Production Coordinator - Kedrion Biopharma : Job Details

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This range is provided by Kedrion Biopharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$24.00/hr - $29.00/hr

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Associate recruiter at Kedrion Biopharma

Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

The RhoGAM Fill/ Finish Production Coordinator 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.

The Coordinator will be responsible for the request of all required documentation from QA to perform production. In addition, thew coordinator will review and close out all documentation and deliver to QA in a timely manner for release.

The individual is expected to ensure all relevant documentation and reports involving the change are accurate, compliant, and timely, adhering to cGMP; environmental health and safety guidelines; and any other related regulations which could apply. In addition to making routine revisions to documents, The Production Coordinator may rewrite procedures or initiate new procedures as applicable. The person will work on the shop floor when needed to support production.

Main Responsibilities

· 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.

Education, Qualifications, and Experience

• 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.
• Good written and verbal communication skills.
• Team player and builder.
• Self-motivator.
• Good math skills and ability to perform calculations as per batch record.
• Computer literacy and proficiency with Microsoft Office and e-mail a plus.
• Sufficient technical competence to organize and lead production activities.
• Problem solving skills and results oriented.
• Ability to Multi-task Assignments.
• Ability to operate a computer using Microsoft.

Physical Requirements:

· Ability to stand/walk more than 75% of scheduled work time.

· Ability to handle chemicals with proper PPE (Respirator) for buffer solutions.

· Ability to work extended hours up to 17 hours if required.

· Ability to gown into coveralls or scrubs.

· Ability to work in a 2 to 8C° cold room for a minimum of 1+ hour.

· Ability to walk up and down stairs more than 5 feet high, more than 5x/day.

· Ability to clean rooms, equipment and parts during the shift.

· Ability to bend, stoop or kneel.

· Ability to lift, tug, push and pull up to fifty (50) pounds.

· Ability to wear required respirator.

Seniority level

• Seniority levelEntry level

Employment type

• Employment typeFull-time

Job function

• Job functionAdministrative and Quality Assurance
• IndustriesPharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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