Manufacturing Visual Inspection

Position: Manufacturing Visual Inspection Location: Fremont, CA Duration: 12 Months Schedule: 2nd Shift, Monday-Friday, 2:00 PM-10:30 PM (40 hours/week) Candidates must successfully pass Vision Testing, including visual acuity and color blindness screening, before starting the assignment. Job Summary The Manufacturing Visual Inspection Associate executes routine unit operations in Visual Inspection related to the manufacturing of drug products in a multi-product facility. The position performs duties under limited supervision while following standard operating and manufacturing procedures. The role includes visual inspection, advanced visual inspection, palletizing, cleaning, inspection hood preparation, BioMES operations and exceptions, logistics coordination, batch record execution, equipment use log maintenance, work order initiation and tracking, and support of drug product filling and packaging activities. Key Responsibilities Execute routine visual inspection activities related to drug product manufacturing. Perform advanced visual inspection, palletizing, cleaning activities, and inspection hood preparation. Execute BioMES operations and manage exceptions. Provide support for drug product filling and packaging operations. Perform logistics coordination and support production projects. Execute and maintain batch records, equipment use logs, and work order tracking. Create and maintain training kits and related documentation. Document all activities in accordance with cGMP and cGDP requirements. Follow site regulations, SOPs, and manufacturing procedures. Report abnormalities and deviations accurately and in a timely manner. Maintain production areas according to established 5S standards. Adhere to safety standards and elevate unsafe conditions appropriately. Maintain training compliance and assist in training other technicians and associates when qualified. Support investigations, corrective actions, and other quality-related activities. Required Qualifications High School Diploma or GED required. Minimum one (1) year of experience in a GMP-regulated environment. Associate's or Bachelor's degree, or biotechnology vocational training, is preferred. Required Skills Visual Inspection Advanced Visual Inspection Inspection Hood Preparation Cleaning BioMES Operations and Exceptions Drug Product Filling and Packaging Batch Record Execution Equipment Use Logs Work Order Initiation and Tracking Manufacturing Execution Systems (MES) cGMP and cGDP Compliance Logistics Coordination Safety Standards Quality Activities Supporting Investigations Corrective Actions Strong written and verbal communication skills Ability to read and understand SOPs and manufacturing instructions Ability to perform detailed, quality-focused work Ability to document work accurately Ability to work within a high-performing team environment Physical Requirements Position requires regular physical activity, including standing and working in a manufacturing environment. Lifting requirements may vary based on production activities and are typically up to 25 pounds. #J-18808-Ljbffr Aequor