Visual Inspection Program Leader

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

Job Summary

The Visual Inspector Program Leader is responsible to Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements, industry best practices and FK local and global SOP's. Acts as high-level knowledge in automated and manual visual inspection. Collaborates with local and global teams for all Visual Inspection initiatives including Knapp studies, Defect level tracking, and visual inspection control strategy. Responsible for training and qualifying operators.

Salary Range: $73,614 - $103,528

Position is eligible to participate in a bonus plan with a target of 6% of the base salary.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT:

Visual Inspection Program Development

• Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices.
• Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes.
• Establish risk-based inspection strategies for different types of parenteral products and materials (e.g., vials, syringes).
• Harmonize visual inspection control strategies and practices across the internal and external manufacturing network.
• Manage Defect kit implementation process.
• Manage Defect catalogue and Library in collaboration with MQA.

Technical Expertise & Process Optimization:

• Serve as the high-level knowledge on visual inspection processes, equipment, and quality standards for the parenteral product line.
• Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality related events.
• Collaborate with cross-functional teams (QA, manufacturing, engineering, TSMS) to identify and implement process improvements that enhance efficiency and reduce inspection errors.

Training & Development:

• Develop and deliver training programs for quality inspectors, operators, and other relevant staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements.
• Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization.

Compliance & Documentation:

• Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection processes and documentation up-to-date and audit-ready.
• Participate in internal and external audits, providing expert insights and support for any inspection-related findings.
• Act as high level knowledge for the development and maintenance of internal quality system documents (Global Q standards, Common Q practices) and execution documents (validation reports, PoDs) to support the visual inspection Quality System.

Innovation & Continuous Improvement:

• Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency.
• Identify opportunities for process automation, working closely with engineering teams to implement new tools and technologies.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.