Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
The QC Systems Specialist will be working as part of Quality Control (QC) team. This role reports to the QC Systems Manager.
Responsibilities include but are not limited to:
Ensure that deadlines are maintained and closely monitor the need for extensions to be administered in order to maintain compliance
Independently responsible for the efficient and thorough investigation of quality control deviations, determination of root cause, and initiation of meaningful corrective/preventative actions designed to adequately address and correct the deficiencies identified during the investigation process; As part of each investigation, gather information from all necessary sources in order to evaluate the impact of the deviation, as well as risks
Perform trending review of deviations and investigations, compile report and identify trends or areas requiring additional actions
Conduct analysis and periodic reviews of written procedures and submit procedural revisions as required
Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards
Work independently and carry out tasks with general instruction
Other duties as assigned
BA, BS or MS in Biology, Biochemistry, Pharmaceutical Science or related discipline
Five plus years of related biopharmaceutical laboratory experience in regulated environment
Experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Control function with a strong familiarity with Good Manufacturing Practices (GMPs) and 21 CFR
Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
Experienced in writing and reviewing technical documents
Possess excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines
Possess excellent customer service skills and have strong verbal and written communication skills
Ability to work in dynamic fast paced team environment
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in 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.