Manufacturing QMS Specialist- 238350

** Manufacturing QMS Specialist Chicago, ILEmployment ** Full-time, Exempt* Contract-To-Hire** Monday-Friday 8:30am-5pm, but flex to stay late if/when neededPosition SummaryWe are seeking a detail-oriented Manufacturing QMS Specialist to join our team in Chicago, IL. This role supports the manufacturing team through quality management system (QMS) documentation, including reviewing and authoring deviations, change controls, investigation reports, executed batch records, SOPs, and CAPAs. This position requires an understanding of drug product manufacturing, packaging, and biologics processes.Key ResponsibilitiesManage manufacturing documentation, track change controls, deviations, and CAPAs, and ensure timely QMS closure. Author batch records, SOPs, and GMP documents for QA and regulatory inspections. Provide on-floor support during critical campaigns (QualificationsExperience with batch record review, SOP writing, CAPAs, deviations, and investigations.Knowledge of GMP batch manufacturing and packaging documentation.Basic computer proficiency (Word, Excel, spreadsheets).Understanding of regulatory compliance and document control.

Created: 2025-03-08