ABOUT US:
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.
Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication.
Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.
We are looking for a QA Associate to join our growing South San Francisco team!
SUMMARY:
The QA Associate (QA Associate I/II) of QA Operations is to provide quality oversight of clinical product manufactured in Vaxart facilities, and at contract service provider. The position supports the establishment and maintenance of biologics clinical vaccination program related to the product development, product manufacturing, product testing, and material disposition. Principle responsibilities are quality oversight of manufacturing and quality control activities in Vaxart facilities, and at contract service providers; review of batch records; quality systems support; and compliance support. Quality systems support may include, but is not limited to, ensuring the proper documentation, investigation, impact and risk assessments, corrective / preventive action plans, monitoring and trending. Support document control processes and systems for GxP activities in compliance with internal procedures and policies as well as regulatory requirements. The successful candidate will interact successfully across multiple disciplines and at all levels of the organization and vendors.
RESPONSIBILITIES:
Manufacturing Support may include, but is not limited to, the following:
Quality Support:
Compliance support may include, but is not limited to, the following:
Ability to problem solve, think critically, and troubleshoot while working independently.
Participate, observe, and/or monitor day to day quality operations.
Ensure accurate and timely resolution of quality related activities.
Communicate issues and assess their impacts and collaborate with others to resolve/mitigate those issues.
Update management on activities as well as provide input and recommendations as appropriate.
REQUIREMENTS:
Vaxart offers team members a competitive compensation and benefits package, including a bonus program, stock options, 401(k) with employer matching, tuition assistance, and work life balance.
Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include: recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.