Quality Specialist

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/13720175 Shift: 1st, 2nd or 3rd or 12 Hour Weekend Nights Hours: 7:00am - 3:00pm (Monday - Friday), 3:00pm - 11:00pm (Monday - Friday), 9:00pm - 7:00am (Monday - Thursday) or 7:00pm - 7:00am (Friday - Sunday) Help ensure the quality, safety, and integrity of life-changing medications. We\'re looking for a Quality Auditor in Rockford, IL to provide hands-on production floor support, verify cGMP compliance, audit manufacturing processes, and drive continuous improvement. This role is ideal for someone who enjoys solving problems, collaborating with operations, and making a measurable impact in a highly regulated pharmaceutical manufacturing environment. Quality Specialist Responsibilities include but are not limited to:\ - Perform production room approvals after product and lot changes\ - Verify first piece inspection to ensure finished goods code, format, and expiration date are correct\ - Ensure equipment is packaged within validated parameters and equipment calibration dates on all process equipment are within required specifications. If not, this individual will contact the appropriate personnel to recalibrate and/or remediate the issue\ - Review batch record to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately. Conduct periodic checks to confirm hourly inspections are being performed correctly and on track to meet requirements\ - Review sampling pages to ensure samples have been taken, labeled and documented appropriately\ - Audit production room to ensure Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks have been completed accurately and timely\ - Confirm package (unit) functionality (perfs, peel, push, seals, etc.)\ - Check to ensure portable equipment has been cleaned and documented correctly on quality form\ - Audit production personnel to ensure the job is performed safely including wearing required personal protective equipment\ - Ensure recovery stations are segregated from product flow\ - Confirm bulk material and components for job are correct and kept covered\ - Review each equipment clean room logbooks for correct clean room, entries are complete, correct and legible\ - Review temperature and humidity data to ensure within acceptable job parameters\ - Document audits using the Quality Auditor checklist listing the room, production job description, and date when the audit was conducted\ - Identify proactively gaps in batch records and to mitigate deviations and documentation errors\ - Participate on improvement teams (i.e. FMEAs, Kaizen, batch record etc.) as needed\ - Support Root Cause Analysis as needed\ - Ensure 5s (Sort, Set in order, Shine, Standardize, Sustain method) Compliance\ - Adhere to cGMP (Current Good Manufacturing Practices), and GCP (Good Clinical Practices) policies, procedures, rules