QA Floor Leader — GMP & Continuous Improvement

RXinsider LTD.; Kansas; On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in Kansas is seeking a Quality Assurance professional to support production processes, ensure SOP and cGMP compliance, and assist laboratories. You will identify deviations and recommend corrective actions, maintain sampling and retention samples, and act as a QA on the shop floor.

You will stop production when critical deviations occur, escalate issues for CAPA, and participate in 5S and investigations, contributing to continuous improvement and robust QA oversight across

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 Gowning 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

Skills

Quality Assurance

GMP compliance

CAPA execution

5S activities

Root cause analysis

Job description

Fresenius Kabi in Kansas is seeking a Quality Assurance professional to support production processes, ensure SOP and cGMP compliance, and assist laboratories. You will identify deviations and recommend corrective actions, maintain sampling and retention samples, and act as a QA on the shop floor.

You will stop production when critical deviations occur, escalate issues for CAPA, and participate in 5S and investigations, contributing to continuous improvement and robust QA oversight across