At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.
We are seeking a Quality Systems (QS) Specialist III to join our Quality Systems Department. The QS Specialist III will receive general guidance on work and interact with supervisor regularly, but be able to operate independently within Quality Systems. The Specialist will be responsible for general support and maintenance of the Quality System within the requirements of FDA Quality System Regulation (QSR). The primary duties for this individual will be to review and approve laboratory investigations, deviations and CAPA and manage the Change Control program. Additional functions include writing and revising standard operating procedures, training, and tracking and trending data. Duties for this position support Manufacturing, Quality Control, Quality Assurance, product release, and training.
Responsibilities include but are not limited to:
- Create, monitor, review and approve Laboratory Investigations, Deviations and CAPA
- Track and trend Quality System Data
- Perform Root Cause Analysis
- Facilitate management of Change Control Program
- Review of change requests for content and completeness
- Generate and update standard operating procedures to define and improve quality system functions
- Revise existing documentation and processes to support continuous improvement
- Participate in the implementation and delivery of the Quality Management System training program
- Interface with other departments regarding documentation requirements and complex investigations.
- Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes.
- Handles non-routine situations for review and approval by senior staff
- Bachelor's Degree in a relevant life science field such as Biology, Microbiology, Chemistry, Biochemistry, etc. with at least 5 years of working experience in Quality Assurance, Quality Control or Manufacturing
- Previous professional experience with cGMPs and associated regulatory compliance requirements and guidelines for the manufacture, testing, and release of pharmaceutical or biopharmaceutical products
- Knowledge of FDA requirements including 21CFR210, 211 and Quality System Regulations
- Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met
- Experience in compiling data to support metrics analyzing current processes
- Proficiency with Microsoft Word, Excel and Power Point
Additionally, we prefer candidates that have:
- The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems
- The ability to support teams and meetings and represent Quality Assurance at cross-functional meetings
- The ability to exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action
- The ability to correlate events and determine the action plan required to avoid incidents recurrence and/or regulatory exposure
- The ability to organize, prioritize and deliver tasks and projects with a sense of urgency under minimal supervision with neglecting attention to detail
- The ability to enable and drive change while being focused on internal and external customers
- The ability to communicate well both verbally and in writing with all levels both inside and outside of the organization
- Prior experience with Lean Six Sigma and/or Operational Excellence programs
- The capability to manage multiple priorities
- This position may require periodic weekend/evening work
Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.
Novavax, Inc. offers a base salary, annual bonus, stock options, 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, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.