Quality Records Specialist

ResponsibilitiesInitiation, 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 teamCreate and revise SOPCreate and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)Enter data and retrieve information from SharePoint and Smartsheet testing trackersMay be required to work in office environment.Ability to participate in conference calls.Process external deviation and change records from our Contract Test Laboratories (CTL).Coordinate 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 CompetenciesExperience 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 decisionsMust Haves:1+ years in Cell Therapy1+ years in biomanufacturing1+ years in biotherapeutics1+ years in QA/QC Desired CompetenciesPreferred Bachelors in relevant scientific discipline, or 3 years' experience in biotherapeutics/biomanufacturing QC/QAAdvanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definitionExperience within the Cellular Therapeutics and/or gene-based products.Experience with biologics will be considered.Experience with Clinical and/or Commercial products manufacture, supply and post-approval change managementKnowledge of applicable FDA/EMA regulations in the biotechnology industryExperience managing external suppliers and other supply chain issuesExperience with Quality Systems (change control, deviation and investigation)