Visual Inspection Program Lead – Parenteral

Fresenius Kabi; North Carolina; On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holidays and personal</

Health benefits: medical, dental and视n

Job summary

Fresenius Kabi is seeking a Visual Inspector Program Leader to design, develop, and implement visual inspection standards for parenteral products. You will ensure regulatory compliance, lead training, and collaborate with global teams on inspection initiatives and CAPAs.

The role requires expertise in both manual and automated visual inspection, with a focus on process optimization, risk-based strategies, and continuous improvement across the manufacturing network.

Responsibilities

• Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring regulatory compliance and industry best practices.
• Evaluate and validate visual inspection processes, including manual and automated methods, to achieve high quality outcomes.
• Establish risk-based inspection strategies for various parenteral products and materials.
• Harmonize inspection control strategies across internal and external manufacturing networks.
• Manage Defect kit implementation and defect catalogue with MQA.
• Serve as high-level knowledge on visual inspection processes, equipment, and quality standards.
• Conduct root cause analyses and implement CAPAs for quality events.
• Collaborate with QA, manufacturing, engineering, and TSMS to improve processes and reduce errors.
• Develop and deliver training programs for quality inspectors and operators; mentor junior staff.
• Ensure FDA and global regulatory compliance; keep documentation audit-ready; support internal and external audits.
• Explore new technologies, including AI, to enhance inspection accuracy and automation.

Job description

Fresenius Kabi is seeking a Visual Inspector Program Leader to design, develop, and implement visual inspection standards for parenteral products. You will ensure regulatory compliance, lead training, and collaborate with global teams on inspection initiatives and CAPAs.

The role requires expertise in both manual and automated visual inspection, with a focus on process optimization, risk-based strategies, and continuous improvement across the manufacturing network.