QC Associate

Location
South San Francisco, CA
Posted
May 22, 2021
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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 and eliminate the risk of needle-stick injury.

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 QC Associate to join our growing South San Francisco team!

* Please note that we cannot sponsor Visas at this time.

Summary:

The QC Associate is responsible for performing GMP testing to support product lot release and in-process testing. Additionally, this role will provide technical support and troubleshooting for cell-based potency testing.

Responsibilities:

  • Perform GMP lot release and in-process testing for cell-based test methods and perform data analysis using various software packages.
  • Support assay transfer and method validation of by executing cross-site validation protocols and providing data to support final reports.
  • Assist in the implementation of new assay methodologies and the associated instrumentation.
  • Generate weekly, monthly, and annual metrics and reports.
  • Support QC Equipment IQ, OQ, PQ, PM, and Calibration activities.
  • Review and Approve Discrepancies and CAPAs
  • Perform cell banking and cell line maintenance activities.
  • Participate in cross-functional assay training.
  • Author test methods and SOPs.

Requirements

  • BS in a scientific discipline with 3+ years of regulated industrial analytical testing or QC experience, or equivalent combination of education and experience
  • Sound understanding and knowledge of cell-based potency assays as performed in a commercial GMP QC laboratory. Experience with SoftMax and Gen5 data analysis software is a plus.
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
  • Computer proficiency as well as strong scientific and organizational skills.
  • Ability to maintain flexible intellect and adjust to a dynamic work environment.
  • Experience working in a regulated (GxP) environment and able to participate in Quality Systems.
  • Demonstrated success working in a high-performing, business results-driven environment.

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.