OPKO Diagnostics LLC is a division of OPKO Health, Inc., a publicly traded healthcare company involved in the discovery, development, and commercialization of proprietary pharmaceutical products and diagnostic technologies. OPKO Diagnostics is based in Woburn, Massachusetts, where we have developed and are commercializing a Point-of-Care diagnostic test system for use in physicians’ offices worldwide. This product will change the way medicine is practiced by allowing anyone to perform complex laboratory tests in any location, from the physician offices to a patient’s home.
OPKO seeks an individual with experience in a manufacturing/assembly environment. You will work in a team to manufacture our proprietary test cassettes. All manufacturing will take place in a regulated environment (FDA and ISO13485) using controlled procedures. Experience in a FDA regulated environment is an asset. The candidate will report to the Manufacturing Supervisor.
- Perform manufacturing operations to documented procedures
- Handle and visually inspect product (disposable test cassettes)
- Preform inspection under the microscope when required
- Operate equipment to apply adhesives and labels to parts
- Use pipettes to fill (aliquot) vials/tubes with reagents.
- Assist in implementation of quality system
- Accomplish goals under aggressive timelines and budgets
- High degree of dexterity; experience working on high-precision assemblies
- Completes daily production records
- Rejects products that are outside the specification
- Perform other assigned duties
Skills and Experience:
- The successful candidate must have demonstrated ability to perform in a fast-paced entrepreneurial environment
- Ability to stand/sit for a full shift and work on a high-volume manufacturing line for 8 hours
- Comfortable working in a clean room
- Strong written and verbal skills
- Proficiency in reading, writing and speaking English
- Ability to lift 35lbs or more when required
- Knowledge of 5S is a plus