Global Supplier Quality, External QC – Quality RecordsLocation: Summit, NJPurpose And Scope Of Position: The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL). Other duties may include; coordinate shipping and testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT. This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.Required Competencies: Knowledge, Skills, and Abilities:Experience with deviation and change control management, preferably with Infinity systemsStrong organizational skills, including ability to follow assignments through to completionAbility to work in a fast paced environment, meet deadlines, and prioritize work from multiple projectsExcellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teamsDetail oriented with demonstrated application in problem solvingWith moderate oversight from manager, think strategically and understand global impact of decisionsDuties And Responsibilities:Initiation, facilitation, and tracking of quality recordsProvide regular communication and metrics for status of quality recordsEffectively communicate issues, risks and proposed solutions within the organizationProvide communication, support, and guidance to CTLs within the QA vector and upstream material teamWorking closely with other GSQ QC members to submit and track sample material for testing at CTLCreate and revise SOPCreate and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)Enter data and retrieve information from Sharepoint and Smartsheet testing trackersWorking Conditions (US Only): May be required to work in office environment.
Sitting, standing and computer work is required. Ability to participate in conference calls.