Senior Quality Process EngineerLocationSt. Louis, MOJob DescriptionAs a Senior Quality Process Engineer, you'll play a pivotal role in maintaining top-tier quality standards at our St. Louis, MO plant. Responsibilities include overseeing the Annual Product Review (APR) program, managing investigations, and ensuring compliance with cGMPs.ESSENTIAL FUNCTIONS:Oversee and maintain the Annual Product Review (APR) program.Draft, review, and approve quality-related documents, such as Exceptions, OOSs, CAPAs, Customer Complaints, and Change Controls.Provide direct support during regulatory inspections and customer audits.Develop robust systems for cGMP compliance, document quality, and prompt issue resolution.Lead Root Cause Analysis and Process Improvement Teams.Report trends to management and ensure timely responses to audits/inspections.MINIMUM REQUIREMENTS:Experience:5+ years of Quality Assurance/Quality Control experience in pharmaceutical manufacturing.2+ years of managing investigations, OOS, CAPAs, and change controls.Proven project management history.Demonstrated expertise in root cause analysis.Bachelor of Science degree in Chemistry, Chemical Engineering, or a related science.Preferred Skills/Qualifications:Understanding of statistical principles and regulatory expectations.Proficiency in Minitab, BPCS, and TrackWise applications.Knowledge of cGMPs for APIs, including ICH Q7, CFR 210, and 211.CQE Certification.Proactive approach to change management.Strong issue identification and resolution skills.Effective relationship-building with partners.WORKING CONDITIONS:10% Laboratory exposure to hazardous compounds.10% Manufacturing environment exposure.80% Office environment, involving extended periods of sitting and computer use.100% onsite schedule.Base Salary: $90,000-$100,000