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Specialist II, QA Operations

Company: Kite Pharma
Location: Gaithersburg
Posted on: January 16, 2021

Job Description:

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Kite Pharma Employees and Contractors:Please log onto your Internal Career Site to apply for this jobJob DescriptionWe are seeking a highly motivated individual to join us as a Specialist II, QA Operations at the clinical manufacturing site in Gaithersburg, MD. In this role, you will ensure quality product and timely delivery --- every patient, every time. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting into the Sr. Manager of Quality Assurance.Responsibilities (included but not limited to):Provide Quality Assurance support resolving raw material, in-process material and/or product, final product, environmental, analytical, facility and equipment manufacturing issues. Provide Quality Assurance input and oversight in resolving manufacturing and warehouse operations-related issues. Provide on-the-floor QA oversight in GMP cleanroom and laboratory environments and support to ensure compliance to GMP regulations throughout those areas. Perform quality walk-throughs and process observations. Disposition incoming materials. Perform receipt and disposition of incoming patient apheresis material. Perform issuance verification of production documents and labels, to meet production schedule. Review batch-related documentation, test methods and EM data and Disposition intermediate and final product.Ensure timely resolution and escalation of issues within the operational areas. Ensure products are manufactured in compliance with regulatory and GMP guidelines. Ensure all product-related Deviations are initiated, investigated and resolved. Ensure that associated CAPAs are initiated and resolved.Review and approve Change Control.Perform lot closure and disposition activities. Ensure approval and timely delivery of final product. Oversee the packaging and shipping process, and perform final product shipment authorization. Generate and revise standard operating procedures and associated documents. Identify compliance risks and escalate the issues to appropriate levels of management for resolution. Gather metric information for use in continuous improvement of areas of responsibility and report to management. Support audits - internal, client and corporate.May support Kite Urbana site in different QA capacities over time.Basic Qualifications:MA/MS degree in the biological sciences and 2 years--- experience in a pharmaceutical, biotechnology or biologics operation ORBA/BS degree in the biological sciences and 4 years--- experience in a pharmaceutical, biotechnology or biologics operation ORAA degree in the biological sciences and 5 years--- experience in a pharmaceutical, biotechnology or biologics operation ORHigh School diploma and 8 years--- experience in a pharmaceutical, biotechnology or biologics operationPreferred Qualifications:BA/BS degreeExperience in Viral Vectors, Cellular & Gene Therapy Products, blood and blood product or biologics.Works on multiple assignments in collaborative and dynamic environment.Working knowledge and ability to apply GMPs in conformance to U.S. 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.Strong knowledge with aseptic manufacturing processes.Proficient in MS Word, Excel, Power Point and other applications.Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.Experience with investigations, deviations, and CAPA, change control.Knowledge of validation principles.Strong interpersonal, verbal and written communication skills.Self-motivated, detail-oriented and comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.LI-ZN1Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow KitePharma on Twitter at .For jobs in the United States:As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careersgilead.com for assistance.For more information about equal employment opportunity protections, please view the ---EEO is the Law--- poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Kite Pharma Employees and Contractors:Please log onto your Internal Career Site to apply for this job. Full time

Keywords: Kite Pharma, Washington DC , Specialist II, QA Operations, Other , Gaithersburg, DC

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