Sr. QA Associate

Location
South San Francisco, CA
Posted
Apr 02, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

About Us:

Vaxart is a clinical-stage company developing tablet vaccines based on its proprietary oral vaccine platform. The lead programs are prophylactic oral vaccines for COVID, seasonal influenza, RSV, and norovirus, as well as a therapeutic vaccine for HPV types 16 and 18. Vaxart vaccines are convenient room temperature-stable tablets that are easy to administer, and that eliminates the risk of needle-stick injury and medical waste associated with injectable vaccines. Vaxart is listed on the NASDAQ exchange under ticker symbol VXRT.

Summary:

The Quality Assurance Associate is responsible for quality systems, compliance, and oversight of manufacturing operations. Principle responsibilities are quality oversight of manufacturing activities at CMO, 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.

Responsibilities:

  • Manufacturing Support may include, but is not limited to, the following:
    • Oversight and Support of both internal and external CMO GMP Manufacturing Activities.
    • Perform disposition of clinical API, API intermediates, final drug product, starting materials, and raw materials in support of Manufacturing operations.
    • Review production batch and test records and associated data for product disposition. Determines if records are within range of cGMP regulations. Reviews data obtained for compliance specifications and report abnormalities.
    • Use risk management tools to identify and assess quality related risk with recommending resolutions and implementing risk mitigation measures as needed.
  • Quality Support
    • Participate in building and improving quality systems.
    • Control and execution of Deviations.
    • Corrective/Preventive Action (CAPA) plans.
    • Out-of-Specification/Out-of-Trend (OOS/OOT) results.
    • Nonconforming materials.
    • Environmental monitoring excursions.
  • Compliance support may include, but is not limited to, the following:
    • Internal and external audits.
    • Preparation and support for internal audits.
  • 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:

  • B.S. in Biological Sciences, Pharmaceutics, Engineering or closely related field and 8 years’ experience of Quality Assurance experience in the biopharmaceutical/vaccine industry or an M.S. with 5 years’ experience.
  • Comprehensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization.
  • Knowledge and understanding of implementing phase appropriate procedures and processes. Able to make appropriate risk-based assessments and decision based on phase-specific requirements for early to late-stage clinical phase CMC manufacturing.
  • 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. The 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.
  • Experience in biotechnology industry is highly preferred.
  • Ability to safely lift at least 25 pounds.


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.