Roles & Responsibilities:
" Quality and compliance product receiving process, including, but not limited to receiving inspection activities such as review of temperature monitoring devices and systematic transactions in Warehouse Management System and/or SAP.
" Monitoring and following Quarantine/Hold/Stop-Ship/Recall processes and notices.
" Product refusals process activities, including, but not limited to inspection and disposition.
" Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.
" Responsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes.
" Interface collaboratively with other business partners and stakeholders.
" 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-up.
" Perform 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.
Education & Experience:
" A minimum of bachelor's degree in an Engineering, Life Science, and Technical scientific or related discipline is preferred. In absence of a bachelor's degree, special consideration would be considered for individuals who have related and background experience.
" 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.