Quality Management Specialist

Job Title: Quality Management Specialist Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed. Location: West Point, PA Hours/Schedule: Hybrid; Mon-Fri 8am- 5pm Type: Contract Responsibilities 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 network Serve as a communication channel between global network site personnel Assist with site metrics collection/reporting and sharing of success stories/achievements Support 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 requirements Support project management activities, optimization of communication strategy and change management strategy Management of document lifecycle (new or existing documents) and review/approval workflows Maintain 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 study Minimum of five (5) years' experience in the Pharmaceutical or equivalent industry Strong technical knowledge, skills, and experience in project and documentation management Excellent verbal and written communication skills as well as presentation skills Strongly developed cross-functional teamwork and collaboration skills Experience in Microsoft tools such as Outlook, Word, Excel, PowerPoint, SharePoint, Teams and Project is strongly recommended Experience 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 Supply Experience directly related to Quality Assurance, Quality Control, GMP regulations or pharmaceutical regulations Knowledge of processing mapping and optimization. Benefits System 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.

Created: 2025-01-12