Manufacturing Associate

Our team is growing, and we currently have an immediate opening for a Manufacturing Associate

Manufacturing Associate

Onsite-Cleveland Office

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.

• Associate degree in Engineering Technology, Life Sciences, Manufacturing, or a related technical field is a plus.
• No prior experience required; 0–1 years of experience in a manufacturing, warehouse, laboratory, or production environment is preferred.
• Exposure to FDA, ISO 13485, or GMP-compliant environments is a plus but not required.

• Willingness and ability to learn FDA…