Job Summary Bring your leadership to the heart of life-saving manufacturing.

At Kedrion Biopharma, every step of our manufacturing process contributes to therapies that improve and save lives for people with rare and serious conditions. As a Production Coordinator, you will be responsible for the compliant execution of SAP transactions, order production components, materials, and assist with investigations /deviations related to RhoGAM fill finish department inclusive of Filling, Syringe inspections and Packaging. The coordinator will be required to support the production floor operation as needed. This is more than just production its about precision, compliance, and the knowledge that your work impacts patients worldwide.

What you'll do What Youll Do:

Your responsibilities will include extensive environmental monitoring (EM) and meticulous documentation for the following:

Key Responsibilities include:

Perform all tasks required of a RhoGAM Fill/ Finish Operator. Perform all process order transactions in SAP for RhoGAM filling, Manual syringe inspection, and Packaging. Perform all logbook, batch record and other department related document reviews and close out upon the completion of all production batches and deliver the documentation to QA in a timely manner for review. Request all logbooks, batch record and other department related documents from QA in a timely manner. Assist with investigations /deviations related to RhoGAM fill finish department inclusive of Filling, Syringe inspections, Packaging and Hemin production. Participate in the creation, review and revision of Standard Operating Procedures and other manufacturing-related documents related to the department. Ensure compliance with all regulations that impact the manufacturing operations. Assure adequate inventory of production and cleaning supplies are maintained daily by monitoring and managing proper levels of inventory through SAP. Adhere to safety/EHS requirements, SOPs, cGMP, work rules and other company policies. May be responsible for the delivery of final container samples to the respective laboratories. May perform other duties as assigned. Qualifications and need-to-know Qualifications:

High School Diploma or GED. College degree preferred in Biology or related. Knowledgeable in SAP and TrackWise and Master ControlControl Systems preferred. Must be flexible, able to work extended hours (overtime), and alongside multiple departments. Prior experience with aseptic techniques is preferred. Experience in a Quality Control or cGMP environment is a plus. Strong written and verbal communication skills. Excellent organizational skills and proficiency with Microsoft Office Suite. Pay Range: $26.00-$29.00

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including:

Medical, vision and dental insurance Life and AD&D insurance Paid holidays PTO accrual and much more!

Kedrion Biopharma

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