• Job Description

  Req#: QUALI004163

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

  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.

  We are seeking a Quality Specialist III to join our Quality Ops department in Gaithersburg, MD. The qualified individual should have experience in and understanding of Quality operations industry business practices for Packaging Artwork and Labeling change management. The QA Specialist III will be responsible for support of GMP compliance with a focus on review of manufacturing records and lot release through provision of critical review, organization, and Quality oversight of records generated during GMP manufacturing of biotechnologically produced vaccines in a fully functional GMP manufacturing facility. The Specialist III will represent QA Operations on cross-functional teams and contribute to resolution issues.

  R esponsibilities include but are not limited to:

  • Review production batch records generated during the manufacture of vaccines for compliance to current Good Manufacturing Practices (cGMP) and Novavax Standard Operating Procedures (SOPs)
  • Provide on-the-floor QA oversight of manufacturing operations.
  • Review of deviation and excursion reports associated with manufacturing
  • Work with cross functional teams to resolve discrepancies and drive closure
  • Maintenance of systems for organizing, tracking, and reporting completed reviews and metrics.
  • Represent QA Operations in weekly planning meetings.
  • Review of logbooks generated during the manufacture of vaccines for compliance to current Good Manufacturing Practices (cGMP) and Novavax Standard Operating Procedures (SOPs).
  • Conduct final review prior to batch release approval
  • Track status of all Material Review Board (MRB) material and Interface daily with various departments
  • Interpret data and meet strict guidelines on documentation when recording data Identify compliance risks and works cross-functionally to identify and implement resolutions.
  • Author, review, and approve Standard Operating Procedures as it pertains to Raw Material Disposition and Material Specifications

  • Perform receipt inspection and critical reviews of Raw Material documentation submitted for QA disposition
  • Support and approve deviations and provide support of CAPAs and Change Controls as it pertains to the manufacturing operations, disposition of Materials and batch reviews, Track and trend raw material release data for Quality metrics

  • Respond to various interdepartmental requests. Answer questions and provide feedback to ensure Quality and departmental objectives are met
  • Review change controls and assesses for Quality Impact Works to continuously improve and streamline the raw materials release system.
  • Work with Quality system activities related to sampling, review and disposition of raw material and consumables.
  • Provide quality oversight of Raw Material Release activities and release
  • Have knowledge and understanding of industry business practices for artwork and labeling change management
  • Accountable to reach established goals or targets for moderately complex tasks with the involvement of immediate teammates without compromising commitments
  • Review and approve any artwork related change controls in accordance with artwork procedure
  • Reviews and approves internal artwork file in QMS

  Mi n im u m Requirements:

  • Bachelor’s degree in biological science or technical discipline.
  • 8+ years’ experience in GMP Biologics and/or vaccine manufacturing.
  • Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development to commercial application setting.
  • Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and Eudralex Vol 4), including regulatory inspection or support experience is preferred.
  • 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.
  • Strong communication and organizational skills

  Preferred Requirements :

  • Demonstrated ability to manage multiple priorities and maintain adherence to timelines
  • Demonstrated ability to lead and develop more junior employees
  • Demonstrated ability to manage process improvement projects
  • Demonstrated ability to identify and implement cross-functional improvements
  • Demonstrated ability to maintain relationships across the organization
  • Demonstrated knowledge of quality systems
  • Demonstrated ability to lead complex investigations with minimal supervision
  • The capability to apply understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
  • The capability to strategize the new direction of his/her work when change is encountered or necessary. Helps teammates with their own agility in a changing context
  • The capability to recognize inefficiencies in the team and identifies improvements constructively. Works across teams effectively. Frequently collaborates on larger items involving other areas. Contributes significantly to cross-functional work. Networks with senior internal and external peers in own area of expertise.
  • The capability to consistently develop networks that are diverse in level and function, identifies and initiates new relationships as well as creative alliances to accomplish business objectives, and inspires people with diverse needs to work together for mutual benefit

  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.

  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)

• About the company

  2267 Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland that develops vaccines to counter serious infectious diseases.

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