This position is responsible for overseeing KBI Finished Products, supporting the Product Distribution Release, and managing the Product Returns process. The position also involves providing support for quality tasks related to KBI’s contract manufacturing organizations (CMOs) and contributing to KBI’s Quality Management system initiatives.

Product Distribution and Product Returns

Manage and maintain the product distribution releases processEstablish and maintain a Product Returns Program for assigned product lines, ensuring compliance with current laws and regulations.Serve as a liaison with KBI 3rd Party Logistic team and distributors.Collaborate closely with Logistics and Quality staff to resolve quality issues related to manufactured and/or distributed products.Collaborate closely with KBI Logistic and Commercial Team.Manage and support quality events for distributed products 

Quality Assurance

Support management of the quality system for the KBI Fort Lee site.Manage Nonconformance, Investigations and CAPA implementation.Support quality activities for KBI CMO products and KBI licensed products.Manage and support Global and ROW quality activities and tasks, as assignedManage and support internal/external audits, and inspections as assigned.Develop and manage internal procedures in compliance with industry standards Establish and maintain the Product Complaints Program, in compliance with current laws and regulations.Perform other duties and special projects, as assigned

Contract manufacturers (CMO)

Support day-to-day activities, as the Quality representative, with KBI CMOs

Artwork Management 

Manage and maintain labeling and artwork for assigned product lines.Ensure label content meets corporate, Regulatory, and FDA requirements.Work closely with graphics and print vendors.Interpret governmental regulations and have a basic understanding of the requirements for pharmaceutical product labeling

Requirements:

Bachelor's Degree in Engineering, Biochemistry, Biology or equivalent discipline.Minimum 5 years relevant CGMP experience within pharmaceutical industry with quality auditing and pharmaceutical label control experienceStrong knowledge of Master Control preferredStrong knowledge and experience in the manufacture and control of biologics, sterile product manufacturingExcellent verbal and written skillsDemonstrated ability to work as a team member and to exercise independent decision makingAbility to be proactive and demonstrated ability to implement continuous improvement initiatives.Project Management Experience: Demonstrated ability to work as a team member and to exercise independent decision-making. Continuous Improvement and Change Agent: Demonstrated ability to identify, initiate and manage change. 

Kedrion Biopharma offers a number of benefits to qualifying employees, including:

- Medical, vision and dental insurance

- Life and AD&D insurance

- Paid holidays

- PTO accrual

- and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have! 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.  For more information on E-verify, please contact the Dept. of Homeland Security.

Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.