Job Title: Senior Specialist Location: Warren, NJ Hours/Schedule: Monday - Friday, normal business Hours Type: Contract Overview Leading pharmaceutical company looking for an experienced Senior QA Engineering Specialist. Ideal candidates should have a BS degree with at least 5 years of experience in the pharmaceutical industry. Responsibilities + Ensure control of systems, processes and products through facilitation of CCRB. + Represent site and provide impact assessment for global changes at Global CCRB + Monitor and track external audit/inspection commitments to ensure timely closure. + Track site change controls and ensure appropriate requirements are identified and completed for implementation. + Provide weekly change control due date updates to the Tier board metrices. + Must be skilled in planning and organizing, decision-making, and building relationships. + Familiar with Veeva Vault QMS system. + Able to effectively multi-task. + Reporting Relationship + Reports to Senior Manager, QA Engineering Requirements + B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry. + Experience with cGMP manufacturing, Quality, and compliance. + Excellent verbal and written communication skills. + Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. + Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance. + Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process. + Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy. + Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across a majority of the job function. + Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams. + Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. + Must possess an independent mindset and tenacity. + Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. 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.