Center for Breakthrough Medicines is seeking a regulatory/quality expert to support the organization by establishing quality systems, drive growth, and ensure quality. The QA Testing Specialist will help build scalable QA systems as the organization continues to grow. The role will be responsible for the overall management of the quality system within the organization and oversees all testing laboratory activities and operations including oversight of technical staff. The role also leads and manages site testing operations, related programs, and activities to support the contract manufacturing organization and manufacturing operations. The QA Testing Specialist supports Testing Operations, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. It also ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.
Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs Provide Quality input for the investigation of OOS results including support on determining investigative testing plans, resampling, and root cause analysis Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities Approval of Certificate of Analysis for release of testing results within assigned timelines to effectively deliver results to client Ability to review data and effectively identify and trends or key issues Direct all laboratory activities to drive execution and expedient delivery of all testing Ensure facility follows current ISO and GMP standards (cGMP) Ensure quality and assists Quality Assurance in maintaining all technical regulatory requirements Interacts and represents The Discovery Labs with all regulatory agencies Develop quality systems including a robust and on-going quality improvement system compliant with GMP Maintain knowledge of global regulatory requirements Responsible for authoring quality lifecycle management documents of facilities, processes and equipment and using appropriate quality systems for implementation and maintenance Develop and maintain systems that insure the technical and regulatory competency of personnel within the organization Oversee all aspects of QA testing operations within the organization, including but not limited to batch record review, QA support on floor, material release, deviation investigations, CAPAs, change controls, customer quality support, SOPs. Review master batch records, product labels and all product specific documents Interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of viral vector products as needed Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs Foster a Quality mindset throughout the company by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions Manage problems of varied scope using a high degree of prudence and risk-based decision making Monitor, study performance via key performance indicators to maintain or improve operational efficiencies, while ensuring compliance to GMP regulations Ensure test methodologies provide quality of results required and are in full compliance with regulatory requirements, standards, and protocols Prepare reports and keep upper-level management informed of progress Additional duties as assigned
Bachelor' s Degree in a commercial or scientific field required 2+ years’ experience in the Contract Research Organization (CRO), or biopharmaceutical industry within a GLP or GMP environment. CRO and both GLP & GMP experience is preferred Possesses front-line practical experience and success in implementing quality systems 2 years Quality Professional in Pharmaceutical and Biological Manufacturing Proficient in Verbal and Written communication skills Proficient in Microsoft Office (Excel, Word, Outlook) Excellent problem solving, risk analysis and negotiation skills Ability to review data and effectively identify and trends or key issues Ability to manage multiple projects simultaneously ensuring on time execution of deliverables