Quality Assurance Compliance Specialist III
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Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
Summary of the Position:
We are seeking a Quality Assurance Compliance Specialist III to join our Quality department in Gaithersburg, MD. The Specialist III will primarily be responsible for quality oversight and review of data supporting product development and GMP activities. The Specialist will be working closely with Quality Control, CMO and manufacturing organizations for review and approval of including but not limited to protocols and summary reports, deviations, out of specification (OOS) investigations, CAPAs and change controls to meet business goals in a compliant manner.
This position reports directly to the Director of Laboratory Compliance.
Responsibilities include but are not limited to:
- Provide Quality technical support to the internal Novavax QC organization as well as cross-functional Novavax teams working through data reviews for product development, technology transfer, stability, and/ or GMP testing activities both internally and at our contract manufacturing, testing sites, and Alliance partners.
- Support the quality impact assessments/risk assessments for deviations, OOS investigations, and change controls related to manufacturing and testing activities and provide the required quality assessment and approval for these quality records.
- Support Novavax technical teams by providing QA input, review, and approval to study designs, protocols, technical reports, and new program implementations.
- Support Quality Control 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
- Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 8+ years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.
- Understanding of Quality Assurance systems
- The ability to organize, prioritize and deliver tasks & projects with a sense of urgency
- Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax
- Capable to manage multiple priorities, adapt and maintain adherence to timelines
- Demonstrated technical knowledge
- Demonstrated ability to manage process improvement projects
- Demonstrated knowledge of GMP, GLP, GCP and GCLP expectations
- The ability to keep colleagues and management apprised of projects and status independently and appropriately; to anticipate future needs based on prior experiences.
- The accountability to reach established goals or targets for moderately complex tasks with the involvement of immediate teammates without compromising commitments
- The capability to assist other team members in a small number of areas and learns additional knowledge cooperatively; to build influence by completing tasks and presenting new ideas; to contribute to cross-functional work; to build relationships internally and coordinates work with others
This position may require periodic weekend/evening work.
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.
Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Gaithersburg, Maryland, USA
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