QA Analyst

Location: College Station, TX
Department: Azzur Austin, LLC

Job Description

We at Azzur Group are looking for a QA Analyst to immediately join our Azzur Consulting: Austin team. The QA Analyst is an FTE project based role.

Responsibilities:

  • Review basic and technical documentation to include, but not limited to:
    • Standard Operating Procedures
    • Batch Production Records
    • Commissioning, qualification and validation protocols and reports
    • Deviation Reports
    • Corrective Action/Preventive Action Plans
    • Data Reports
    • Drug Substance/Product Reports
  • Assist in and perform inspection of final product containers and review and/or approval of executed process records and data
  • Assist in and perform Quality audit functions to include, but not limited to:
    • Audit of lab notebooks
    • Audit of equipment logbooks
    • Review of vendor, supplier, contract laboratory audit questionnaires
  • Identify process and Quality System improvements
  • Notify Quality Analytical Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
  • All other duties as needed.

Required skills:

  • Excellent written and oral communication skills
  • Excellent organizational, analytical, data review and report writing skills
  • Ability to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly
  • Ability to work independently and establish work priorities to meet targets and timelines
  • Proficient in Microsoft Office
  • All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products

Qualifications:

  • Bachelor’s degree in a related science concentration with 2 years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
  • Bachelor’s degree in a related science concentration with 5 years of experience in Quality Control (chemistry, microbiology, etc) supporting pharmaceutical or biotechnology products; OR
  • Master’s degree in a related science concentration with 2 years of experience in Quality Assurance or Quality Control supporting pharmaceutical or biotechnology products;
  • Some exposure to good documentation practices, cGMP/GLP regulations.


Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM. 

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. 



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