dashboards for the visual presentation of workloads across business units.
• Completing document revision updates and assisting in the creation of work tools and template to support the execution of work in the quality management system.

Requirements:

• 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, Smartsheet, 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 accommodation, to use a computer; engage in communication 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 for projects.
• Previous group project experience.

All your information will be kept confidential according to EEO guidelines.