The Manufacturing Associate will report to the Director of Manufacturing.
Cleveland Diagnostics is a dynamic and innovative company dedicated to the development of cutting-edge diagnostic solutions. We are committed to improving healthcare through the creation of highly accurate and reliable diagnostic tests. We foster a collaborative and supportive team environment where individuals can grow and contribute to meaningful scientific advancements.
We are looking for a motivated and detail-oriented Manufacturing Associate to join our growing team. This is an entry-level position ideal for candidates eager to begin or build a career in biotechnology manufacturing. Working under close supervision and following established procedures, the Manufacturing Associate will support day-to-day production activities such as reagent formulation, filling, assembly, packaging, material handling, and basic in-process quality checks. The successful candidate will learn and apply Good Manufacturing Practices, maintain accurate documentation, and adhere to all safety and quality standards. This position requires a strong willingness to learn, reliability, attention to detail, and the ability to follow instructions in a dynamic, high-throughput, and highly regulated manufacturing environment. Full on-the-job training will be provided.
Formulation, filling, and packaging of Class III medical devices according to SOPs, work instructions, and product specifications, ensuring compliance with GMP, FDA, and ISO 13485 standards.
Operate and maintain production equipment and perform material staging, line setup, changeovers, and cleaning procedures.
Assist in preventive maintenance, equipment calibration support, and basic troubleshooting of equipment.
Maintain clean, organized, and compliant work and storage areas, following cleanroom protocols, PPE requirements, and safety guidelines.
Support adherence to environmental and hazardous waste handling requirements as outlined by local and federal regulations.
Receive, inspect, label, and store raw materials and components, ensuring accurate lot control, FIFO/FEFO usage, and traceability in accordance with inventory procedures.
Issue and return materials to/from production using inventory management systems, maintaining real-time inventory accuracy and proper documentation.
Conduct physical inventory counts, cycle counts, and material reconciliations of the raw materials and components.
Conduct the preparation of finished products for shipment, including packing, labeling, and ensuring that all items are ready for transportation.
Coordinate shipping, ensuring the correct materials are shipped on time to meet customer requirements.
Assist in the creation, revision, and control of SOPs, work instructions, and training documents to ensure they reflect current processes and regulatory requirements.
Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) by completing accurate, timely, and legible documentation (e.g., logbooks, device history records).
Assist in identifying, documenting, and escalating non-conformances (NCRs) and supporting root cause investigations and Corrective/Preventive Actions (CAPAs).
Support internal and external audits by preparing documentation, maintaining inspection readiness, and answering auditor queries.
Contribute to lean manufacturing initiatives, such as 5S, waste reduction, and process optimization, to enhance product quality and reduce downtime.
Other duties as assigned.
