Quality Assurance Specialist Ii, Validation

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

Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. 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.

Novavax is looking to fill a QA Validation Specialist I/II position. This position will support qualification of manufacturing and lab equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. This position will require the individual to work on site with the option to work remotely when not actively executing protocols. 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 head of QA Validation.

Responsibilities include but are not limited to:

Support Facility, Equipment, Shipping, and Process Validation with the following:

• Interface with system owners, IT, and facilities engineering to ensure all user and compliance requirements are tested.
• Follow Good Documentation Practices to ensure data integrity.
• Review, edit, approve deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports, and other documentation.
• Evaluate vendor qualification packages and create Novavax wrappers.
• Perform Data Integrity and Quality Risk Assessments for new and existing systems
• Other duties may be assigned as needed.
• 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.
• Generate and execute Commissioning, Qualification, and Validation protocols, summary reports, SOPs, and specifications 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 integrity.

Minimum requirements:

• Experience working on cross-functional teams.
• 0-5 years of experience in Pharma or/and Biotech environment
• Continuously seek to improve processes for improved performance.
• Team player.
• Familiar with Data Integrity and Risk Assessment
• Excellent verbal and written communication skills.
• Computerized System Validation is valuable, but not preferred for this position
• Can coordinate with other departments or outside contractors/vendors to complete validation tasks.
• At least 2 years of experience with any of the following: Facility, Laboratory or Manufacturing Equipment, Cleaning, and/or Process Validation
• Comfortable with uncertainty and high expectations.
• Bachelor’s degree in Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline
• Proven ability to run multiple tasks concurrently under aggressive timelines in a dynamic environment.

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)