Visual Inspection Program Leader

Fresenius Kabi USA•Wilson, NC

6d•$73,614 - $103,528

About The Position

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.

Requirements

High-level knowledge in automated and manual visual inspection.
Experience with parenteral products.
Knowledge of regulatory requirements and industry best practices.
Experience with Knapp studies and Defect level tracking.
Ability to train and qualify operators.
Experience with root cause analyses and CAPAs.
Experience collaborating with cross-functional teams (QA, manufacturing, engineering, TSMS).
Experience developing and delivering training programs.
Experience with FDA and global regulatory standards.
Experience participating in internal and external audits.
Experience with development and maintenance of internal quality system documents.
Experience with validation reports and PoDs.
Experience exploring new technologies and methodologies in visual inspection, including AI.
Experience identifying opportunities for process automation.

Responsibilities

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.
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.
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.
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.
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.