QA Specialist - I
ATR International - El Segundo, CA
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We are seeking a QA Specialist - I for a very important client.Responsibilities (included but not limited to):- Perform receipt and disposition of incoming apheresis material.- Perform verification/inspection and ensure timely issuance of production documents and labels- Perform shipment authorization- Perform incoming label inspection- Review batch-related documentation, and ensure resolution of issues to release and ship product.- Ensure timely resolution and escalation of issues in operations- Ensure all product-related Deviations are initiated, investigated and resolved.- Ensure that associated CAPAs are initiated and resolved, as needed.- Ensure approval and timely delivery of final product.- Ensure products are manufactured in compliance with regulatory and GMP guidelines.- Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.- Gather metric information for use in continuous improvement of areas of responsibility.- Maintain/Update huddle board tracker, deviation tracking log, task tracker and issue monthly reports. Requirement: The ideal candidate will posses the following qualifications:Preferred Qualifications:- Works on multiple assignments in collaborative and dynamic environment.- Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards- Ability to effectively negotiate and build collaboration amongst individuals- Strong teamwork and collaborative skills- Experience with manufacturing investigations, deviations, and CAPA.- Experience with change control practices and strategies.- General knowledge of aseptic manufacturing processes.- Proficient in MS Word, Excel, Power Point and other applications.- Strong interpersonal, verbal and written communication skills- Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
Created: 2024-09-07