Senior Visual Inspection Program Leader

Fresenius Kabi USA; Wilson (NC); On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Health benefits (medical, dental, and,

Vision coverage

Paid vacation, holiday and personal  

Job summary

The Fresenius Kabi USA Visual Inspector Program Leader will design, develop, and implement visual inspection standards for parenteral products, ensuring regulatory compliance and alignment with FK SOPs. It leads automated and manual inspection efforts and trains operators.

Responsibilities include process optimization, CAPAs, mentoring staff, and supporting audits to maintain a robust quality system across global and local operations. Competitive salary and benefits accompany the role.

Qualifications

• High level knowledge of visual inspection processes for parenteral products.
• Experience in regulatory compliance and GMP requirements.
• Ability to lead cross functional teams and training programs.

Responsibilities

• Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring regulatory compliance.
• Evaluate and validate visual inspection processes, including manual and automated methods.
• Establish risk-based inspection strategies for different parenteral products.
• Harmonize visual inspection control strategies across the manufacturing network.
• Manage Defect kit implementation and defect catalogue with MQA.
• Serve as high-level knowledge on visual inspection processes, equipment, and standards.
• Conduct root cause analyses and implement CAPAs for quality events.
• Collaborate with QA, manufacturing, engineering, TSMS to improve processes.
• Develop and deliver training programs for quality inspectors and operators.
• Mentor junior staff and develop training materials.
• Ensure FDA and global regulatory compliance; audit readiness.
• Participate in audits and support inspection-related findings.
• Develop and maintain internal quality system documents and validation reports.
• Explore new technologies and automation opportunities in visual inspection.

Job description

The Fresenius Kabi USA Visual Inspector Program Leader will design, develop, and implement visual inspection standards for parenteral products, ensuring regulatory compliance and alignment with FK SOPs. It leads automated and manual inspection efforts and trains operators.

Responsibilities include process optimization, CAPAs, mentoring staff, and supporting audits to maintain a robust quality system across global and local operations. Competitive salary and benefits accompany the role.