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.

Quality Warehouse Associate is responsible to perform routine plasma documentation and other plasma inbound activities to assure the compliance with the GMPs, FDA, EU guidance and internal Standard Operating Procedures.

Quality Warehouse Associate is responsible to manage and trace all the Post Donation Information Report involving plasma stored at the NJ warehouse or transferred to Melville Plant. 

Quality Warehouse Associate is responsible for the inspection, sampling and disposition of printed packaging components, incoming materials, as well as performing general inspection duties. Quality Warehouse Associate will uphold the safety regulations of our company and make sure that all product and/or incoming materials meet quality expectations, according to material specifications. Quality Warehouse Associate is responsible to check the documentation related to the acceptance and for the shipping of the Plasma and Intermediates..

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.Perform the plasma inbound dock task per SOP.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 initiativesPrepare SOPs, participate in change control and in deviations / investigations activities.Monitor, perform and document sampling and inspection of raw material/components and document the results in compliance with cGMP and company procedures Sampling or physical inspection of raw materials and componentsInspection and release of final product labels by verifying accuracy and completeness against a standardMonitor and audit warehouse areas to ensure quality and compliance with all SOPs, cGMP, company policies as well as FDA, EU, and other regulationsReject incoming materials that fail to meet quality expectationsMeasure product dimensions examine functionality and evaluate the materials to their specifications.  Maintain documented evidence of work productSupports GMP record reviews

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.  

Requirements:

HS Diploma or equivalent – Associates PreferredAt least 3 years of pharmaceutical experience in Quality or Operations department plus.Experience with biologics Quality Assurance or Operations plus.Plasma fractionation experience plus. Ability to travel to Melville, NY for trainingMust be organized and able to work as a team Strong verbal and written communication skills are requiredLifting up to 40 lbs. required

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! 

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.