VISUAL INSPECTION PROGRAM LEADER - 1st Shift

• Supervises, Maintains, and operates the visual inspection training center.
• Subject Matter Expert of defect types and classifications for products with understanding of defect levels obtained in the production areas.
• Subject Matter Expert for Manual Visual Inspection, Semi-automated Visual Inspection and Automated Inspection processes.
• Ensures robust programs are established and maintained for the inspection processes in compliance with cGMPs.
• Establishes new or refines existing processes and procedures for manual, semi-automated and automated inspections in accordance with cGMP practices.
• Ensures processes and procedures are aligned with regulatory requirements.
• Provides oversight and administration of the manual visual inspection and the semi-automated visual inspection qualifications of inspectors and required Quality Assurance personnel to ensure qualifications are performed within procedural requirements and in a consistent manner.
• Completes all documentation associated with the qualification and re-qualification of personnel.
• Provides oversight on the development, creation and qualification of equipment challenge kits and inspector qualification test kits to ensure challenging of equipment and inspector qualifications are conducted correctly for all product types (i.e. liquid and lyophilized).
• Maintains a regulatory inspection readiness program for the inspection processes.
• Reviews and approves changes or implementation of SOPs and master batch record associated with the inspection processes. Reviews and approves deviations associated with events related to the inspection processes.
• Works as a member of a cross-functional team to execute strategy and ensure execution of the Visual Inspection program across multiple groups (production and quality groups).
• Reviews unusual defects and aids in the classification of these defects.
• Assists with the creation of KNAPP studies and administers them to inspectors.
• Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization.
• 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.
• Performs supplemental investigations/projects as required by senior management.
• Performs other duties as directed by management.

• Bachelor's degree in a technical field, or combination of education, experience and training in field
• At least five years of experience working in a manufacturing environment in quality or aseptic procedures
• Extensive knowledge of legal and regulatory requirements governing the manufacture of pharmaceutical products
• Must be able to understand and interpret data utilizing analytical skills and practical experience in pharmaceutical application
• Demonstrate leadership and decision-making qualities
• Technial knowledge of all inspection related processes, process and equipment validation preferred
• Computer skills required
• Excellent verbal and written communication skills required
• Formal or technical leadership experience
• Experience with regulatory guidelines (FDA, EMA, ICH) and experience with regulatory inspection

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.

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.