Scientist II

Target PR Range: 39-49/hr Depending on experienceCreate and manage change documentation for PDS&T Analytical organization and other groups within PDS&T. This will include learning the OneTrack change management system, initiating, managing, overseeing and following up on change management tasks and due dates. Responsibilities may also include redlining and creation of documents (e.g. test methods, standard operating [procedures, etc.) and writing of protocols and reports for test method validations and transfers and for instrument qualifications. This role provides a centralized key support function to allow scientists more time to focus on projects and less time learning systems they seldom or occasionally use. The person filling this role will be the Subject Matter Expert for OneTrack Change Management for the department. Initiate change requests for commercial products and instruments. Act as project owner, or initiator. Typical projects include local TMTs, cleaning method validations and instrument qualifications.Serve as Change Coordinator for local change plans or global change plansWork with requestors of change to ensure change proposals are ready for reviewFacilitate cross functional team meetings with individualsMonitor open change requests and provide visibility to requestors and change managersAccountable for the compliance of the change request documentation to the applicable processes and proceduresResponsible for maintaining an accurate, cGMP compliant documentation change control system Qualifications BS in a scientific field3+ years’ experience in a cGMP related environmentExperience in analytical testing (chromatography, wet chem) preferred but not necessaryAbility to work well in a project team environmentGood oral, written and presentation skillsStrong documentation skillsStrong computer skills utilizing a Microsoft environment (e.g. Word, Excel, PowerPoint)Knowledge of OneTrack Change Management system is preferred but not necessary.