Quality Assurance

Job-ID32366924Reference26-00830

Provide training to new hires (FTEs) and/or Contractors Operate in a team-based environment with minimum supervision Supports 24/7 operations of the Distribution Center Monitor and review temperature data for the Distribution Center and ancillary areas Compliance oversight for the end-to-end Re-Pack-Re-Label processes, including, but not limited to Batch Record/Protocol activities Compliance oversight for the end-to-end clinical supply chain processes, including, but not limited to re-stickering and other labelling activities Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs Evaluate the overall compliance risk and recommending corrective actions and tracking progress Ensures compliance and remaining current with local, state, federal, and international regulations and standards Support of New Product Launch activities at the Distribution Center, including, but not limited to Master Data (sIDMa) set-upPerform gap assessments in local procedures to Pharmaceutical Global Standards, Business processes, and External Standards Identify business issues, communicates to management, prioritizes for action, and leads improvement opportunities and problem solutions in collaboration with other Supply Chain partners. Identifies opportunities to continuously improve quality, cost and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner Develop and review of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as needed Provide data/information/metrics to management for Quality System Management Reviews Notify/escalate critical quality issues to management in a timely manner Provide quality and compliance oversight for execution of Protocols Plans, support, and coordinates quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the duties personally Supporting internal and external audits Responsible for adhering to the Training process Responsible for adherence to the Records Management and Retention processes

A minimum of 2 years of experience in a highly regulated industry is required. Quality and Compliance experience in the Medical Device, Pharmaceutical or Consumer products industry and experience in distribution is preferred. Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required. Experience with Warehouse Management Systems and SAP is preferred. Experience with Quality Management Systems such as COMET is preferred. Proficiency in organizational and project management skills is preferred. Experience with Temperature Control is preferred. This position may require up to a 10% of domestic travel.