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Specialist/Senior QA Manufacturing Operations Specialist-Viral Vector

King of Prussia, PA, US
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    Summary

    Center for Breakthrough Medicines is seeking a regulatory/quality expert to support the organization by establishing quality systems, drive growth, and ensure quality. The Senior QA Manufacturing Operation 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 quality manufacturing activities and operations including oversight of technical staff. The role also leads and manages site manufacturing operations, related programs, and activities to support the contract manufacturing organization and testing operations. The Sr. QA Manufacturing Operations Specialist supports Manufacturing 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.

    Responsibilities

    • 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 and guidance for deviations, technical documentation, program/process optimization projects, and audit readiness initiatives.
    • 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 manufacturing batches within assigned timelines to effectively deliver results to client
    • Ability to review data and effectively identify and trends or key issues
    • Lead all quality operations activities to drive execution and expedient delivery of program milestones
    • Ensure facility follows current GMP standards (cGMP)
    • Ensure quality and assists Quality Assurance in maintaining all technical regulatory requirements
    • Interacts and represents the Center for Breakthrough Medicines with all regulatory agency inspections and client audits
    • Support the development 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

    Qualifications

    • Bachelor’ s Degree in a commercial or scientific field required
    • Minimum 5-10 years’ experience in the Contract Research Organization (CRO), or biopharmaceutical industry within a GMP environment.
    • Possesses front-line practical experience and success in implementing quality systems
    • 5-10 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

    Physical Demands

    This position may require the ability to lift 25lbs

    This position may require the ability to stand for long periods of time.

Specialist/Senior QA Manufacturing Operations Specialist-Viral Vector

King of Prussia, PA, US
Apply Now >