Manufacturing Associate
Harmans, Maryland, United States
Lean Six Sigma Yellow BeltPerforms Processing Steps and Manufacturing Support activities, monitoring process against the batch record; as well as Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks. Understand basic cGMP requirements and follow those requirements, including requirements for good documentation practices. Completes /reviews validation protocols, deviation reports, and change controls per cGMP’s. Performs the weighing, and dispensing of raw materials for media and buffersPerforms the preparation of small and large-volume media and buffer solutions, filtration, and product transfer. Operates benchtop equipment including pH, conductivity, Osmo meters, pumps, tubing welders, filter integrity testers, etc. Dispensing, labeling, transfer/staging of raw materials and parts. Assembly/disassembly, cleaning, and sterilization of components, parts, and equipmentMaintaining equipment, area, and cleaning logbooks. Cleaning and sanitizing production rooms and equipment. Stocking production and cleaning supplies. Author/ review/improve SOPs, batch records, protocols, and technical reports. Actively participates in training activities, managing their training plan.