A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
) How will you make an impact? The Quality Control Inspector I will be responsible for all aspects of inspection (receiving, in-process and final). In addition, this position will provide QSR support for other QA activities such as calibration, environmental monitoring, product testing, label control, etc. What will you do? Receiving Inspection Receiving inspection of components following procedures, specifications and drawings. Utilize a variety of standard metrology equipment, including: Optical comparator, height gauge, master height gauge, CMM, Vision Metrology System (VMS, e.g., Smartscope), calipers, micrometers, surface table, gauge blocks, pin gauges, dial indicators, durometer, measuring microscope, hardness testers, pull force testers, surface roughness testers, etc. Read engineering drawings and interpret geometric dimensioning and tolerancing. Review associated paperwork, complete inspection records using good documentation practices, and release components. Program the Smartscope to run automatic routines for multiple part inspections. (Level 2 and higher) Write clear and concise procedures for inspection of components, machined tubing, etc. (Level 2 and higher) Carefully handle and process extremely small components without damaging them. In-Process Inspection Perform Line Clearance for Operations activities Inspect and release labeling Review device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures. Perform inspections on components and assemblies in manufacturing Final Inspection Review device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures. Perform final inspection on finished goods Inspect finished goods for proper labels, packaging, tamper seals and product in accordance with procedures. Coordinate final inspection activities with outside vendors, i,e, LAL, peel testing Perform in-house peel testing on sealed packages Maintain sample retain area Other Duties Work with engineering in the design of high quality inspection / metrology fixtures. Support equipment and process validation activities by inspecting process outputs Conduct periodic compliance audits of manufacturing operations and procedures for cGMP compliance. Ensures on a daily basis quality records and company practices are compliant with internal procedures and regulations. Coordinate the monthly environmental monitoring of the cleanrooms. Coordinate quarterly dose audits. How will you get here? High School Diploma required. 0-2 years industry experience. Knowledge, Skills, and Abilities Medical device experience and working knowledge of QSR a must Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable Attention to detail and accuracy a must Must have excellent documentation skills Team player, good written/oral communicator Must be organized and able to coordinate activities with outside vendors #GKOSUS
