Skokie, Illinois, United States Job Description Job Title:
Process TechnicianJob Description The Process Technician supports clinical manufacturing operations by performing in-process checks, visual inspection, and packaging activities in compliance with cGMP, while also managing documentation, inventory, and SAP transactions. This role splits time between hands-on work in a clean room environment and desk-based documentation tasks to ensure high-quality, compliant production of aseptically filled units. Responsibilities + Perform in-process control ( IPC ) checks during filling activities to ensure all physical parameters meet established specifications. + Conduct visual inspection of filled and finished units, including vials, syringes, and related components, to identify and remove nonconforming products. + Verify correct labeling, sealing, and final packaging of each batch in accordance with cGMP and standard operating procedures (SOPs). + Ensure all activities follow current Good Manufacturing Practices (cGMP), Good Laboratory Practices ( GLP ), internal SOPs, and applicable regulatory requirements. + Perform calibration and routine maintenance of inspection and packaging equipment to maintain accuracy and reliability. + Package inspected batches according to defined procedures and documentation requirements. + Place and track orders in SAP to support production and packaging activities. + Ensure proper documentation and evaluation of process and inspection data, maintaining complete and accurate records. + Review batch records, inspection records, and related documentation for completeness, accuracy, and compliance. + Generate, update, and maintain SOPs and quality control (QC) forms in alignment with cGMP requirements. + Conduct inventory management activities, including monitoring stock levels of materials, components, and supplies used in production and inspection. + Collaborate with quality, laboratory, and manufacturing teams to support continuous improvement and maintain a high standard of product quality. Essential Skills + High school diploma (HS Diploma) with 1-2 years of experience in an FDA -regulated cGMP environment such as pharmaceutical, medical device, or food manufacturing. + Hands-on experience working in a laboratory or clean room environment. + Demonstrated understanding of FDA , cGMP, and GLP principles and their application in daily operations. + Ability to follow and apply SOPs and quality control procedures accurately and consistently. + Proficiency with Micro To view full details and how to apply, please login or create a Job Seeker account
