Quality Specialist
Nipro Renal Solutions USA, CorpOverview The Quality Manufacturing Specialist is responsible for label control activities, incoming inspection and receiving materials, management of nonconforming materials, and maintenance of labeling equipment. This role ensures that raw materials, packaging components, and labels meet established quality requirements prior to release for use and supports compliance with quality system procedures and regulatory requirements. Duties Print and proofread product labels to ensure accuracy and compliance with approved specifications and labeling requirements. Maintain label inventory, including issuance, reconciliation, storage. Coordinate ordering of label stock with purchasing department to support production schedules. Perform incoming inspections of raw materials, packaging materials, and label stock in accordance with approved procedures and specifications. Review receiving documentation, certificates of analysis, and related records to verify compliance with acceptance criteria. Document inspection results and material status accurately and in a timely manner. Initiate and process nonconformance reports for raw materials, packaging components, and label stock that do not meet specifications. Assist in the management of Material Review Board (MRB) inventory, including segregation, identification, and disposition of nonconforming materials. Ensure appropriate labeling and control of materials placed on hold or awaiting disposition. Perform routine preventive maintenance and cleaning of label printers and related equipment. Maintain equipment maintenance logs and report equipment issues requiring repair or service. Skills High school diploma or equivalent required; Associate degree in a scientific, technical, or related field preferred. Minimum of 1-2 years of experience in a quality, manufacturing, warehouse, or regulated production environment preferred. Experience with inventory control, receiving activities, or label control is preferred. Experience working in a medical device, pharmaceutical, or other regulated industry is desirable. Knowledge of quality systems, Good Documentation Practices (GDP), and material control processes. Ability to read, interpret, and follow specifications, procedures, and work instructions. Strong attention to detail and accuracy when reviewing labels and inspection documentation. Effective organizational and time management skills. · Basic problem solving and investigative skills. Ability to communicate effectively and work collaboratively with quality, operations, warehouse, and supply chain personnel. Ability to manage multiple tasks and priorities in a fast paced environment. Physical Requirements: Ability to stand, walk, and move throughout warehouse and production areas for extended periods. Ability to independently lift and carry materials weighing up to 50 pounds on an occasional basis. Ability to perform visual inspections, including reading small print and identifying defects or discrepancies. Ability to operate office equipment, computers, label printers, and inspection tools. Expected hours: 40.0 per week Benefits: 401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Life insurance Paid time off Vision insurance Work Location: In person