Quality Management Specialist
: Job Details :

Job Title: Quality Management SpecialistLocation: Rahway, NJType: ContractResponsibilities Key collaborator working closely with site personnel and Clinical Supply QMS Redesign Team to ensure successful implementation of new QMS by assisting with project-specific tasks, including but not limited to, project support, document management, documentation review, technical editing, meeting coordination and facilitation, training, onboarding, and other administrative tasks.Perform documentation review and technical editing to ensure consistency (e.g. language, formatting, etc.) within the Redesign Team and across the Clinical Supply networkServe as a communication channel between global network site personnelAssist with site metrics collection/reporting and sharing of success stories/achievementsSupport development of the learning strategy for new and revised QMS topics, including access to LMS content and generation of reports, creation of training materials and communication of training requirementsSupport project management activities, optimization of communication strategy and change management strategyManagement of document lifecycle (new or existing documents) and review/approval workflowsMaintain electronic repository/communication mechanism (e.g. QMS SharePoint Site, Microsoft Teams)Serve as a change agent helping the Clinical Supply QMS Redesign Team drive culture change.Requirements Bachelor's Degree in an appropriate scientific or business field of studyMinimum of five (5) years' experience in the Pharmaceutical or equivalent industryStrong technical knowledge, skills, and experience in project and documentation managementExcellent verbal and written communication skills as well as presentation skillsStrongly developed cross-functional teamwork and collaboration skillsExperience in Microsoft tools such as Outlook, Word, Excel, PowerPoint, SharePoint, Teams and Project is strongly recommendedExperience with document editing in MS Word (e.g. formatting, forms, styles, templates, etc.)Experience directly related to the development of Quality Standards and core requirements for Market Supply and/or Clinical SupplyExperience directly related to Quality Assurance, Quality Control, GMP regulations or pharmaceutical regulationsKnowledge of processing mapping and optimization.BenefitsSystem One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.