Technical Writer (QA)
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 an QA Tech Writer to join our growing South San Francisco team!
The QA Technical Writer reviews and edits cGMP documents, which include but not limited to procedures, records, protocols, and reports. The Tech Writer provides support and collaborates cross-functionally within the organizations and helps create successful product campaigns by producing error-free documentation. The Tech Writer also supports document control processes and systems for GxP activities in compliance with internal procedures and policies, as well as regulatory requirements.
- Review and edit cGMP documents to ensure the document is accurate and clear with explicit description and justifications.
- Develop new cGMP and technical documents and follows established practices and/or procedures.
- Manage document review schedules and ensure all review comments are addressed and meet the industry standards and regulatory requirements.
- Drive the improvements on cGMP documentation practice to improve efficiency.
- Update management on activities as well as provide input and recommendations as appropriate.
- Bachelor’s degree in science-related discipline.
- 2-5 years of technical writing experience.
- Technical writing experience in biotech or pharmaceutical industry preferred.
- Experience with both paper based and electronic Document Management Systems (DMS).
- Strong technical writing skill with advanced proofreading and editing skills.
- Good knowledge of cGMP terminology and environment.
- Demonstrated ability to work and communicate collaboratively with other independent workers and to train workers in new procedures, as necessary.
- Must have strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills.
- Ability to communicate clearly and precisely, both orally and in writing, is essential.
- Highly motivated, able to multi-task, strict attention to detail and open to be responsible for successful execution of tasks.
- Must be able to work onsite in South San Francisco 50% of the time.
Vaxart offers team members a competitive compensation and benefits package, including a bonus program, stock options, 401K 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.