Job Title: Compliance Specialist Location: New Brunswick, NJ Hours/Schedule: Mon-Fri (normal business hours) Type: Contract Overview Leading pharmaceutical company looking for an experienced Compliance Specialist. Ideal candidates should have experience with Deviations, CAPA metrics/generation and management within a GMP environment. Responsibilities Training and Documentation: + Handle daily training and documentation tasks, ensuring compliance with GxP documentation and data integrity principles. + As trainee SME, develop and evaluate training curricula, monitor training materials, and assess program effectiveness. + Conduct training impact assessments and create Role Based Training matrices. + Generate training metrics, create job aids/end- to-end workflows and conduct team trainings as required. Content Management: + Manage PD Electronic Document Management Systems (e.g., Veeva) by creating, reviewing, and maintaining CSO-controlled documents. + Oversee documents scheduled for periodic reviews and updates related to CAPAs. Digital Solutions and SharePoint Management: + Establish and manage a SharePoint site to enhance team communication and collaboration. + Identify, implement and support digital solutions to replace paper-based processes or enhance existing processes. + Evaluate and recommend electronic solutions to streamline workflows. Quality and Compliance: + Perform quality investigations, including root cause analysis, CAPAs and ensure timely completion of investigations. + Ensure compliance with GxP documentation and data integrity principles in daily work. Continuous Improvement: + Identify opportunities for process optimization and implement best practices. + Collaborate with cross-functional teams to drive continuous improvement initiatives. + Monitor and analyze performance metrics to identify areas for improvement. + Facilitate training sessions and workshops to promote a culture of continuous improvement. Team Collaboration and Problem Solving: + Address day-to-day challenges independently in a timely and professional manner. + Collaborate effectively with team members to resolve routine issues. + Exercise good judgment in identifying when to escalate technical or business challenges to upper management Requirements + Proficiency in Excel, Word, Visio, SharePoint, PowerPoint, etc. + Experience with Training Management systems/principles (e.g., SuccessFactors, Compliance Wire) and QMS Documentation Systems (e.g., EDMS, Veeva). + Strong background in Good Manufacturing Practices (GMP) and GxP documentation, with familiarity with Data Integrity principles. + Experience in deviation writing, change controls, etc. + Highly experienced in creating, managing, and maintaining SharePoint sites; experience with AI tools is a plus. + Excellent attention to detail with the ability to work accurately and independently in a busy, demanding environment. + Strong collaboration and communication skills. + Ability to work within strict timelines, showcasing excellent organizational and time management skills. + Ability to negotiate and act as a mediator between functional areas while meeting timelines and paying attention to details. 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. Ref: #568-Clinical 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.