Job Title: Quality Management Specialist 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.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.