Quality Control Specialist
Medical Devices Manufacturing · Plymouth, MN
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Laboratory-based Specialist responsible for sample handling, preparation, analytical testing, instrument operation, and accurate data documentation. The role focuses on detecting/quantifying cellular and particulate targets while distinguishing them from interferents such as RBCs, fungal elements, and lipids.
Key Responsibilities
Receive, label, prepare, and process fluid/process samples following SOPs and chain-of-custody requirements.Perform wet-lab/analytical testing to detect and quantify cellular or particulate targets.Identify and document RBCs, fungal elements, lipids, and other testing artifacts/interferents.Perform instrument setup, calibration/verification, and basic troubleshooting.Maintain complete laboratory records, raw data, calculations, and observations.Log sample details for trending, including sample material, tubing size/configuration, sample age, storage conditions, and freeze/thaw information.Support investigations and method/process improvements.Follow GDP, GLP, biosafety, PPE, and quality procedures.Must-Haves: Hands-on laboratory/sample handling experience, wet-lab or analytical testing skills, strong documentation/data logging, ability to follow SOPs/GDP/GLP, comfort handling biological fluids, and strong attention to detail.Education/Experience: Associate degree or higher in Biology, Chemistry, Laboratory Science, Medical Laboratory Technology, or related field. 1+ year lab experience preferred, but strong entry-level candidates with relevant laboratory coursework can be considered. LIMS/ELN experience is a plus.