Manufacturing Associate

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

Title

Manufacturing Associate

Location

Onsite-Cleveland Office

Reports To

The Manufacturing Associate will report to the Director of Manufacturing.

Company Overview

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.

Job Overview

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.

Essential Responsibilities and Duties

• 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.

Qualifications

• 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.

Physical Requirements/Working Conditions/Equipment used:

• Willingness and ability to learn FDA regulations (21 CFR Part 820), ISO 13485, GMP, and GDP standards.
• Ability to read, understand, and follow SOPs, work instructions, and product specifications.
• Strong attention to detail and a commitment to accurate documentation.
• Ability to follow directions and work effectively as part of a team in a fast-paced environment.
• Reliability, dependability, and a strong work ethic.
• Basic math and computer skills (e.g., Microsoft Office 365).
• Good verbal and written communication skills.
• Ability to stand, walk, and perform repetitive tasks for extended periods.
• Lift and move up to 35–50 lbs as needed.
• Work in cleanrooms or controlled environments requiring gowning and strict hygiene practices.
• Able to climb stairs in case elevator out.
• May be exposed to hazardous chemicals, biohazards, radioactive materials, etc.
• Position is on-site, this is NOT a remote or hybrid position; candidate must have ability to maintain punctual daily in-person attendance

Other Requirements

• Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples).

Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

Cleveland Diagnostics offers an extremely robust benefits package which includes:

• 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
• 100% Employer-paid Dental & Vision for entire family
• No cost for employee coverage for Group Term Life, Short & Long Term Disability
• 4% retirement contribution Employer match
• Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
• Paid Family Leave Program
• Generous PTO plan & holiday program
• Flexible work schedule & lucrative employee referral program
• Salary range may vary by work state/geographical region/territory
• Easy to get to office location with newly built-out office space
• Free coffee, snacks and other goodies all day long

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.

Compensation details: 21.63-24.04 Hourly Wage

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