Senior Quality Engineer, Risk Management
$78,500–$141,000 year
Hybrid · North Chicago, Illinois, United States
Job Summary
Senior Quality Engineer, Risk Management supporting TPM plants and PQA functions. Responsible for QA activities including approval of manufacturing directions to production, investigations of manufacturing, laboratory and raw material events, product impact analyses, and CAPAs. Evaluates supplier change notifications, monitors process tracking and trending, and performs annual Product Quality Reviews. Acts as liaison between regulatory areas and TPM sites for regulatory submissions. Maintains compliance with cGMP and QA procedures; reviews and approves manufacturing directions; supports global projects with risk analysis and implementation; conducts thorough investigations and ensures proper documentation. Requires knowledge of GMP regulations, strong analytical and communication skills, and experience with SAP/LRMS. Bachelor’s degree in Engineering or Science and six years of pharmaceutical operations experience are preferred. Eligible to participate in company benefits and incentive programs.
Required Qualifications
- Bachelor’s degree in Engineering or Science
- Six years of experience in Pharmaceutical operations
- Knowledge of GMP regulations and standards
- Strong analytical skills
- Experience with SAP and LRMS (preferred)
Desired Qualifications
- Bachelor’s degree in Engineering or Science
- Six years of experience in Pharmaceutical operations
- Knowledge of GMP regulations and standards
- Strong analytical skills
- Experience with SAP and LRMS (preferred)
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