Quality Operations Quality Engineer

    Updated 30+ days ago
    Gaithersburg, MD 20877
    Full-time, Part-time
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    Job Description

    Job Description

    If you find science, speed, and success exhilarating, you have come to the right place.

    Novavax, Inc.(Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavaxis currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.Novavaxis a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

    We are seeking a Quality Operations Quality Engineer to join our Quality Assurance department in Gaithersburg, MD. The Quality Operations Quality Engineer will be responsible for Quality technical support and risk/impact assessments for Deviation/CAPA/OOS execution and Change Management execution within the Quality Operations Department. The position will be located at our Gaithersburg, MD facility and will report to the Quality Engineering Lead.

    Responsibilities include but are not limited to:

    • Provide Quality technical support to the internal Novavax QA Ops organization as well as cross-functional Novavax teams working through issues or continuous improvement activities both internally and at our contract manufacturing and testing partners.
    • Support the quality impact assessments/risk assessments for Deviations, Out of Specification Notices and Change Control notices related to outsourced manufacturing and testing activities and provide the required Quality assessment and approval for the quality records.
    • Support Novavax technical teams by providing QA input, review, and approval to study designs, protocols, and technical reports.
    • Support Quality Operations during regulatory inspections and in maintenance of a state of inspection readiness.
    • Maintain working knowledge of Novavax Documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
    • Stays current and is an internal Novavax subject matter expert for changes in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
    • Effectively collaborates with departments across the company to analyze and resolve technical issues in accordance with appropriate quality standards.

    Minimum requirements:

    • Bachelor's Degree in Biology, Chemistry, Engineering, or related field with 8+ years' experience in the Pharmaceutical/Biotech industry with 5+ years supervisory experience.
    • Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, including technology transfer and PPQ.
    • Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and Eudralex Vol 4), including experience hosting regulatory inspections.
    • Excellent multi-tasking, analytical, organizational and leadership skills.
    • Ability to troubleshoot, identify root cause and systematically resolve problems.
    • Ability to communicate clearly and effectively with all levels of the organization.
    • Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.

    Additionally, we prefer candidates that have:

    • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
    • The ability to enable and drive change while being focused on internal and external customers.
    • Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax.
    • Capable to manage multiple priorities and maintain adherence to timelines.

    Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

    Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

    Equal Opportunity Employer/Veterans/Disabled

    Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

    Job Posted by ApplicantPro
    Posting ID: 612883258Posted: 2021-03-21Job Title: Quality Engineer