Visual Inspection Program Leader

Fresenius Group; Wilson, Northern (NC, KY); Híbrido; USD 74 000 - 104 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) plan with company contributions

Paid vacation

Holidays and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Resumo da oferta

Fresenius Kabi in Wilson, NC seeks a Visual Inspector Program Leader to design, develop, and implement visual inspection standards for parenteral products, ensuring regulatory compliance and industry best practices. You will provide high-level expertise in automated and manual inspection and collaborate with global teams.

The role emphasizes training and qualifying operators, maintaining defect catalogs, and supporting quality systems, with a focus on reducing inspection errors and enabling

Qualificações

• Experience with GMP and FDA regulatory requirements.
• Ability to train and qualify inspectors.
• Collaborate with QA, manufacturing, and engineering teams.

Responsabilidades

• Lead the design, development, and implementation of visual inspection standards for parenteral products with regulatory compliance.
• Evaluate and validate visual inspection processes (manual and automated) to achieve quality outcomes.
• Establish risk-based inspection strategies for parenteral products and materials.
• Harmonize inspection control strategies across networks.
• Develop and deliver training programs for quality inspectors and operators.
• Ensure audit readiness and maintain documentation for quality systems.
• Drive continuous improvement and process automation opportunities with engineering.

Descrição da oferta de emprego

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 andvision coverage, as well as life insurance, disability, 401K with company contribution,and wellness program.

Please note that joining our team does not create a guaranteed or permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.