Associate, Quality Operations

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. PURPOSE Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams. ESSENTIAL JOB FUNCTIONS / DUTIES Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements. Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures. Develop and optimize SOPs and other controlled documents for the Quality Assurance department. Review and approve SOPs and other controlled documents for the functional areas as the Quality representative. Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications. Review, assess, and release quality control tests and Certificates of Analysis Review and approve executed batch records. Provide guidance and support to departments on errors to ensure error reduction. Assist in the final disposition of master cell banks and viral vector products. Review and approve qualification/validation protocols and reports and technology transfer reports. Provides site GMP and GDP training (annually, for new-hires, and as needed). Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events. Working cross-functionally with all departments to ensure Quality Events are thorough and accurate. Drive Quality Events to closure within on-time closure deadlines. Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products, Review and approve Master Batch Records. Review and approve Media Fill Protocols and Reports, as well as participate as a Quality observer as needed. Review and approve Stability Protocols. Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas Initiate, review, approve and monitor Change Management activities Work with the other functional areas to give guidance on use of quality systems. Assist the Lead Auditors to perform site internal audits. Lead and/or support customer audits and regulatory inspections by participating in either front or back room. Collaborate cross-functionally (e.g., Operations, Manufacturin…