Manufacturing QMS Specialist- 238350 Job at Medix™, Chicago, IL

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  • Medix™
  • Chicago, IL

Job Description

Position: Manufacturing QMS Specialist

Location: Chicago, IL

Employment Type: Full-time, Exempt

Duration: Contract-To-Hire

Shift: Monday-Friday 8:30am-5pm, but flex to stay late if/when needed

Position Summary

We 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 Responsibilities

  • Manage 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 (<10%) and ensure compliance with company policies and regulations.

Qualifications

  • Experience 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.

Job Tags

Full time, Contract work, Flexible hours, Shift work, Monday to Friday,

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