Specialist, Quality Systems
About the position The Specialist for Quality Systems at the Summit, NJ Cell Therapy Manufacturing will be responsible for the CAPA, Deviation and System ownership. In this role, the incumbent will support the business process owner for the Complaint, CAPA and Deviation system and the associated governing local procedures and supporting processes, trending, metrics, and reports. This is a visible role with site responsibility and cross-functional influence that has impact on departmental performance and broad quality system management. The incumbent will be the subject matter expert across the site. Responsibilities • Manages the CAPA, Deviation, and Complaint Quality Systems for all GMP activities and works with responsible cross functional areas to ensure timely completion. • Support the Complaint, and CAPA and Deviation Forums, generate meeting minutes, follow up on action items and facilitate resolution when required. • Compiles applicable process metrics, identifies trends and escalates accordingly. • SME support during internal and health authority inspections of facility. • Communicates effectively with cross functional stakeholders on matters related to change control process. • Supports Quality Systems harmonization, automation, and improvement projects. Requirements • Must have experience with cGMP manufacturing, Quality, and Compliance. • Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions. • Must have basic understanding of continuous improvement and be able to improve the compliance and efficiency of the quality system. • Must be able to effectively prepare and convey data analysis insights to management and others within the group with clarity and accuracy. • Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes. • Requires moderate direction to complete more complex tasks. • Comfortable providing input/guidance to others within the department and across the organization in change control technical writing. • Propose solutions for issues and work with management to resolve. • Comfortable providing training/guidance to system users as needed, and in instructor-led settings. • Able to recognize conflict and notify management with proposed recommendations for resolution. • Able to prepare written communications and communicate problems to management with clarity and accuracy. • Able to support internal and health authority inspections of facility. Nice-to-haves • Familiarity with generating reports. • Experience supporting audits/inspections. Benefits • Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives. Apply tot his job