Supplier Quality Specialist

Duration :-12 monthsDescription:The Quality Analyst is responsible for the oversight and execution of Quality Management Systems and compliance at the Distribution Center. The Quality Analyst serves as a single point of contact to the Sr. Manager, Commercial Quality and Supply Chain partners on compliance related matters and is the liaison with multiple Quality and Compliance organizations to drive timely resolution of quality and compliance related issues. The Quality Analyst identifies business issues, identifies opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions. The Quality Analyst implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.You will be responsible for: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 SAPMonitoring and following Quarantine/Hold/Stop-Ship/Recall processes and noticesProduct refusals process activities, including, but not limited to inspection and dispositionServe 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 issuesResponsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management SystemsResponsible for adherence to the Records Management and Retention processesResponsible for adhering to the Training processSupporting internal and external auditsPlans, support, and coordinates quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the duties personallyProvide quality and compliance oversight for execution of ProtocolsNotify/escalate critical quality issues to management in a timely mannerProvide data/information/metrics to management for Quality System Management ReviewsDevelop and review of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as neededDrives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe mannerIdentifies opportunities to continuously improve quality, cost and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectivesIdentify business issues, communicates to management, prioritizes for action, and leads improvement opportunities and problem solutions in collaboration with other Supply Chain partners.Perform gap assessments in local procedures to Johnson and Johnson Global Standards, Business processes, and External StandardsSupport of New Product Launch activities at the Distribution Center, including, but not limited to Master Data (sIDMa) set-upEnsures compliance and remaining current with local, state, federal, and international regulations and standardsEvaluate the overall compliance risk and recommending corrective actions and tracking progressResponsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needsCompliance oversight for the end-to-end clinical supply chain processes, including, but not limited to re-stickering and other labeling activitiesCompliance oversight for the end-to-end Re-Pack-Re-Label processes, including, but not limited to Batch Record/Protocol activitiesMonitor and review temperature data for the Distribution Center and ancillary areasSupports 24/7 operations of the Distribution CenterOperate in a team-based environment with minimum supervisionProvide training to new hires (FTEs) and/or ContractorsInterface collaboratively with other business partners and stakeholdersQualifications / Requirements: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.Location can be Shepherdsville, KY or Somerset, NJAbout US Tech Solutions:US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit (.US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Recruiter Details:Name: I.Prudvi kumarEmail: Internal Id: 26-04181

Created: 2026-03-04