Shop-Floor QA Specialist for Continuous Quality Improvement

Fresenius Kabi USA; Kansas; On-site; USD 61,000 - 86,000; Full time

Job summary

Fresenius Kabi USA is seeking a Quality Assurance professional responsible for quality oversight and assistance to production processes on the shop floor, supporting departments and laboratories to ensure cGMP compliance and proper SOP adherence.

The role requires timely corrective actions for deviations, real-time documentation, and escalation to site management with proposed CAPAs, plus participation in 5S and continuous improvement initiatives.

Responsibilities

• Drive a culture of continuous quality improvement by on the shop-floor presence
• Act with competency, integrity and appropriately as Quality Assurance personnel and assure that the processes required are adhered to
• Authorized to stop production activities and contain materials and/or products with immediate effect where Critical Deviations are noted
• Escalate Isolated and Systemic issue to site management, including proposed CAPAs
• MQA shop-floor activities must cover the entire production and support processes which, depending upon the plant’s business operations will include but not limited to:
• Weighing and Dispensing verification
• Bulk Solution Preparation
• Component Preparation identification and verification
• Monitoring of In-Process Controls
• Oversight of Filling/Lyophilization activities (including completion of Aseptic Gouning Qualification)
• Finishing Activities, including Integrity Testing Verification, adherence of general inspection requirements/timelines, execution of sampling plan
• Performance of Visual Inspection (AQL)
• Packaging oversight
• Warehousing/Storage requirement adherence
• Monitoring of Facilities and Utilities per required parameters
• QA key contact to shop floor employees
• On the floor QA contact to elevate issues and provide real-time documentation requirements/trouble shooting analysis
• Participate in 5S activities
• Support in investigations & root-cause analyses (incidents & investigations)
• Shop-floor documentation review of MBRs and logbooks for GMP and procedural compliance
• Support quality and compliance and continuous Improvement projects
• Special oversight activities based on case by case demand to include but not limited to:
• media fills
• repackaging
• reworking
• validation/investigation study activities
• other duties as assigned

Job description

Fresenius Kabi USA is seeking a Quality Assurance professional responsible for quality oversight and assistance to production processes on the shop floor, supporting departments and laboratories to ensure cGMP compliance and proper SOP adherence.

The role requires timely corrective actions for deviations, real-time documentation, and escalation to site management with proposed CAPAs, plus participation in 5S and continuous improvement initiatives.