Manufacturing Documents Coordinator

2 days ago


San Carlos, California, United States BioSpace, Inc. Full time
Job Overview:

Vaxcyte is hiring a skilled Manufacturing Documents Coordinator to manage the day-to-day activities related to manufacturing documents in a GXP compliant environment. This role requires strong organizational skills and attention to detail to maintain quality management system processes, document control, and change management.

The ideal candidate will have:
  • Maintained quality systems documentation in Veeva and other electronic systems
  • Performed document specialist functions in QA, including creation, revision, approval, distribution, and archival
  • Collaborated with quality assurance, vendors, functional areas, and project management team for daily management of routing, revisions, approval, and filing of documents
  • Ensured accurate and reliable filing systems for electronic and paper-based GMP documents
  • Supported audits as appropriate

Requirements:
  • Bachelor's degree or equivalent experience
  • 2+ years of biopharmaceutical industry experience
  • Experience with managing quality management system processes, document control, and change management
  • Experience with Veeva QualityDocs preferred
  • Familiarity with GxP manufacturing and testing activities, and current regulatory expectations
  • Demonstrated ability to collaborate and influence, strong interpersonal and communication skills
  • Strong attention to detail, organizational skills, and ability to work in a fast-paced environment

Key Skills:
  • SmartSheet, Microsoft Office Suite, Word, Excel, PowerPoint, Visio, and Adobe

Reports to: Director, Quality Assurance, Drug Product

Location: San Carlos, CA

Estimated Salary: $121,000 - $131,000 per year

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