Novavax
  • 24-May-2021 to 23-Jun-2021 (EST)
  • Quality Assurance
  • Gaithersburg, MD, USA
  • Full Time - Exempt

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.  Novavax is 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. Novavax is 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 looking to fill a QA Validation Specialist II/III position. This position will validate and qualify filling equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. Also, this position requires a highly motivated individual who can work effectively in a dynamic environment with a high degree of flexibility and creative problem-solving approach.

This person will report to the Manager QA Validation.

Responsibilities include but are not limited to:

Support shipping, facility, equipment, and process validation department by:

  • Author and execute qualification protocols for new system implementations or changes to existing systems.
    • Interface with system owners, IT, and facilities engineering to ensure all user and compliance requirements are tested.
    • Evaluate vendor qualification packages and create Novavax wrappers.
    • Follow Good Documentation Practices to ensure data and record integrity.
  • Author final reports.
  • Generate, execute, and/or review master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
  • Analyze the results of testing and decide the acceptability of results against pre-determined criteria.
  • Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
  • Review, edit, approve deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports, and other documentation.
  • Perform Data Integrity and Quality Risk Assessments for new and existing systems
  • Other duties may be assigned as needed.

Minimum requirements:

Bachelor's degree in Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline

  • 3-5 years of experience in Pharma or/and Biotech environment
  • 3+ years of experience with any of the following: Process Equipment, Laboratory Equipment, Cleaning, and/or Process Validation
  • Familiar with Data Integrity and Risk Assessment
  • Can coordinate with other departments or outside contractors/vendors to complete validation tasks.
  • Continuously seek to improve processes for improved performance.
  • Team player.
  • Excellent verbal and written communication skills.
  • Experience working on cross-functional teams.
  • Proven ability to run multiple tasks concurrently under aggressive timelines in a dynamic environment.
  • Comfortable with uncertainty and high expectations.

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.

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