Kedrion Biopharma

About Kedrion Biopharma

Exciting Opportunity to work in a brand new warehouse. Quality Associate is responsible to perform routine plasma documentation control activities. Quality Associate is responsible to check the documentation related to the acceptance and for the shipping of the Plasma intermediates. Check that the plasma and plasma intermediates documentation is in compliance with the GMPs, FDA, EU guidance and internal Standard Operating Procedures. Quality Associate is responsible to manage and trace all the Post Donation Information Report involving plasma storage at the NJ warehouse. Quality Associate reports directly to the Quality Warehouse Supervisor. Trace /manage all the incoming Post Donation Information and verify the status of the units implicated in the PDI. Main Responsibilities: Check the documentation of plasma and plasma intermediates in order to verify the compliance for the plasma fractionation processing. Check that the plasma and plasma intermediates documentation is in compliance with the GMPs, FDA, EU guidance and internal Standard Operating Procedures. Collaborate with the plasma supplier in order to solve any anomalies found during the documentation check. Trace of any units involved in a Post Donation Information Report in order to verify the status of the units and take the appropriate initiatives Perform internal audits Prepare SOPs, handle deviations and investigations, participate in change control activities. Knowledge, Skills, and Abilities Focus on delivering excellent customer service. GMP and strong quality culture-oriented individual. Good communication skills both verbal and written. Problem solving skills, results oriented. Experience with pharmaceutical investigations. Knowledge of Microsoft Office and e-mail required. Qualifications: HS Diploma or equivalent – Associates Preferred At least 3 years of pharmaceutical experience in Quality or Operations department. Experience with biologics Quality Assurance or Operations plus. Plasma fractionation experience plus. Ability to travel to Melville, NY for training All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Job Type: Full-time Salary: $18.00 to $22.00 /hour Pay may depend on skills and/or qualifications Experience: Quality: 1 year (Preferred) Education: High school or equivalent (Required) Work Location: One location

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Legal Form: GmbH

Company Size: 1001 - 5000

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