Specialist I, QA/Batch Release Project Coordinator
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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 Specialist I to join our Quality Assurance as batch release and project coordinator in Gaithersburg, MD. The specialist will be responsible for support of GMP compliance with a focus on project coordination between the various QA/QC groups. The candidate will provide project coordination support, ensure organizational alignment of the QA/QC teams, and ensure all documents and the data is accurate, provide status update on all on going projects and programs. This position will require periodic weekend/evening work and travel.
**Must be flexible and open to travel**
Responsibilities include but are not limited to:
- Review of project and program status, provide support to the entire QA/QC organization as needed. Work closely with the Director of batch release project manager to ensure that all project are on time or communicate appropriately.
- Track all batch release and other project status to ensure success.
- Be aware of all quality system issues that can derail batch disposition
- Implement robust project coordination and management tools to track progress.
- Maintain department metrics
- Proactively track batch records and disposition based on expected turnaround times.
- Facilitate continuous improvement projects as directed
- Learn all electronic systems to provide efficient updates
- Attend team meetings and interdepartmental meetings
- Ensure compliance by maintaining training completion on time
- Other duties as assigned
- No experience with BS or up to 2 years equivalent to GxP industry experience
- Basic understanding of project coordination
- Strong communication and organizational skills
- Basic understanding of project management and good computer skills
- The established recognition within the quality organization as good project coordinator
- Demonstrated ability to work well with computer programs
- The ability to represent the team cross-functionally; to apply an understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas
- The ability to produce high-quality work with cross-functional involvement; to anticipate and proactively communicate project delays
- The capability to consistently develop networks that are diverse in level and function, identify and initiate new relationships as well as creative alliances to accomplish business objectives, and inspire people with diverse needs to work together for mutual benefit
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)