GMP Document Control Specialist — Pharma/Biologics

Planet Pharma

Newark (CA)

On-site

USD 55,000 - 69,000

Full time

5 days ago
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Job summary

Planet Pharma in Newark, CA seeks a detail-oriented Document Control Specialist to support controlled-document lifecycles across production, testing, validation, and quality operations within a GMP environment. You will collaborate with cross-functional partners, maintain templates, and ensure timely, accurate documentation.

The role emphasizes strong organizational skills, proficiency with Word/Excel/Acrobat/Visio, and experience with electronic document management systems like Veeva

Qualifications

  • High school diploma with at least 5 years of document control experience in GMP-regulated settings.
  • Proficient with Word, Excel, Acrobat and Visio; advanced Word features preferred.
  • Experience with Veeva QualityDocs or similar EDM systems.
  • Strong organizational skills and attention to detail in multi-priority environments.
  • Excellent communication and collaboration with internal customers and cross-functional partners.
  • Experience maintaining organized documentation and records for retention practices.
  • Exposure to validation processes and validated electronic systems is a plus.

Responsibilities

  • Provide responsive support to internal customers to promote timely project execution.
  • Create and revise procedures and execution documents in line with processes and timelines.
  • Process, distribute, and maintain GMP documentation across production, testing, validation, and quality records.
  • Perform document control reviews using checklists to verify templates, formatting, and requirements.
  • Contribute to continuous improvement of document control tools, checklists, and SOPs.
  • Take on additional duties to support Quality team objectives.

Skills

Document control
GMP
MS Word
MS Excel
Adobe Acrobat
Visio
Veeva QualityDocs
Validation
Record retention
Cross-functional collaboration

Education

High School Diploma

Tools

Veeva QualityDocs

Job description

Planet Pharma in Newark, CA seeks a detail-oriented Document Control Specialist to support controlled-document lifecycles across production, testing, validation, and quality operations within a GMP environment. You will collaborate with cross-functional partners, maintain templates, and ensure timely, accurate documentation.

The role emphasizes strong organizational skills, proficiency with Word/Excel/Acrobat/Visio, and experience with electronic document management systems like Veeva

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