Quality Assurance Specialist

2 weeks ago


San Diego, United States Thrive Full time

A Pharmaceutical client is looking for a Senior Quality Assurance Specialist , specifically with documentation experience in biotechnology or pharmaceutical industry


Job Overview


Senior QA Documentation Specialist, you will be instrumental in the management and evolution of the Veeva Learning Management System to meet the challenges of compliance in late-stage clinical drug product and commercial drug product. The Senior QA Documentation Specialist will be responsible for supporting the daily activities of Documentation Management.


Job Functions: (Primary essential duties and responsibilities)

  • Developing, continuously improving, and implementing procedures related to Documentation Management.
  • Assisting functional area management in driving timely completion of periodic reviews.
  • Maintaining the Record Retention Schedule for GxP documents/records
  • Filing/Archiving GxP documents/records as required
  • Providing day-to-day support of electronic document management system (Veeva Quality Vault: Quality Docs)



Required Knowledge, Skills and Abilities:


· Experience with Veeva Quality Vault: QualityDocs

· Strong working knowledge of cGxPs and international regulatory requirements



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