Quality Control Inspector
Step into a clean, climate-controlled environment in Rockford, IL where quality is more than a standardit's a mission. Here, you'll be part of a global effort to deliver life-changing therapies, with clear paths for growth, comprehensive benefits, and a team-driven culture that values your development. Join a workplace where stability, purpose, and opportunity come togetherbecause your work should matter, and your future should grow with it.
Quality Control Inspector 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
- 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
- Confirm package 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 company, cGMP (Current Good Manufacturing Practices), and GCP (Good Clinical Practices) policies and procedures