Job Description: The cGMP QC Technician reports to the cGMP Manager, and the QC Supervisor. Once fully trained, this individual will have the ability to work independently while performing specialized techniques in an FDA-regulated cGMP Core Lab. The primary job will be reagent/supply ordering & test cellular based products for quality and ship investigational cellular products for therapeutic use in human phase I clinical trials The cGMP QC Technician assures all activities in the lab complies with Federal, State and local regulations and policies. Core Functions: • Performs specialized quality tests on manufactured products for use in human phase I clinical trials. • Performs new method development & qualification as needed. • Creates SOPS, lab forms as needed. • Assists in the release of manufactured products to clinic. • Assists QC during environmental monitoring activities. • Assists in inventory check-in, documentation, and proper storage of reagents. To maintain adequate materials and reagents used for manufacturing and quality testing of cellular products using in human phase I clinical trials. • Prioritizes and adjusts workflow and schedules to meet demands of multiple projects, and assure that necessary supplies are available. • Ensures all activities in the lab comply with federal, state, and local regulations and policies. • Responsible for laboratory records, equipment records, materials check-in records and all quality documents related to job function while adhering to cGMP, GLP and GDP. • Assists in inventory check-in, documentation, and proper storage of reagents. • Assists with revalidating existing analytical methods and procedures. • Involves working long hours in a clean room with restrictive gowning. • Assume other job duties as assigned. Cross training as a Manufacturing technician may also occur, however those activities will be separated from any manufacturing responsibilities so that these duties will not overlap and will follow the Manufacturing technician job responsibilities.

As a vertically integrated company, we specialize in the design, development, and production of medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for the vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. CNC Machinist responsibilities: • Prepare and operate machines to perform tasks such as drilling, grinding, milling etc. • Understand specifications of the task at hand and the desired result by reading blueprints, mechanical drawings etc. • Translate instructions into computer commands so the machines can perform the correct function • Prepare and load raw materials onto the machines • Set up and run first pieces to verify that the machines produce outputs according to specifications • Supervise the machines while they execute the tasks and make any necessary adjustments to produce a better result • Inspect and measure finished products and compare them with requirements to determine if the process has been completed properly