Fresenius Kabi USA
VISUAL INSPECTION PROGRAM LEADER - 1st Shift
Fresenius Kabi USA, Grand Island, New York, United States
VISUAL INSPECTION PROGRAM LEADER – 1st Shift
Job Summary:
Responsible for the management of the inspection activities, which include Manual Visual Inspection, Semi‑automated Visual Inspection, and Automated Inspection processes. Functions as the site Subject Matter Expert for these processes. Responsible for establishing and maintaining robust programs for the inspection processes in accordance with cGMP practices. The position works independently and is responsible for maintaining the visual inspection qualification and re‑qualification program for all personnel qualified to inspect incoming components and semi‑finished and finished product. Provides the necessary leadership to ensure the success of the inspection programs by establishing proper partnership with site team leadership. Performs analysis on quality and manufacturing indicating data and recommends actions for compliance and process improvement.
Responsibilities
Supervises, maintains, and operates the visual inspection training center.
Serves as Subject Matter Expert of defect types and classifications for products.
Ensures robust programs are established and maintained for 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.
Provides oversight of the qualification and re‑qualification of inspectors and QA personnel.
Completes all documentation associated with the qualification and re‑qualification of personnel.
Develops and quality‑assesses equipment challenge kits and inspector qualification test kits.
Maintains a regulatory inspection readiness program for the inspection processes.
Reviews and approves changes, SOPs, master batch records, and deviations associated with inspection processes.
Works cross‑functionally to execute strategy and ensure execution of the Visual Inspection program across multiple groups.
Reviews unusual defects and aids in the classification of these defects.
Assists with the creation of KNAPP studies and administers them to inspectors.
Mentors junior staff and develops training materials to promote inspection skills and quality awareness.
Performs supplemental investigations/projects as required by senior management.
Performs other duties as directed by management.
Requirements
Bachelor’s degree in a technical field, or equivalent combination of education, experience and training.
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.
Ability to understand and interpret data utilizing analytical skills and practical experience in pharmaceutical application.
Demonstrated leadership and decision‑making qualities.
Technical knowledge of inspection related processes, process and equipment validation preferred.
Computer skills required.
Excellent verbal and written communication skills.
Formal or technical leadership experience.
Experience with regulatory guidelines (FDA, EMA, ICH) and regulatory inspections.
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401(k) with company contribution, and wellness 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.
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Responsible for the management of the inspection activities, which include Manual Visual Inspection, Semi‑automated Visual Inspection, and Automated Inspection processes. Functions as the site Subject Matter Expert for these processes. Responsible for establishing and maintaining robust programs for the inspection processes in accordance with cGMP practices. The position works independently and is responsible for maintaining the visual inspection qualification and re‑qualification program for all personnel qualified to inspect incoming components and semi‑finished and finished product. Provides the necessary leadership to ensure the success of the inspection programs by establishing proper partnership with site team leadership. Performs analysis on quality and manufacturing indicating data and recommends actions for compliance and process improvement.
Responsibilities
Supervises, maintains, and operates the visual inspection training center.
Serves as Subject Matter Expert of defect types and classifications for products.
Ensures robust programs are established and maintained for 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.
Provides oversight of the qualification and re‑qualification of inspectors and QA personnel.
Completes all documentation associated with the qualification and re‑qualification of personnel.
Develops and quality‑assesses equipment challenge kits and inspector qualification test kits.
Maintains a regulatory inspection readiness program for the inspection processes.
Reviews and approves changes, SOPs, master batch records, and deviations associated with inspection processes.
Works cross‑functionally to execute strategy and ensure execution of the Visual Inspection program across multiple groups.
Reviews unusual defects and aids in the classification of these defects.
Assists with the creation of KNAPP studies and administers them to inspectors.
Mentors junior staff and develops training materials to promote inspection skills and quality awareness.
Performs supplemental investigations/projects as required by senior management.
Performs other duties as directed by management.
Requirements
Bachelor’s degree in a technical field, or equivalent combination of education, experience and training.
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.
Ability to understand and interpret data utilizing analytical skills and practical experience in pharmaceutical application.
Demonstrated leadership and decision‑making qualities.
Technical knowledge of inspection related processes, process and equipment validation preferred.
Computer skills required.
Excellent verbal and written communication skills.
Formal or technical leadership experience.
Experience with regulatory guidelines (FDA, EMA, ICH) and regulatory inspections.
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401(k) with company contribution, and wellness 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.
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