QA Analyst

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

Job Description

We at Azzur Group are looking for an experienced QA Analyst to join our Azzur Consulting: Austin team. 

Essential Functions:

  • 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.

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 2 years of experience in Quality Control (chemistry, microbiology, etc) supporting pharmaceutical or biotechnology products; OR
  • Master’s degree in a related science concentration with 1 years of experience in Quality Assurance or Quality Control supporting pharmaceutical or biotechnology products;
  • Some exposure to good documentation practices, cGMP/GLP regulations.
  • All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products


Apply Now

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