Justin Tokich

• Assemble in vitro diagnostic medical devices in accordance with approved manufacturing procedures.
• Able to operate machines for product manufacturing, including, but not limited to:

- Operation of free-dry chambers.

- Semi-automated Zebra printer, label, and barcode applicator machine's computer vision systems.

- Manual and semi-automated in-process inspection.

- Manual and semi-automated pouch printing.

- Manual lamination of cards (membrane, sample pad, absorbent pad).

• Able to perform automated membrane printing.
• Perform in-process quality checks on subassemblies and finished products.
• Maintain the identification and segregation of products, materials, labels, and other components.
• Maintain the cleanliness of workstations through line clearance procedures.
• Maintain accurate quality documentation related to quality, work in progress, test results, and special projects.
• Maintain production rates at assigned working stations.
• Ensure manufacturing conditions (temperature, humidity, and cleanliness) are maintained through proper attire and adherence to controlled room environment practices and procedures.
• Able to direct and relay assembly instructions to the team from the Manufacturing Supervisor.
• Able to verbally communicate line issues and suggestions for improvement with team members, other Lead Assemblers, Manufacturing Supervisors, etc.
• Establish and maintain awareness and knowledge of Good Manufacturing Practices (GMP), ISO13485, and Standard Operating Procedures (SOP); follow implemented procedures.
• Adhere to general safety rules, manufacturing procedures, regulations, and company policies.
• Responsible for compliance with the company's quality system requirements through training, and adherence to policies, procedures, and processes.

Quality Control:

• Responsible for compliance with the company's quality system requirements through training, and adherence to policies, procedures, and processes.
• Perform testing activities, and record testing results.
• Test and inspect the product using manufacturing and quality control procedures from batch record initiation through completed record filing.
• Ability to work independently.
• Review and address issues during standard procedures to maintain product quality.
• Understand all department-relevant SOPs and batch records.
• Accurate and precise in data entry, document organization, labeling, sample handling, and equipment operation.
• Perform standard protein chemistry procedures as required for making reagents, calibrators, controls, and components for immunoassays according to cGMP and ISOP guidelines.
• Maintain a safe and clean laboratory.