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Review and approval of batch related documentation (Solution Lot records, Reports, Logbooks and Release of Autoclaved Equipment) to support product disposition. Transport batch related documentation across RTP buildings to support chain of custody and life cycle management.
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Control changes, reviews, approvals, disposition and retention of all BPS documentation using QMS software application. LOCATION: Washington, DC – Hybrid, two days a week in the office (Tuesday & Thursday.
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You work in collaboration with the Operations team by gathering field measurements, notes/plans, photo documentation, and materials necessary while using your understanding of restoration and the true costs of construction to create accurate estimates and preliminary budgets.
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Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with Client policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.
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Iovance is seeking a highly motivated individual for the position of GMP Quality Assurance Associate, Documentation at Iovance's IOVA facility (700 Spring Garden St) located within American Red Cross in Philadelphia, PA. This position is responsible for the Quality Assurance documentation related activities in support of the manufacturing/testing operations and ensuring compliance to quality objectives and regulatory requirements.
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Performs the compliance review and approval of all manufacturing batch documentation related to disposition of products. The technical writing aspect will utilize knowledge, experience and understanding of documentation best practices to produce high-quality technical documentation including deviation and investigation reports, SOP’s, and other supporting documentation.
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Reviews documentation to verify and, when necessary, correct the patient disposition upon discharge, as well as the admit type and admit source. Review appropriate provider documentation to determine principal diagnosis, co-morbidities and complications, secondary conditions, and surgical procedures.
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Assist with the HFI process to include documentation, production accounting, disposition, rework activities, AQL or sampling. Maintain and develop quality function documentation such as forms, instructions, and training guides, as well as, the records for BRCGS and ISO compliance in accordance with record retention policies & requirements.
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Provide detailed engineering analysis and documentation in the management of material disposition, process updates, Client's and CAPA. Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities.
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The Senior QA Associate, Batch Release, is responsible for the management and direct oversight of processes related to the review, reconciliation and documentation of records supporting the compliance and disposition of product manufactured at Abzena's Bristol (PA) facility.
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Jobs designated as a Health Care Personnel (HCP) position, requires that you have documentation that you have completed the following immunizations prior to your first day of employment: MMR (Measles, Mumps and Rubella, Varicella (Chicken Pox), Hepatitis B, Influenza, and T-dap (Tetanus - Diphtheria - Pertussis), and COVID-19 is required.
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Duties may include psychosocial assessment; care coordination, consultation to the team, individual, family or group psychotherapeutic treatment; liaison with community agencies; treatment plan documentation; and disposition planning and advocacy.
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Discover Impactful Work: The Quality Assurance Batch Disposition Technician will be responsible for the execution of QA review and disposition of executed production batch records. Serve as QA approver/author for SOP revisions, quality investigations, and other required site documentation.
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Consult with the Records Manager to address disposition procedures, by document type and location (NIPR/SIPR), as well as, determine the appropriate action required for proper disposition.
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Responsibilities of this position include, but are not limited to, Quality Operations review and approval of materials, bill of materials, batch records and GMP documentation to support the design, implementation, and maintenance of manufacturing processes that meets or exceed FDA requirements.
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